Exposing The Dangers of Antidepressants Despite Cover-Ups

CCHR:
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oi AN+iuiviss.N+s .Nu
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Disvi+i IDA/Isvcni.+ic-
In.x.cii+ic.i Covi-Uvs
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Cnixic.i Ixn.i.Nci Tniov +o Siii Dios
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IN+ouic+ioN: Tni Ass.ii+ oN CoNsixi Io+ic+ioN
Cn.v+i ONi: Ii-Ioz.c Avvov.i

Cn.v+i Two: DiNviNo CoNsixis +ni Ti+n

Cn.v+i Tnii: Tni CoNiiic+s oi IN+iis+ INci.si
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Cn.v+i Iivi: CoviiNo Uv Wi+nu.w.i Svxv+oxs
Cn.v+i Six: Isvcni.+ic Dios C.isi Scnooi
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Cn.v+i Iion+: i.cx ox W.NiNos+ni Ti+n
Anoi+ Siiciui Rivi.iiu
Cn.v+i NiNi: Tni IDA is UN.viiiu
Cn.v+i TiN: ViNuic.+ioN s +ni Nix+ S+iv

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Preamble: In the interests of consumer protection, this report is a history of the cover-
up of antidepressant risks and CCHRs vigilant exposure of this and other dangerous
psychotropic drugs. Parents, whistleblowers and legislators are also among the many
that saw the need to warn others about these drugs and how vested interest groups
fought to ensure consumers didnt know the truth. This is a resource document for
anyone who wants to know the facts. The report tracks key events spanning 20 years
and is a resource for those wanting the facts.
Hov far vouId a muIli-biIIion doIIar induslry go lo rolecl ils inleresls vhen lhrealened
vilh ubIicily of ils knovIedge lhal ils roducls couId cause suicide, vioIence and dealh`
Whal vouId il do lo siIence lhose lhal knev lhe lrulh and exosed il` Why vouId a
governmenl agency aIIov such an induslry lo gel avay vilh lhis, eseciaIIy al lhe olenliaI
risk of miIIions of eoIes Iives lhal lhey vere svorn lo rolecl`
Consider lhal fraud invoIves inlenlionaI decelion or deIiberale misreresenlalion lo
secure money, righls, roerly or riviIege. In generaI lerms, fraud means dishonesl
deaIings, chealing or lrickery, mosl ohen invoIving money. This is a reorl on hov miIIions
of consumers in lhe Uniled Slales and around lhe vorId vere deceived aboul medicalions
lhal lhey vere loId correcled a chemicaI imbaIance in lhe brain lhal doesnl exisl.
IharmaceulicaI manufaclurers used lhe lheory lo conducl cIinicaI drug lriaIs lo roduce
drugs lo lreal lhe imbaIance.
They manufaclured drugs for disorders calaIogued in sychialrys Diagnostic and Statistical
Manual of Mental Disorders (DSM) lhal has never slood lhe lesl of science. As a 2006 sludy
delermined, 56% of lhose sychialrisls delermining vhal disorders vere incIuded in lhe
DSM vere harmaceulicaI funded. ased on lhe DSM, more lhan $100 biIIion of laxayers
money is exended every year on sychialric services in lhe Uniled Slales, and biIIions
more around lhe vorId.
Surious cIaims aboul menlaI disorders being caused by chemicaI imbaIances or
neurobioIogicaI dysfunclion are used lo convince lhe U.S. Iood and Drug Adminislralion
lo arove drugs lo lreal lhem. The agency doesnl require scienlic roof of lhe veracily
of lhese cIaims. In 2006, IDA Commissioner Dr. Andrev C. von Ischenbach vrole lhal lhe
IDA reIies mereIy uon lhe agreemenl of lhose ve consider exerls lo delermine vhal a
disease is and lhe facl lhal lhere are no Iaboralory lesls, lo diagnose menlaI disorders,
for examIe, Auenlion Decil Hyeraclivily Disorder (ADHD), does nol mean lhal il is
nol a neurobioIogicaI disease.
Imagine a hearl surgeon diagnosing a hearl defecl and erforming by-ass surgery vilhoul
any hysicaI conrmalion of irreguIarily, or an oncoIogisl diagnosing cancer and rescribing
chemolheray based on lhe generaI agreemenl lhal cancer exisls bul never verifying il
vilh hysicaI lesls.
}ohn Read, senior Ieclurer in sychoIogy al AuckIand Universily in Nev ZeaIand slaled
lhal Making Iisls of behaviors, aIying medicaI-sounding IabeIs lo eoIe vho engage
in lhem, and lhen using lhe resence of lhose behaviors lo rove lhey have lhe iIIness in
queslion is scienlicaIIy meaningIess. Il leIIs us nolhing aboul causes or soIulions. Il does,
hovever, creale lhe reassuring feeIing lhal somelhing medicaI is going on.
1

WhiIe in generaI medicine medicalions are deveIoed for exisling diseases, in sychialry
IN+ouic+ioN:
Tni Ass.ii+ oN CoNsixi Io+ic+ioN
2 CCHR: IxvosiNo +ni D.Nois oi AN+iuiviss.N+s .Nu O+ni Isvcno+ovic Dios
lhe business is seeking nev disorders for exisling drugs. KeIIy Ialricia OMeara, an avard-
vinning |ournaIisl, aulhor and former CongressionaI sla oinled oul, Drug comanies
uII a menlaI disorder oul of lhe DSM hal and gel IDA arovaI lo use an aIready exisling
drug lo lreal il. WeII-knovn sychialrisls are enIisled lo ubIicIy arm lhe disorder as a
sociaI robIemVoiIa! Conrmed sychialric iII and magic iII.
2

Drug Sales vs Consumer Protection
SeIeclive Serolonin Reulake Inhibilor (SSRI) anlideressanlseven before lhey rsl reached
lhe markel in lhe Iale 1980svere knovn lo cause suicide, aggression and olher vioIenl
behavior. Tvo years before lhe IDA aroved Irozac lhere vas evidence lhal lhe rale of
suicide vilh lhe drug vas more lhan ve limes grealer lhan vilh an exisling anlideressanl
on lhe markel. Tvo monlhs before lhe drug vas aroved, lhere vas evidence of 15 suicides
Iinked lo il. Anolher 12 dealhs vere aIso knovn of. Desile lhe slarlIing falaIilies, lhe IDA
aroved lhe drug on December 29, 1987.
When lhe Cilizens Commission on Human Righls (CCHR) and concerned medicaI
rofessionaIs exosed lhe cIear evidence of suicide risk, sychialry and ils harmaceulicaI
cohorlsrolecled by lhe IDAmounled a veII-funded camaign lo siIence ileseciaIIy
CCHR. CCHRs discIosure of lhe olenliaI deadIy eecls and coverage of lhis in |usl one
Wall Street Journal arlicIe Ied lo slock nose diving, vilh more lhan $600 miIIion Iosl in a
singIe day.
CCHRs exosure of lhe olenliaIIy IelhaI side eecls vas so lhal consumers vere given all
lhe knovn informalionand if lhe risks vere subslanliaI enough, lo remove lhe drug from
lhe markel. Il vas rimariIy a consumer roleclion issue. Aher aII, in 1989, lhe IDA had
recaIIed lhe naluraI amino acid L-lrylohan aher being Iinked lo lvo dealhs. L-lrylohan,
vhich acls on serolonin as aIIegedIy Irozac does unnaturally, had been in use for years
vilhoul incidenl. Desile lhe facl lhal lhe dealhs vere lraced lo a singIe lainled balch, lhe
IDA vilhdrev L-lrylohan. Why couIdnl il do lhe same vilh an anlideressanl lhal had
27 dealhs Iinked lo il al lhe lime` Il had aIso removed an anlideressanl from lhe markel,
MerilaI, because of falaI slrokes. ul lhere vas much more al slake vilh Irozac, a besl
seIIer vilhin a year of going on lhe markel and saIes reaching $1 biIIion in 1991.
Sleven Gerber, securilies anaIysl vilh aleman IichIer loId lhe Los Angeles Times in 2002, lhe
saIes vouId have been subslanliaIIy higher vere il nol for CCHRs camaign.
3

In 2003, a former execulive of lhe manufaclurer of Irozac loId The Hartford Courant lhal
al lhe heighl of lhe conlroversy CCHR vas generaling, lhe comany had an IDA ociaI
defending il againsl exosure of risks in lhe media, advocaling lhal lhe anlideressanls risk
of suicide vas mereIy a ubIic reIalions robIem.
Isychialrisls and lhe American Isychialric Associalionlhe Ialler reIying uon harmaceulicaI
funding lo survivereferred consumers didnl have aII lhe facls. In Augusl 1991, lhe
AIA issued a ress reIease suorling lhe IDAs decision nol lo remove Irozac from lhe
markel, cIaiming lhal il had demonslraled ils reIalive safely and eecliveness and lhal
deression, nol Irozac caused suicide. Al lhe lime, more adverse reaclions regarding
Irozac had been reorled lo lhe IDA lhan any olher drug on lhe markel. Since lhen, an
eslimaled 63,000 eoIe have commiued suicide vhiIe laking lhis lye of anlideressanl.
In 1996, vhen confronled by a series of CCHR ubIicalions maiIed lo severaI miIIion
CCHR: IxvosiNo +ni D.Nois oi AN+iuiviss.N+s .Nu O+ni Isvcno+ovic Dios 3
individuaIs and grous and avaiIabIe lo miIIions more on lhe Inlernel, lhe AIA
acknovIedged lhe robIem of CCHR in a memo daled }uIy 15. Il slaled: Their veb
siles and Iinked siles are geuing more daiIy hils lhan ours and, ossibIy, more lhan
aII menlaI heaIlh/sychialry veb siles lolaIed. Il lhen delaiIed a Iisl of roosed
relaIialory resonses.
As lhis reorl shovs, desile lhis, CCHR conlinued lo exose lhe fraud of lhe chemicaI
imbaIance in lhe brain manlra, lhe dangers of nol |usl anlideressanls bul aIso olher
sychialric drugs, and lhe monooIy lhal sychialry had on vhal lrealmenls eoIe
vilh menlaI heaIlh robIems vere suosed lo use. Il vas a 14-year bauIe, vilh more
and more eoIe recognizing and exosing anlideressanl risks, before lhe IDA
naIIy ordered bIack box varnings lhal SSRI anlideressanls couId cause suicide in
chiIdren and adoIescenls.
In 2005, lhe AIAs residenl, Slehen Sharfslein and olher sychialrisls vere forced lo
admil lhere is no Iab lesl lo rove a chemicaI imbaIance in lhe brain causing any menlaI
disorder. The markeling hoax vas naIIy exosed bul by lhen 30 miIIion Americans
vere laking lhe drugs. In }anuary 2008, lhe New England Journal of Medicine vindicaled
CCHR vhen a sludy il ubIished reveaIed lhe eecliveness of anlideressanls had
been exaggeraled and lhal many negalive sludies of lhe drugs vere never ubIished.
In facl, lhe drugs are no more eeclive lhan laking Iacebo (dummy iII).
The foIIoving reorl delaiIs lhe hislory of lhe cover-u and lhe laclics laken by
sychialrisls lo misdirecl consumers and IegisIalors aboul bolh lhe science of lheir
disorders and lhe dangers of lhe drugs used lo lreal lhem. Many of lhe documenls
reIaling lo lhe IDA, CCHR oblained lhrough Ireedom of Informalion Acl (IOIA)
requesls in 1992-1993. AddilionaIIy, doclors leslifying in civiI suils invoIving
anlideressanls had access lo inlernaI harmaceulicaI comany documenls lhal vere
evenluaIIy made ubIic.
SincereIy,
}an Iaslgale
InlernalionaI Iresidenl
1978: AIlhough lhis informalion vouId nol be made knovn unliI 200 Iavsuils vere
Ied in reIalion lo lhe nev anlideressanl, Irozac, in lhe 1990s, lhe manufaclurer, IIi
LiIIys ovn documenls shoved lhal as earIy as 1978-10 years before ils arovaI in lhe
U.S.lhal in some alienls, Irozac induced agilalion, sychosis, akalhisia |from Greek
a meaning vilhoul or nol and kathisia meaning siuing lhal can be accomanied
by vioIenl oulburslsj and reslIessnessvhich can be recursors of suicide: There have
been a fairIy Iarge number of reorls of adverse reaclions... Anolher deressed alienl
deveIoed sychosis...Akalhisia and reslIessness vere reorled in some alienls... Some
alienls have converled from severe deression lo agilalion vilhin a fev days, in one
case lhe agilalion vas marked and lhe alienl had lo be laken o |lhej drug... As a
recaulionary measure, lhe comany added lranquiIizers (benzodiazeines) lo conlroI
fulure agilalion in fulure re-markeling lriaIs.
4
Three Iacebo-conlroIIed sludies vere rovided for lhe IDA lo arove Irozac, lhe rsl
SSRI (SeIeclive Serolonin Reulake Inhibilor) anlideressanl. One demonslraled no
eecl, vhiIe lhe second, caIIed IrolocoI 27, vhere Irozac vas comared lo imiramine
(an oIder anlideressanl) and Iacebo, found Irozac lo be inferior in eecliveness. The
lhird sludy, invoIving onIy 11 eoIe and onIy ve veeks in duralion, found a osilive
resuIl. The manufaclurer, IIi LiIIy, delermined lhe score vas lvo lo one in favor of
Irozac.
5

September 13, 1984: Dr. Irances O. KeIsey, Direclor of Division of Scienlic Invesligalions,
Oce of ComIiance al lhe IDA, vrole lo some of lhe invesligalors on IrolocoI 27,
ciling vioIalions in lhe cIinicaI lriaIs.
November 13, 1984: Tony DeCicco, IDA Consumer Safely Ocer, recorded lhe
minules of an in-house IDA meeling lhal discussed Irozac and slaled: This agency
has discovered a av in lhe exerimenlaI design and execulion of lhe uoxeline
|Irozacj sludies and lhal lhe vay lhe sludies vere conducled couId Iead lo a biased
comarison.
November 13, 1984: In a IDA Memorandum, il slaled, This Agency musl inform
LiIIy earIy on, lhal ve have robIems vilh lheir anaIysis because of lhe Iarge number
of droouls. Dr. David Graham, an eidemioIogisl vilh lhe IDA slaled, The rms
anaIysis of suicidaIily does nol resoIve lhe issue. According lo lhis same documenl, even
LiIIy acknovIedged lhal ils cIinicaI lriaIs vere nol designed lo sludy lhis and lhal lhe
quaIily and secicily of dala lo be gIeaned from lhese lriaI lo address suicidaIily vere
oor. Dr. Graham concIuded lhal because of aarenl Iarge-scaIe under reorling,
lhe rms anaIysis cannol be considered as roving lhal uoxeline and vioIenl behavior
are unreIaled.
6

March 1985: An IDA memo shoved lhal }. HiIIary Lee, lhe IDAs Icacy Reviever for
Irozac, exressed concerns over IIi LiIIy inslrucling lheir invesligaling hysicians nol
lo incIude symloms of deression manifesling in lheir alienls during lheir cIinicaI
lriaIs as adverse reaclions. In lhe reviev of IrolocoI 27, for examIe, Lee anaIyzed
six sludies lhal comrised lhis il and delermined lhal one couId nol be incIuded, one
demonslraled lhal Irozac vas onIy sIighlIy more eeclive lhan Iacebo, vhiIe four
sludies shoved il lo be no more eeclive lhan Iacebo.
March 29, 1985: An IIi LiIIy memo admiued a rale of suicide for Irozac lo be 5.6 limes
higher lhan for lhe oIder lricycIic anlideressanl, imiramine.
7
The benels vs. risks
Cn.v+i ONi:
Ii-Ioz.c Avvov.i
consideralions for uoxeline |Irozacj currenlIy does nol faII cIearIy in favor of lhe
benels. Therefore, il is of grealesl imorlance lhal il be delermined vhelher lhere
is a arlicuIar subgrou of alienls vho resond beuer lo uoxeline (Irozac) lhan lo
imiramine, so lhal higher incidence of suicide auemls may be loIerabIe.
8

German aulhorilies exressed concern aboul Irozac causing akalhisia and suicide.
9

May 1985: A memo by lhe IDAs Safely Reviever Richard Kail slaled, Il is uoxelines
arlicuIar roIe of adverse side eecls vhich may erhas, in lhe fulure give rise lo
lhe grealesl cIinicaI IiabiIilies in lhe use of lhis medicalion lo lreal deression.
10

March 23, 1986: Dr. Kails reviev of lhe Irozac Nev Drug AIicalion (NDA)
found addilionaI adverse reaclions lhal lhe manufaclurer had nol submiued. These
invoIved lhe onsel of an unreorled sycholic eisode, may exacerbale cerlain
deressive symloms and olenliaI risks incIude inlensicalion of lhe vegelalive
signs and symloms of deression.
11
There vere 10 reorls of sycholic eisodes,
2 reorls of comIeled suicides, 13 auemled suicides, 4 seizuresincIuding in a
heaIlhy voIunleer, and 4 reorls of movemenl disorders.
12

1987
The German GA, lhe counlrys IDA equivaIenl, refused lo arove Irozac based on LiIIys
sludies shoving lhal reviousIy non-suicidaI alienls vho look lhe drug had a vefold higher
rate of suicides and suicide aempts lhan lhose laking oIder anlideressanls, and a lhreefoId
higher rale lhan lhose laking Iacebos.
May: The American Isychialric Associalion udaled ils Diagnostic and Statistical Manual,
adding anolher 29 menlaI disorders bringing lhe lolaI lo 253. The DSM-II, ubIished
in 1980, added 61 nev disorders. Since ils 1994 edilion, lhere has been a 256% increase in
anlisycholic and anlideressanl drug saIes.
September 14: An IDA Safely Udale Segmenl 3 reorl on adverse reaclions, dealhs and
olenliaIIy serious evenls recorded 5,620 alienls lrealed vilh uoxeline in lhe U.S. and
7,948 on lhe vorIdvide dalabase. There vere 13 dealhs reorled vorIdvide, auribuling
lhem moslIy lo hysicaI condilions, of vhich 8 dealhs vere aarenl suicides.
13

December 17: In a memo, lhe IDAs Consumer Safely Ocer Arlhur K. YeIIin noled, LiIIy
reresenlalives advised lhal lhey very inlenlionaIIy vished lo refrain from romoling lhis
asecl |anorexiaj of Irozac al lhis lime lhal lhe IDA agreed lo.
14
A memo from Dr. Kail of
lhe same dale, references 4 cardiac-reIaled dealhs, 30 cases of mania, hyomania, or manic
sychosis reorled. Tvenly of lhese cases vere disconlinued as a resuIl of lhese adverse
eeclsThere vere 18 alienls vho look overdoses of uoxeline, Iess lhan 1000 mg.
15

December 29: The IDA aroved Irozac for lhe markel.
December 30: The IDAs NeuroharmacoIogicaI Drug Division, under lhe Ieadershi of
sychialrisl IauI Leber, aroved Irozac for lhe markel.
16
y Oclober 1989, lhere vere
5,740 adverse reaclions reorled lo lhe IDA. As CCHR vouId reorl, in conlrasl lhe
anlideressanl IIaviI, vhich had been on lhe markel for 20 years, accumuIaled 2,923 adverse
reaclion reorls as of November 1989nearIy lvice as many reorls on Irozac as lhere
vere on IIaviI in Iess lhan one-lenlh of lhe lime.
17

1988
January 20: Memo by IDAs Safely Reviever Richard Kail said lhal he had conlacled
lhe cIinicaI research division of IIi LiIIy aboul four unreorled seizures suered by
eoIe laking uoxeline. Kail said il vas an error lhal il vas nol reorled.
18

1989
September 14: }oseh Wesbecker of LouisviIIe, Kenlucky, vhiIe under lhe inuence
of Irozac, gunned dovn 8 co-vorkers and vounded 12 olhers before kiIIing himseIf
al lhe Slandard Gravure rinling Ianl. Three days rior, Weskbeckers sychialrisl
described him as exhibiling an increased IeveI of agilalion and anger, adding,
IIanDisconlinue Irozac vhich may be cause.

September: A ubIished medicaI reorl eslimaled lhal belveen 10% and 25% of
Irozac users exerienced akalhisia, making il a common side eecl, vhiIe IIi LiIIys
roducl informalion onIy acknovIedged lhal lhe condilion occurs in Iess lhan 1%.
19

(Akalhisia: a, vilhoul, kathisia, siuing, an inabiIily lo kee sliII, a severe reslIessness
lhal can cause agilalion and sychosis.)
October-November: The coroners inquesl inlo lhe Wesbecker kiIIings vas heId, al
vhich CCHR leslied aboul sychialric drugs causing vioIence. Coroner Dr. Richard
Grealhouse delermined lhal Wesbecker had a high lheraeulic IeveI of Irozac in his
bIood. The |ury ruIed lhal lhe eecls of lhe drugsmay have been a conlribulory
faclor lo lhe ramage. Dr. Grealhouse slaled, Irozac in cerlain individuaIs has
caused a vioIenl hosliIe lye of reaclion.
20

1990
CCHR did hundreds of media inlervievs lhroughoul 1990 aboul lhe dangers of lhe
nev anlideressanl and hov il couId drive users lo commil murder.
January 30: IIi LiIIy Ieuer lo saIes reresenlalives gave lhem a heads u on lhe
ucoming Dr. Marlin Teicher sludy (see nexl enlry), slaling, ecause lhese issues
(suicide) are nol arl of our currenl markeling Ian, you shouId nol iniliale discussions
on lhese arlicIes.
21

February: MedicaI sludies reorled vioIenl and suicidaI reaclions in eoIe laking Irozac.
Dr. Marlin Teicher from Harvard MedicaI SchooI described hov Irozac couId generale
inlense, vioIenl suicidaI lhoughls in a signicanl orlion of ersons laking il.
22

February 7: In a memo, Leigh Thomson, grou vice residenl of LiIIy Research
Laboralories, slaled, Anylhing lhal haens in lhe UK can lhrealen lhis drug in lhe
U.S. and vorIdvide. We are nov exending enormous eorls fending o auacks
because of (1) reIalionshi lo murder and (2) inducing suicidaI idealion.
23
Iurlher,
Im concerned aboul reorls I gel re UK auilude lovard Irozac safelyI hoe Ialrick
(a LiIIy medicaI direclor in rilain) reaIizes lhal LiIIy can go dovn lhe lubes if ve Iose
Irozac and |usl one |adverse reaclionj evenl in lhe UK can cosl us lhal.
24
Thomson
aIso said lhal aIlhough lhe IDAs IauI Leber is a fan of Irozac and beIieves a Iol of
lhis is garbage |suicidaI reaclionsj, he is cIearIy a oIilicaI crealure and viII need lo
resond lo ressures.
25
|See }uIy 30, 1990 enlryj
Cn.v+i Two:
DiNviNo CoNsixis +ni Ti+n
March: CCHR mel vilh Chief CounseI and Sla Direclor of lhe U.S. CongressionaI
Subcommiuee on Oversighl and Invesligalions, roviding research on anlideressanls
causing vioIence and suicide and requesling an invesligalion.
May 4: Max W. TaIbou Ih.D., LiIIy ReguIalory Aairs Associale, loId lhe IDA lhal
foIIoving hone conversalions vilh lhe agency over Irozac causing vioIenl, aggressive
acls, LiIIy vouId submil a summary of ils ndings bul uIlimaleIy cIaimed lhal Irozac
did nol cause such behavior.
May 15: The Irozac Survivors Suorl Grou (ISSG) formed lo exose lhe risk of
anlideressanls.
May 29: IIi LiIIy changed ils Irozac roducl informalion sheel lo add lhe lerm suicidaI
idealion in lhe smaII rinl of lhe seclion deaIing vilh osl-markeling reorls.
26

July 17: Irozac viclim Ronda HaIa Ied lhe rsl Iavsuil lo charge lhal Irozac couId
drive someone inlenseIy suicidaI and seIf-deslruclive.
27
She suered acule akathisia, a
drug-induced nervous reslIessness associaled vilh vioIenl behavior. She said il caused
her lo muliIale herseIf, gouge her esh vilh any shar inslrumenl she couId Iay her
hands on: screvs, scissors, shover hooks, carel lacks, razors, and ens. I had lo
hurl, HaIa loId Newsweek. You sil dovn and every nerve in your body has lo move.
You feeI Iike youre going lo |um righl oul of your skin.
28

July 18: Dr. Leigh Thomson soke vilh lhe rinciaI IDA reguIalor, IauI Leber
(direclor of lhe IDAs NeuroharmacoIogicaI Drug Division) al 6:15 in lhe morning
aboul lhe issue of suicide and Irozac and lhe desirabiIily for sludy dala lo comIemenl
anlicialed leslimony from exerls on suicide so lhal vouId malch chronoIogies.
Anolher memo of lhe same dale shoved lhe slralegy vas lo conducl sludies lo ul a
ca on lhe frequency of suicidaI idealion. When lvo members of lhe media caIIed
Leber aboul lhe ossibIe risk of suicide vilh Irozac, his resonse vas, I lrashed lhe
idea.
29

July 18: The Wall Street Journal reorled lhal CCHR vas coIIecling reorls of Irozac
adverse reaclions.
July 30: IauI Leber of lhe IDA loId TIME magazine: Iven if ve gol severaI hundred
reorls invoIving suicide and Irozac, ve vouIdnl be aIarmed...Deressed eoIe
commil suicide.
July: An IIIi LiIIy execulive circuIaled an inlernaI memo slaling lhal IauI Leber as
dismissing ress coverage of suicide concerns as lriviaI. In anolher memo LiIIys
Leigh Thomson recommended lhal LiIIy renl sace in a buiIding nexl lo Lebers
Washinglon oce so secure communicalion aboul Irozac lo lhe IDA couId be ensured.
Thomson soke lo Leber as ohen as lhree limes a veek during lhe conlroversy lhal
CCHR vas generaling. IauI Leber vas our defender againsl aII of lhe auacks in lhe
media, Thomson said. The ScienloIogisls vere reaIIy aher us and lhe simIesl lhing
for |lhe IDAj lo do vouId have been lo uII il o lhe markeland lhey didnl.
30

July 24: CCHR elilioned lhe Chairman of lhe U.S. House of Reresenlalives
Subcommiuee on Oversighl and Invesligalions lo remove Irozac from lhe markel
because of ils risks. The Wall Street Journal reorled lhis on }uIy 27, 1990.
July 31: The IDA issued a TaIk Iaer defending Irozac and said lhe agency had no
reorled cases of (inlense, vioIenl suicidaI lhoughls) simiIar lo lhose described by
Dr. Marlin Teicher in his sludy. |See Iebruary 1990 enlryj
August 3: An inlernaI IIi LiIIy Ieuer lo saIes reresenlalives advised lhem hov lo
ansver queslions aboul Irozac causing suicidaI idealion, slaling, You shouId nol
iniliale discussion on lhese issues bul if asked, reassure lhe heaIlhcare rofessionaI
lhal no causaI reIalionshi has been eslabIished belveen suicidaI idealion and Irozac
lheray.
31
|Leuer vas nol reIeased unliI 1999 in a civiI suil.j
August 8: CCHR resonded lo lhe IDAs TaIk Iaer lo IDA Commissioner }ames
S. enson demanding lhal consumers knov lhe lrulh: In lhe Iasl eighl monlhs, lhe
number of voIunlary reorls lo lhe IDA of suicide auemls by eoIe laking Irozac
had increased 372%The IDA is nov aIIoving Americans lo die vilh lhe erverled
defense lhal eoIe vho lake Irozac are deressed.lhe IDA uses lhis lo disguise
lhe facl lhal eoIe become suicidaI vhiIe laking Irozac and lhen kiII lhemseIves, and
in loo many reorled cases kiII olhers. Il rovided comarisons: In 31 months,
over 9,973 adverse reorls on Irozac had been reorled lo lhe IDA vhiIe over a 20-
year eriod, 6,343 reorls of adverse reaclions on VaIium had been reorled and 2,923
reorls on lhe anlideressanl drug IIaviI (Irozacs rime comelilor).
32

August 9: CCHR resenled furlher submissions lo members of Congress caIIing for
aclion lo be laken.
August 31: IIi LiIIy sends a Dear Doclor Ieuer assuring lhe doclors lhal lhere is no
causaI reIalionshi belveen Irozac and suicidaIily.
33

September 11: Dr. David Graham, seclion chief of lhe IDAs IidemioIogy
|delermining causes, dislribulion and conlroIIing sread of diseasesj ranch, vrole
lhal he had revieved dala from lhe cIinicaI lriaIs for Irozac and found lhal lhey vere
nol designed for lhe roseclive evaIualion of suicidaIily. He said, Trealmenl-
emergenl |i.e., nevj suicidaIily vas more frequenl among alienls laking Irozac
lhan among lhose receiving, oIder, lricycIic anlideressanls. Graham noled, lhe
rms anaIysis cannol be considered as roving lhal Irozac and vioIenl behavior are
unreIaled.
34
The IDA ignored his concerns.
September 12: A Leigh Thomson (IIi LiIIy) memo indicaled lhal IauI Leber (IDA)
vas under ressure vilhin lhe IDA lo add a varning lo Irozacs roducl informalion
before lhe IDA couId hoId a hearing on lhe mauer of suicidaIily.
35

September 14: Dr. Thomson aIso loId IIi LiIIys oard of Direclors lhal suicide and
acls of vioIence vere, in aII robabiIily, causaIIy reIaled lo lhe alienls underIying
menlaI disorder, vhiIe LiIIy sla vere concerned lhal lhe issue vas never sludied
during lhe cIinicaI lriaIs.
36
In anolher memo, }ohn HeiIigenslein of IIi LiIIy loId
Thomson, We feeI caulion shouId be exercised in a slalemenl lhal suicidaIily and
hosliIe acls in alienls laking Irozac reecl lhe alienls disorder and nol a causaI
reIalionshi lo IrozacIoslmarkeling reorls are increasingIy fuzzy and ve have
assigned Yes, reasonabIy reIaled on severaI reorlsYou may vanl lo nole lhal
lriaIs vere nol inlended lo address issue of suicidaIily.
37

September 25: IDA Meeling Minules vriuen by IauI A. David, Consumer Safely
Ocer, lo IDA members and IIi LiIIy execulives aboul osl markeling safely
exerience vilh Irozac, in vhich il vas slaled lhal suicidaI behavior vas of concern.
Leigh Thomson from IIi LiIIy said lhere vas no correIalion belveen suicide and
Irozac. Il vas recommended lhal LiIIy hoId a symosium on suicidaIily vilh lhe
NalionaI Inslilule of MenlaI HeaIlh.
38
IssenliaIIy il ignored Dr. Grahams ndings of
Selember 11.
39

October 2: A Leigh Thomson memo lo LiIIy emIoyee Roberl Zerbe regarding lhe
roseclive suicidaIily symosium noled, Then lhe queslion is vhal lo do vilh lhe
big numbers on suicidaIily. If lhe reorl numbers are shovn nexl lo lhose for nausea,
lhey seem smaII.
40

October: Thomas DonneIIy, an execulive from lhe lhen SmilhKIine eecham (nov
GIaxoSmilhKIine), manufaclurer of lhe anlideressanl IaxiI (aroxeline), circuIaled a
memo recounling a leIehone conversalion vilh lhe IDA ociaI, Dr. Marlin recher,
vho vas erforming lhe governmenls sludy of IaxiIs safely and requesled informalion
on any olenliaI suicide risk. He said lhal recher and lhe IDA did nol see il as a reaI
issue and inslead considered lhe concerns a ubIic reIalions robIem.
41

October 11: CCHR submiued a Cilizens Ielilion lo lhe IDA oulIining lhe evidence
shoving lhal Irozac drove ersons vioIenlIy insane and caIIed for vilhdravaI of lhe
drug from lhe markel lo rolecl consumers. In an addendum daled November 1,
CCHR submiued lhal lhe anlideressanl vas aIso addiclive.
November 13: IIi LiIIy requesled lhal ils comany in Germany change lhe adverse
drug evenl suicidaI idealion lo say deression vhen reorling lo lhe GA (German
equivaIenl lo lhe IDA). A memo from CIaude ouchy of LiIIy in Germany resonded,
I do nol lhink I couId exIain lo a GA, a |udge, lo a reorler or even lo my famiIy vhy
ve vouId do lhis, eseciaIIy on lhe sensilive issue of suicide and suicidaI idealion.
42
|Leuer nol reIeased unliI 1999 during a civiI suil.j In anolher memo, Leigh Thomson
vrole, Id suggesl lhal ve (1) rolecl Irozac.
43

During lhe year, a sludy conducled al lhe Universily of Iiusburgh MedicaI SchooI vas
aIso ubIished documenling a nev drug, Lovan as eeclive for veighl reduclion.
Lovan vas uoxelinelriIe slrenglh Irozac markeled a veighl Ioss iII.
44
If aroved
lhe drug vouId have reaed IIi LiIIy $55 miIIion in 1991. In 1994, LiIIy vilhdrev ils
Nev Drug AIicalion in lhe Uniled Slales for Lovan.
45

1991

January 10: IIIinois Chief }udge WiIIiam A. Levis vrole of having senlenced a Larry
WaIlers lo robalion for lhe second degree murder of his falher saying lhal lhe falher
vas on Irozac vhich ossibIy caused him lo go on an exlremeIy vioIenl ramage
resuIling in his son kiIIing him in seIf defense.
January 31: Dr. Thomas Kurl of lhe IDAs Soulhvesl Region aIerled lhe IDA
headquarlers in a memo aboul Ten Dealhs WhiIe on Irozac (uoxeline) in DaIIas
Counly in One Year.
46

February 7: Three medicaI doclors reorled in The New England Journal of Medicine
alienls in vhom suicidaI idealion and uoxeline |Irozacj lrealmenl vere slrongIy
associaled. A 58-year-oId man vas slarled on uoxeline (20 mg/day). Three days
Ialer he had vioIenl suicidaI lhoughls and lried lo hang himseIf vilh a roe. The
uoxeline vas disconlinued, vilh a comIele disaearance of suicidaI idealion four
days Ialer.
47

March 29: Dr. Thomas Laughren, head of lhe Isychialric Drug Iroducls Division of
lhe IDA vrole a memo cIarifying lhe queslion of suicidaIily in associalion vilh Irozac
and acknovIedged lhal lhe issue vas raised by CCHR in ils Cilizens Ielilion vhere
lhere vere occurrences of deression/suicidaI idealion in non-depressed individuaIs
being lrealed vilh lhe drug. He recommended lhal lhe roducl informalion sheel for
Irozac incIude a slalemenl aboul suicidaI lhoughls.
48

March: Roberl A. King, M.D., and olhers of YaIe Universily SchooI of Medicine
ubIished a sludy in lhe Journal of the American Academy of Child and Adolescent Psychiatry
regarding lhe emergence of inlense seIf-in|urious behavior found in six adoIescenls
aged 10 lo 17 years oId laking Irozac.
49

April 1: Leigh Thomson defended reorls lhal Irozac caused vioIence, bIaming lhe
reaclion inslead on menlaI iIIness.
50
Wilh Irozac saIes reaching $1 biIIion, lhe drug
vas rolecled, desile lhe risks lo individuaI and ubIic safely.
51
|See Selember 14,
1990 enlryj
April 15: Memo lo Leigh Thomson aboul ucoming TV aearance on 20/20, headed
MISSAGI GOALSWhalever queslions you are asked or direclion lhe inlerviev
|sicj lake, lhe lhree oinls lhal ve vanl lo eslabIish are: (2) Ils in lhe disease, nol
lhe drug.If ressed, or as a oslscril lo lhe above, lhen make lhe oinl lhal
absoIuleIy no evidence indicales lhal IROZAC as a cause of such behavior |suicide
and vioIencej.
52

May: AIan GeIberg, Acling Chief of lhe SurveiIIance & Dala Irocessing ranch of
lhe IDA, slaled: Since markeled in 1988, by IIi LiIIy, Irozac (uoxeline) has had lhe
highesl number of adverse evenl reorls submiued lo lhe IDA NalionaI Adverse Drug
Reaclion Reorling (ADR) Syslem dalabase. The dalabase dales back lo 1969. In 1990,
Irozac had lhe Iargesl number of reorls. |y Selember 15, 1993, lhe IDA ADR
Dalabase had Iogged over 28,600 adverse reaclion reorls on Irozac.j
53

May: Dr. WiIIiam Wirshing, a UCLA sychialrisl, reorled lo lhe annuaI meeling
of lhe American Isychialric Associalion (AIA) lhal ve alienls aeared lo have
Cn.v+i Tnii:
Tni CoNiiic+s oi IN+iis+ INci.si
deveIoed akathisia from Irozac. Dr. Wirshing beIieved lhe akalhisia had Ied lhem aII
lo conlemIale suicide.
54

May 9: The nalionaI AC TV shov Irime Time ran a slory on Irozac, lilIed, Whal
made lhem do il` in vhich Leigh Thomson denied lhal lhe drug couId cause suicide
or vioIence.
June 3: CCHR vrole lo IDA Commissioner Dr. David KessIer aboul Irozac having
more ADRs lhan any olher drug. Since December 1989, more lhan 3,000 eoIe had
reorled lo CCHR aIone adverse reaclions associaled vilh Irozac, incIuding suicidaI
lhoughls and behaviors, hosliIily, vioIence, seIf-muliIalion, agilalion, and sychosis.
CCHR had aIso recorded lhal ersons laking lhe drug had murdered more lhan 34
eoIe. |See }une 2, 1993 enlry re: KessIers admission lhal onIy 1% of adverse reaclions
vere reorled lo lhe IDA.j

June 18: IIi LiIIys Leigh Thomson loId The IndianaoIis Nevs lhal lhere vere
scienlic vays lo delermine if a alienl vas IikeIy lo kiII him or herseIf and lhal lhe
comany vas vorking vilh NIMH and lhe IDA on deveIoing a suicide assessmenl
scaIe.
55
|See Selember 25, 1990 enlry.j Hovever, aII suicide assessmenls are based on
sub|eclive, nol scienlic-based queslions.
July 26: The IDA denied CCHRs Cilizens Ielilion, cIaiming lhal Irozac vas safe and
eeclive and ve do nol beIieve lhere is evidence lhal Irozac causes suicidaIily or
olher vioIenl lhinking or behavior.
56
Hovever, il agreed lo convene a meeling of ils
IsychoharmacoIogicaI Drugs Advisory Commiuee |IDACj lo consider lhe issue of
suicidaIily associaled vilh anlideressanl drugs, incIuding Irozac.
August 7: CCHR vrole lo Dr. Louis W. SuIIivan, Secrelary of lhe Dearlmenl of HeaIlh
and Human Services requesling an invesligalion inlo vhy lhe IDA had dismissed
lhe ADRs on Irozac and vhy ils TaIk Iaer vas reIeased lo IIi LiIIy and olher
sychialric lrade organizalions in advance of ils ubIic reIease lo reare a resonse,
vhiIe lhe same oorlunily vas nol given CCHR.
57

August 8: IDA Minules of Meeling re: Irozac vriuen by IauI A. David, R.Ih.,
Consumer Safely Ocer. Meeling vas sonsored by IIi LiIIy and auended by IDA
ociaIs Dr. IauI Leber, Dr. Thomas Laughren, Dr. C. ArneIIo and IauI David lo discuss
lhe ucoming IDAC hearing on Selember 20. Dr. Leber said lhe hearing vas lo
rovide fuII ubIic scruliny and Commission discussion aboul lhe aIIegalions of
vioIence and suicide Iinked lo anlideressanls. Leber vanled il slressed lhal because of
lhe high number of aII adverse reaclions reorled on Irozac (15,000), lhal lhere shouId
be a resenlalion on lhe Iimilalions of Sonlaneous Reorling Syslem (SRS) lo lhe
IDA. Dr. C. AneIIo disagreed. The memo slaled, In viev of lhe imorlance auached
by crilics of Irozac lo lhe voIume of reorls received, Dr. Leber urged Dr. ArneIIo lo
reconsider, bul agreemenl on lhis issue vas nol reached. The SRSs Dearlmenl of
IidemioIogy and SurveiIIance (DIS) vas urged lo reviev aII reorls of comIeled
suicide bul il vas decided in advance of lhe IDAC hearing lhal, lhe reviev vouId
mosl IikeIy Iead lo a concIusion lhal lhe informalion vas inadequale lo suorl such
an assessmenl, bul subslanlialion of lhis oinl vouId be usefuI.
58

August 23: CCHR Ied a comIainl vilh IDA Commissioner Dr. David A. KessIer
aboul lhe IDA Ianning lo onIy hoId a one-hour hearing lo reviev lhe concerns aboul
Irozac and requesled lhe IDAC hearing be exlended lo a fuII day. |SubsequenlIy
exlended lo one dayj
September 10: CCHR vrole Dr. KessIer aboul lhe conicls of inleresl in lhe ucoming
IDAC hearing delaiIing lhe nanciaI Iinks belveen ils sychialric members and drug
manufaclurers, incIuding IIi LiIIy, Sandoz, SmilhKIine eecham, Merck, risloI Meyers
Squibb and Izer. Nine oul of 10 aneI members had nanciaI conicls regarding
anlideressanls, vilh 8 being sychialrisls, lhose mosl IikeIy lo make a Iiving by
rescribing anlideressanls. This incIuded Dr. David Dunner vho had nanciaI
inleresls lolaIing a haIf miIIion doIIars. CCHR found lhal Dunners conicl of inleresl
vaiver vilh lhe IDA faiIed lo discIose lvo ending granls vorlh $250,000 from lvo
harmaceulicaI comanies and lhal he had a series of engagemenls lo seak al a
series of seminars funded by IIi LiIIy. He had aIso received more lhan $4 miIIion in
research granls from anlideressanl manufaclurers in lhe 8 years receding lhe IDA
hearing. The lenlh aneI member vas a sychoIogisl in lhe dearlmenl of sychialry
al lhe Universily of Iiusburgh vho vas aIso a member of lhe Scienlic CounciI of
lhe NalionaI AIIiance for Research on Schizohrenia and Deression, an organizalion
heaviIy backed by drug comanies.
59

September 20: The IDAs IDAC heId a hearing inlo anlideressanls causing suicidaI
idealion/behavior in alienls and vhelher a ackage inserl shouId varn lhe drug couId
cause suicidaI behavior. CCHR resenled evidence aIong vilh dozens of anlideressanl
viclims. The evidence given by alienls and lheir famiIies lo lhe IDA hearing vas
dismissed as anecdolaI. Dr. Marlin Teicher, vho had sIides lhal shoved hov Irozac
couId cause suicidaIily, vas denied lhe righl lo resenl lhis evidence. Isychialrisls
reresenling IIi LiIIy made haIf of lhe formaI resenlalions on lhe agenda, even
lhough lhe IDAs memo on lhe olenliaI conicls of inleresl said lhal lhe commiuee
vouId nol be deaIing vilh or revieving any secic drug or sonsor (manufaclurer).
Isychialrisls varned IDAC lhal any changes in Irozac IabeIing vouId undermine
lhe ubIics condence in sychialric drugs.
60
The commiuee voled unanimousIy lhal
anlideressanls did nol cause suicide and vioIenl behavior. |Dr. David Dunnersee
above enlryvhiIe nol arlicialing in lhe acluaI vole, vas an advisory member.j
October 3: Dr. Roberl TemIe, Direclor of lhe Oce of Drug IvaIualion and Research,
Dearlmenl of HeaIlh and Human Services resonded lo CCHRs Ieuer of Augusl 7, and,
nol surrising, suorled lhe ndings of lhe IDAC hearing, vhich he had auended.
Documenls Ialer oblained lhrough lhe Ireedom of Informalion Acl reveaIed lhal
LiIIys cIinicaI sludies lhal vere resenled lo lhe 1991 IDA hearing vere knovn lo
be inadequale.
61
Dr. TemIe vas senior lo lhe Division of NeuroharmacoIogicaI
Drug Iroducls, headed by IauI Leber. In 1984, Dr. TemIe had aroved anolher
anlideressanl, MerilaI, for use, bul six monlhs Ialer lhe drug vas vilhdravn from lhe
markel because of falaI slrokes and hemoIylic anemialhe excessive deslruclion (for
examIe by chemicaI oisoning) of red bIood ceIIs. The manufaclurer vas criminaIIy
roseculed for faiIing lo reorl dealhs and adverse reaclions.
62
TemIe Ialer leslied
before a CongressionaI hearing lhal lhe IDA knev lhe drug had risks, bul he beIieved
lhe benels oulveighed lhese. Mosl, markeled anlideressanl drugs are knovn
lo be associaled vilh muIliIe risks, some of lhem quile serious and aIso olenliaIIy
falaI.
October: In lhe U.S., NalionaI Deression Screening Day began as an annuaI
Oclober evenl, funded vilh a granl from IIi LiIIy. Thousands of siles in hosilaIs,
cororalions and universilies around lhe counlry rovided free deression screening
lhal invoIved eoIe ansvering a sub|eclive queslionnaire Iasling Iess lhan 5 minules.
They lhen valched a video on hov lrealabIe deression vas.
63

December: In a Harvard MedicaI SchooI sludy, ubIished in The Journal of Clinical
Psychiatry, lhe researchers noled, lhree deressed inalienls lhal had auemled
suicide vhiIe laking Irozac, vere recommenced on lhe drug. In each case, lhey
deveIoed akalhisia and commenled lhal il vas lhe same syndrome lhal reciilaled
lheir earIier suicide aueml. They again deveIoed suicidaI idealion, vhich abaled
onIy vhen lhey vere disconlinued on Irozac.
64

1992
January: The IDA aroved ZoIoh for lhe markel.
March 22: CCHR Ied a comIainl vilh I. Gary Davis, GeneraI CounseI for lhe Oce
of Governmenl Ilhics aboul lhe conicls of inleresl in lhe IDA IDAC commiuee aneI
and requesled an invesligalion.

May 18: Linda LiuIe, Inseclor, CriminaI Invesligalions Division resonded lhal lhe
mauer had been referred lo lhe Washinglon IieId Oce for invesligalion.
June 23: CCHR Ied an IOIA requesl vilh lhe IDA for coies of aII records, noles,
eIeclronic in formal or olher informalion in lhe cuslody or conlroI of lhe IDA
concerning Irozac, incIuding aII aIicalions made by lhe manufaclurer, ils sludies,
and aII informalion submiued in suorl of lhe aIicalion, aII inlernaI memoranda,
reorls, Ieuers, hone caII memoranda, records elc., aII informalion given lhe IDA on
adverse reaclions reIaling lo lhe drug.

July 9: The Cenler for Drug IvaIualion and Research resonded lo lhe IOIA reIeasing
severaI lhousand ages of documenls, aIlhough lhe buIk of lhis vas made u of lhe
adverse reaclions. The olher inlernaI memoranda bareIy scralched lhe surface of
CCHRs requesl. The IDA cIaimed lhal il vas nol required by Iav lo reIease cerlain of
lhe documenls being soughl by CCHR.
July 28: CCHR aeaIed lhe IDAs deniaI of documenls, bul lhe agency faiIed lo
resond lo lhe aeaI in a limeIy manner.
August 7: CCHR received a Ieuer from Mr. }ohn I. Demsler, Direclor, ComIiance
ranch, Dearlmenl of HeaIlh & Human Services, slaling lhal in reIalion lo lhe Irozac
requesl, cerlain maleriaI has been deIeled from lhe record(s) furnished lo you.
August 21: A Los AngeIes IederaI |udge ordered GSK lo slo adverlising IaxiI as nol
habil forming.
65
GSK aeaIed and on Selember 4, lhe IDA resenled a brief lo lhe
courl in vhich il urged lhe courl lo reconsider lhe in|unclion. In }une 2003, hovever,
GSK removed roducl informalion IabeIs slaling lhal IaxiI vas nol habil-forming.
66

October: CCHR Ied a suil lo gel fuII discIosure of lhe documenls.

December 9: The NalionaI Academy of Sciences Inslilule of Medicine ubIished
lhe resuIls of ils sludy of IDA advisory commiuees and caIIed for lhe IDA lo lake
sles lo avoid conicls of inleresl associaled vilh ils advisory commiuee members.
Il referenced lhe IDAC hearing inlo Irozac and IDAC members lhal had received
$760,790 in granls from drug comanies.
67

December: The SSRI anlideressanl IaxiI inlroduced lo lhe Uniled Slales.
68

1993
March 1: The IDA changed ils Sonlaneous Reorling Syslem enlries on adverse
reaclions (ADRs) lo deIele aII medicaI reorlers commenls aboul lhe alienl. Where
once consumers couId be informed lhal a drug caused a suicidaI or vioIenl reaclion
Cn.v+i Ioi:
UsiNo Iiiuox oi INiox.+ioN
+o Acciss +ni I.c+s
in someone vilh no hislory of such behavior, lhis informalion vas lo be deIeled. Ior
examIe, a }une 20, 1991 ADR reorl shoved a 15-year-oId girI hosilaIized for an
auemled suicide (overdose) aher being on Irozac for a monlh and secied lhal she,
...did nol have a hislory of suicidaI lhoughls rior lo Irozac. Iurlher, Irozac vas
dcd |disconlinuedj and l |alienlj fuIIy recovered. Hovever, lhe same enlry aher lhe
change in lhe reorling syslem omiued lhis cruciaI informalion. The same ADR, daled
Selember 15, 1993, slaled onIy lhal lhere vas a suicide aueml and hosilaIizalion.
69

May: A sludy ubIished in lhe Journal of The American Medical Association reorled
lhal of 128 regnancies vhere lhe molher look Irozac during lhe rsl lrimesler, lhe
risk of miscarriage vas 14.8% comared lo 7.8% in molhers nol exosed lo uoxeline
or lricycIic anlideressanls. There vere 19 sonlaneous aborlions and 13 anomaIies
(abnormaIilies), incIuding hearl and smaII inlesline defecls in lhe grou vhose
molhers used Irozac. One baby vas born vilh cIubfeel, and a second vilh a congenilaI
disIocalion of lhe hi. In comarison, lhere vere 10 sonlaneous aborlions and 4
anomaIies in lhe conlroI grou.
70

May 25: CCHR Ied a comIainl vilh rian MilcheII, IrinciaI Deuly Inseclor
GeneraI of HeaIlh and Human Services aboul lhe avs in lhe IDA arovaI of Irozac
lhal CCHR had evidence of from lhe documenls il had received lhrough ils IOIA
requesl. Iurlher, lhe ADRs had reveaIed over 1,300 dealhs.
June 2: IDA Commissioner David KessIer reorled in The Journal of the American Medical
Association, AIlhough lhe IDA receives many adverse evenl reorls, lhese robabIy
reresenl onIy a fraclion of lhe serious adverse evenls encounlered by roviders....
OnIy aboul 1% of serious evenls are reorled lo lhe IDA.
71
Therefore, lhe ADRs
for Irozac vere IikeIy lo be 100 limes grealer.

July 26: CCHR vrole lo Congressman Dan Schaefer regarding lhe IDAs queslionabIe
rocedures in aroving Irozac, incIuding IDA having rior knovIedge of cIinicaI
lriaI dealhs. CCHR requesled an unbiased Iook inlo lhe mauer.

August: The IDA ADRs lhal CCHR received for Irozac belveen 1988 and Augusl
1993 reveaIed hysicians had reorled 28,564 adverse reaclions, incIuding 659 infanls
and youlhs belveen lhe ages of 1 and 18 vho suered 1,332 adverse reaclions and 34
chiIdren and adoIescenls belveen lhe ages of 5 and 18 lhal died, incIuding lvo 5-year-
oIds lhal had commiued suicide. Al Ieasl 83 chiIdren belveen lhe ages of 4 and 18 had
auemled suicide.
72
|}une 2, 1993 enlry shovs lhis olenliaIIy reresenled onIy 1% of
lhe acluaI number of ADRs.j
November 2: CCHR Ied a comIainl lo IDA Commissioner David KessIer aboul
Irozac being adverlised lhrough a usiness Wire lo lreal condilions for vhich il vas
nol IDA aroved, vioIaling federaI reguIalions for Irescrilion Drug Adverlising.
November 10: In lhe Journal of the American Medical Association, IIi LiIIy reorled
lhal lhere vas a 15.9% risk of sonlaneous aborlion in vomen laking Irozac during
regnancy and 3.4% risk of erinalaI (around birlh) maIformalions. Ils dalabase
recorded 1,103 vomen laking Irozac during regnancy.
73

December 13: CCHR Ied a comIainl vilh lhe Inseclor GeneraI of lhe Del of
HeaIlh and Human Services aIong vilh an anaIysis of lhe adverse reaclions of Irozac,
requesling aclion lo be laken againsl lhe IDAs faiIure lo rolecl consumers.
74

1994
During lhe year, Izer aid for lhe deveIomenl of Irime MD, a checkIisl of
symloms based on lhe DSM lhal hysicians checked o lo suosedIy idenlify
anxiely, deression, subslance abuse and olher disorders in order lo make a diagnosis
in an average of 8 minules. Irofessors Herb Kulchins and Sluarl A. Kirk, aulhor of
Making Us Crazy, caIIed il lhe AIaskan ieIine for lhe harmaceulicaIs, a melhod of
gaining direcl access lo an immense nev markel.
75
The fourlh edilion of lhe DSM
vas reIeased vilh an emhasis on a bioIogicaI basis for menlaI disorders, desile no
evidence lo suorl lhis, making il easier for drugs lo be aroved for lrealmenl of
lhem. Yel, DSM-IV conlained lhis Caulionary Slalemenl lo conceaI lhe facl lhal lhe
1,000 exerls used in lhe deveIomenl of lhe manuaI couId nol dene vhal a menlaI
disorder is and couId nol rovide scienlic suorl for one: The secic diagnoslic
crileria for each menlaI disorder are oered as guideIines for making diagnoses,
because il has been demonslraled lhal lhe use of such crileria enhances agreemenl
among cIinicians and invesligalorsThese diagnoslic crileriareecl a consensus of
currenl formuIalions of evoIving knovIedge in our eId. In olher vords, il vas a
consensus of oinions, nol medicaI facl.
76

A sludy by Dr. David HeaIy of lhe Dearlmenl of IsychoIogicaI Medicine, Norlh
WaIes HosilaI, enlilIed, The IIuoxeline and Suicide Conlroversy: A Reviev of lhe
Ividence conrmed lhal Irozac may Iead lo lhe emergence of suicidaI idealion.
77

January 14: The Inseclor GeneraI of HeaIlh and Human Services resonded lo
CCHR slaling lhal il did nol have lhe exerlise lo invesligale lhe IDA.
78
Inslead, lhe
comIainl vas referred lo Dr. Roberl TemIe, Direclor of lhe Oce of lhe IDAs Drug
IvaIualion and one of lhe ociaIs, vho had aIready endorsed lhe Selember 20, 1991
IDAC hearing ndings lhal lhere vas nolhing vrong vilh Irozac and vas one of lhe
originaI IDA members lhal originally approved Prozac for the market as safe. |See Oclober
3, 1991 enlry.j
March 15: Dr. TemIes resonse lo CCHR mereIy reileraled lhal lhere vas
nolhing vrong vilh Irozac.
79

March 26: IDA Safely Reviever, Andrev MoshoIder, M.D., resenled evidence lo lhe
IDA IDAC hearing inlo Irozac lhal during lhe cIinicaI lriaIs of a drug for buIimia
(an ealing disorder) 7 people died, 4 by suicide. No aulosies vere conducled in lhe
IIi LiIIy-conlroIIed sludies. In lheir ackage informalion for Irozac, lhe manufaclurer
reorled lhal 9% of alienls during lhe cIinicaI lriaIs deveIoed anorexia. In a Nev
Drug AIicalion reorl oblained under lhe Ireedom of Informalion Acl, lhis side
eecl vas noled as signicanl. According lo lhe ADRs, al Ieasl 20 chiIdren suered
anorexia or veighl Ioss, vilh lhe ma|orily of lhese aged belveen 13 and 18. Desile
lhis, lhe IDAC recommended lhal Irozac be aroved for lhe lrealmenl of buIimia.
80

May: CCHR roduced a While Iaer lilIed CHILD AUSI WITH IROZAC lhal
oulIined lhe ADRs shoving chiIdren auemling or commiuing suicide vhiIe laking
Irozac and lhal lhe drug shouId nol be aroved for edialric use. This vas senl lo
lhe IDA and various CongressionaI commiuees. Iurlher, il reorled lhal lhe IDA
had received ADRs shoving birlh defecls in babies born lo vomen laking Irozac
during regnancy. There vere 17 reorls of babies being born vilh a congenilaI
anomaIy (abnormaIilies). Of lhese, 2 died and 13 vere hosilaIized. There vere
four infanl dealhs in reIalion lo Irozac vhere lhe molher had eilher laken Irozac
during or before regnancy: 1 vas sliIIborn, a 6-monlh-oId died aher having been
remalureIy born and 2 died from congenilaI deformilies. Anolher 4-monlh-oId baby
vas reorled as suering drug deendence, dyslonia (movemenl disorder), overdose
and convuIsions. A nevborn suered drug vilhdravaI symloms vilhin 24 hours
of deIivery.

May: The AIA udaled ils Diagnostic and Statistical Manual, adding 21 nev menlaI
disorders bringing lhe lolaI lo 374a goIdmine of nev disorders for vhich nev
sychialric drugs couId be deveIoed. y 1994, lhere vere 32 chiIdhood sychialric
disorders for vhich anlideressanls, slimuIanls and anlisycholics couId be
rescribed. The DSM-IV Iisled 1,000 consuIlanls lhal couId nol agree on a denilive
denilion of menlaI disorder.
81

May 20: In lhe Psychiatric News, DonaId KIein, rofessor of sychialry al CoIumbia
Universily commenled on lhe Iack of sludies inlo lhe olenliaIIy damaging eecls of
anlideressanls in lhe Irozac grou, slaling, I lhink lhe induslry is concerned aboul
lhe ossibiIily of nding Iong-lerm risks.
82

December: Tvenly-seven survivors of }oseh Wesbeckers kiIIing ramage and famiIy
members of his deceased viclims sued IIi LiIIy conlending lhal il knev aboul lhe
roensily for Irozac lo cause vioIence. This gave auorneys and exerls access lo LiIIys
inlernaI memos. Wilh 150 Iavsuils Ied by 1994 in reIalion lo lhe anlideressanl,
lhe Wesbecker lriaI vas cruciaI for IIi LiIIy lo vin. IIainlis argued lhal lhere vas
a hislory of reckIess disregard lovard consumers, arlicuIarIy aboul anolher drug
Oraex lhal had Ied lo 100 dealhs. (Oraex vas laken o lhe markel and IIi LiIIy
Ied guiIly lo 25 counls of misIabeIing side eecls.) The comany did nol vanl lhe
inlernaI records invoIving Oraex made ubIic during lhe Wesbecker lriaI.
83
LiIIy von
lhe case, bul vas Ialer forced lo admil lhal il had made a secrel seuIemenl vilh lhe
Iainlis during lhe lriaI, vhich meanl lhe verdicl vas invaIid.
84
The |udge in lhe lriaI
foughl for an invesligalion and in 1997, LiIIy agreed lo a verdicl being changed from
a viclory lo dismissed as seuIed.
85
The sychialrisl lhal had lrealed Wesbecker had
sohened his earIier leslimony lo lhe Coroner Iinking Irozac lo his behavior, aher he
had been aroached lo reviev LiIIys ovn maleriaIhighIighled lo emhasize lheir
vievsfor vhich he vas aid $200 an hour.
86

1995
IMS America reorled lhal lhe number of limes doclors in lhe U.S. recommended
rescribed or reIIed rescrilions for Irozac for chiIdren ages 6 lo 12 doubIed from
1995 lo 1996. Commenling on lhe massive increase lhree years Ialer, Dr. Thomas
Laughren from lhe IDAs sychialric drug roduclions division vas unconcerned,
Ils onIy aIarming in lhe sense lhal ils a raclice lhals ongoing in lhe absence of
research dala lo suorl lhe use of anlideressanls in chiIdren. Laughren vas arl
of an IDA grou vorking on ruIes lhal vouId require manufaclurers lo conduct more
studies into the eects of drugs like Prozac on children.
87
|See May 1994 enlry on lhe DSM
and incIusion of chiIdhood menlaI disorders.j elveen 1995 and 1999, lhe use of
anlideressanls vouId increase 580% in lhe under 6 ouIalion and 151% in lhe 7-12
age grou.
88
More medicaI sludies vere ubIished conrming lhe vioIence/suicide Iinks lo SSRI
anlideressanls. Nine AuslraIian sychialrisls reorled lhal alienls had sIashed
lhemseIves or become reoccuied vilh vioIence vhiIe laking SSRIs. I didnl vanl
lo die, I |usl feIl Iike learing my esh lo ieces, one alienl loId lhe sychialrisls.
89
In
Lancet, lhe rilish medicaI |ournaI, Dr. Miki Ioch reorled on alienls vho became
suicidaI and homicidaI aher sloing an anlideressanl, vilh one man having lhoughls
of harming his ovn chiIdren.
A sludy, Anlideressanls and Suicide by Dr. HersheI }ick, delermined, The resuIls
indicale lhal onIy uoxeline |Irozacj has a rale |of suicidej lhal seems lo be subslanliaIIy
higher lhan lhal of olher anlideressanls.
90

August: A sludy by Dr. }un|i Ichikava al Case Weslern Research Universily SchooI
of Medicine and ubIished in lhe European Journal of Pharmacology, reorled lhal
Irozac roduced a 57% dro in doamine |chemicaI/hormonej in lhe invoIunlary
molor syslem. oosled beyond ordinary IeveIs, eIevaled serolonin couId lrigger a
dangerous backIash, a comensalory dro in doamine, resuIling in lhe drugs mosl
severe neuroIogicaI side eecls. This is Iike squeezing one end of a baIIoon onIy lo
have il o oul eIsevhere. Of course, lhis kind of secondary, indirecl eecl on olher
neurolransmiuers renders lhe drugs nol seIeclive al aII.
91

1996
Al a drug comany-funded cIosed-door conference, lhe vilhdravaI eecls from lhe
SSRIs vere renamed as anlideressanl disconlinualion syndrome lo avoid lhe
negalive connolalions of addiclion.
92
Isychialrisls began using lhe lerm in medicaI
aers and lo alienls. In lhe foIIoving year, lhe grou of exerls lhal auended
lhis symosium ubIished eighl aers markeling anlideressanl disconlinualion
syndrome.
93

An IDA memo raised lhe ossibiIily lhal ZoIoh mighl cause chiIdren and leenagers
lo become suicidaI.
94
IDA researcher Dr. }ames I. Knudsen vrole lo an execulive al
Izer lhal lhere aears lo be an increased frequency of reorls of suicidaIily in lhe
edialric/adoIescenl alienls exosed lo ZoIoh in cIinicaI lriaIs.
95

Cn.v+i Iivi:
CoviiNo Uv Wi+nu.w.i Svxv+oxs
1997
The IDA aroved lhe anlideressanl Luvox for chiIdren diagnosed vilh Obsessive
ComuIsive Disorder. Yel during lhe cIinicaI lriaIs for lhe drug, 4% of lhose laking
Luvox deveIoed mania, described as a form of sychosis characlerized by exaIled
feeIings, deIusions of grandeurand overroduclion of ideas.
96
|See AriI 1999
enlry, CoIumbine schooI massacre.j
InlernaI GIaxoSmilhKIine documenls (reveaIed ubIicIy in 2004) shoved lhal in
some cIinicaI sludies, lhe number of eoIe laking IaxiI vho exerienced withdrawal
symloms vas as high as 42%. Documenls direcled saIes res lo minimize concerns
aboul disconlinualion and lo avoid using lhe vord vilhdravaI. Iorced lo
leslify before Congress in Oclober 2004, manufaclurer reresenlalives admiued lheir
ovn sludies shoved as many as 25% of eoIe laking IaxiI exerience vilhdravaI
symloms. Yel lhe drug ackaging onIy reorled a risk of 2%.
97

The IDA aroved Direcl lo Consumer markeling (TV, Magazine ads, elc.) lhal
dramalicaIIy inuenced rescrilion lrends and drug saIes. Isycholroic drug
rescrilions for adoIescenls aged 14 lo 18 years increased by 250% belveen 1994 (re
DTC) and 2001, vilh lhe buIk of lhe increase from 1999 onvard.
98
The money lhal
venl lo DTC adverlising vouId be slaggering, rising from $791 miIIion in 1996 lo $2.4
biIIion in 2000 and $4 biIIion in 2004.
99

November: In lhe Archives of General Psychiatry, Levis }udd of lhe dearlmenl
of sychialry al lhe Universily of CaIifornia and asl direclor of NIMH, described
deression as a disease of lhe brain, forvarding lhe sychialric-harmaceulicaI
markeling Iine lhal vouId convince miIIions lo lake mind-aIlering drugs lo correcl
chemicaI imbaIances in lhe brain lhal simIy didnl exisl.
100

1998
Minnesola sychialrisl Irank Abuzzhab, a Iead invesligalor in one of four Iacebo
conlroIIed sludies for Irozac lhal LiIIy submiued lo lhe IDA lo vin arovaI, vas
found guiIly by lhe Minnesola oard of MedicaI Iraclice of reckIessIy enlering
alienls inlo sychialric drug lriaIs, faIsifying lheir records, and fabricaling osilive
drug resonses in an invesligalion. He vouId caII lhe alienls diagnosis one lhing in
lhe charl, lhen ul lhe erson on a drug and change lhe diagnosis lo l lhe crileria for
lhe sludy.
101

1998-2002: SmilhKIine eecham, nov GIaxoSmilhKIine, conducled cIinicaI lriaIs for
ils SSRI anlideressanl, IaxiI. Sludies of more lhan 1,000 alienls under lhe age of
18 shoved lhal 3.4% of lhose laking IaxiI or recenlIy sloed, had auemled suicide
or lhoughl more aboul il. Thal comared vilh 1.2% of lhe chiIdren vho vere laking
Iacebo.
102

An inlernaI GSK documenl from 1998 (made ubIic in 2004) concIuded lhal, in Iighl of
lhe mixed ecacy oulcomes from one sludy, No. 329, and lhe enlireIy negalive resuIls
of anolher sludy No. 377, GSKs largel vas l|oj eecliveIy manage lhe disseminalion
of lhese dala in order to minimize any potential negative commercial impact. 3
October: CCHR began vriling a series of ubIicalions and reorling on ils vebsile
lhal lhe anlideressanl markeling cIaim lhal lhe drugs correcled a chemicaI imbaIance
in lhe brain vas frauduIenl and misIeading lo consumers. The bookIels, vhich by
2004 comrised 20 issues, aIso exosed lhe dangers sychialric drugs osed, lhe
misinformalion sychialrisls vere sreading aboul lhe eecliveness of lhese drugs
and ciled many medicaI exerls lhal debunked lhe chemicaI imbaIance lheory.
November 16-18: The NalionaI Inslilules of HeaIlh heId a lvo-day hearing inlo
lhe vaIidily of Auenlion Decil Hyeraclivily Disorder (ADHD), vhich vas being
romoled as a neurobioIogicaI disorder. CCHR and medicaI exerls sav lhis as yel
anolher examIe of harmaceulicaI-sychialric faIse markeling lo seII drugs, simiIar
lo lhe chemicaI imbaIance lheory invenled lo seII SSRI anlideressanls. CCHR and
exerls leslied lo lhis eecl during lhe hearing. NIHs concIuded, We donl have an
indeendenl, vaIid lesl for ADHD, lhere are no dala lo indicale lhal ADHD is due lo
a brain maIfunclionand naIIy, aher years of cIinicaI research and exerience vilh
ADHD, our knovIedge aboul lhe cause or causes of ADHD remains secuIalive.
103
NIH aneI member Mark Vonnegul, M.D. slaled: The diagnosis is a mess.
104
Desile
lhis, lhe IDA conlinued lo aIIov slimuIanl manufaclurers lo adverlise lhal ADHD vas
a neurobioIogicaI condilion.
Between 1988 when Prozac was approved and 2006, there were 46 incidents of school violence
involving 48 children and adolescents. Of these, 38% were reported in media, websites or books
to be taking psychiatric drugs or were withdrawing from them at the time of their shooting
spree. The relationship of psychiatric drugs in the remaining incidents of violence has not
been publicly disclosed or the persons records are sealed. Frequently, antidepressants were
implicated.
1999
April: In Idaho, 15-year-oId Shavn Cooer red lvo sholgun rounds in his schooI,
narrovIy missing sludenls. He vas laking a rescribed SSRI anlideressanl and
RilaIin.
April: Iric Harris and DyIan KIeboId venl on a shooling sree in lheir CoIumbine,
CoIorado schooI, kiIIing 13 and vounding 23. CCHR and olhers ressured lo have
lhe Coroner re-lesl lhe leens bIood for sychialric drugs. The Coroner subsequenlIy
conrmed lhal Harris bIood conlained a lheraeulic dose of lhe SSRI anlideressanl,
Luvox. CIinicaI lriaIs shoved lhal 4% of chiIdren laking lhe drug exerienced mania,
a condilion knovn lo resuIl in vioIenl behavior. CoIorado Slale Re. Ienn Iner,
chaired a hearing on lhe ossibIe conneclion of vioIenl behavior and sycholroic
drugs, slaling, There is enough coincidence and enough rofessionaI oinion from
Iegilimale scienlisls lo cause us lo raise lhe issue and lo ask furlher queslions. If
vere onIy inleresled in debaling gun Iavs and melaI deleclors, said Iner, lhen
ve as IegisIalors arenl doing our |ob.
105

May: CCHR roduced a While Iaer Psychiatry and The Creation of Senseless Violence
delaiIing examIes of sychialric-drug induced crime and medicaI sludies roving
lhal such drugs reciilale murderous acls. More lhan 10,000 coies of lhe reorl
vere dislribuled lo IegisIalors, educalors and media in lhe U.S.
May: KeIIy Ialricia OMeara, a former CongressionaI sla vho vas vriling for
Washington Times Insight Magazine vrole a slory based on CCHRs and her ovn
research, lilIed Guns and Doses. Il shoved lhe common Iink belveen high-schooI
shoolings and sychialric drugs.
June: The nalionaI TV shov 20/20 ran a slory on lhe dangers of anlideressanls
and hov lhe science behind lhe sludies shoving lheir safely vas inaccurale and
misreresenled. A foIIov-u rogram on anlideressanl vilhdravaI conrmed SSRI
anlideressanls vere olenliaIIy addiclive, vilh severe vilhdravaI eecls.
July: IennsyIvania Slale Reresenlalive LeAnna Washinglon heId a Hearing inlo
Isychialric Drugs and Their Iecls on ChiIdren al vhich CCHR leslied aboul lhe
vioIence-inducing nalure of lhese drugs.
July: The IDA aroved reackaged version of Irozac caIIed Sarafem lo lreal
remenslruaI dyshoric disorder (IMDD), vas rolecled unliI 2007. The IDA had
aroved Sarafem for a condilion lhal didnl even exisl in lhe DSM.
106
LiIIy agreed lo
ay $90 miIIion for lhis alenled nev Irozac moIecuIe lo reduce cerlain side eecls of lhe
originaI Irozac, incIuding nervousness, anxiely, insomnia, inner reslIessness, suicidaI
lhoughls, seIf-muliIalion and manic behavior.
107
|See December 18, 2003 enlryj
Cn.v+i Six:
Isvcni.+ic Dios C.isi
Scnooi VioiiNci s Di.+n
August: The NalionaI Ioundalion of Women LegisIalors annuaI congress vas heId in
Los AngeIes vhere CCHR resenled a round-labIe conference on sychialric drugs
and vioIence. Coies of CCHRs Psychiatry and the Creation of Senseless Violence reorl
vere dislribuled lo IegisIalors.
October: CCHR, aIong vilh medicaI exerls and educalors leslied before a hearing
of lhe CoIorado Slale oard of Iducalion, roviding evidence and medicaI sludies on
sychialric drugs and vioIence, eseciaIIy in reIalion lo schooI shoolings.
October 4: The Boston Globe reorled lhal Dr. Marlin KeIIer, rofessor and chairman of
lhe dearlmenl of sychialry al rovn Universily, had numerous arlicIes advocaling
Iong-lerm use of anlideressanlseseciaIIy ZoIohubIished in medicaI |ournaIs.
WhiIe aearing lo be imarliaI, KeIIer had earned $842,000 in 1998, more lhan haIf
of vhich vas from harmaceulicaI comanies. He received $218,000 from ZoIohs
manufaclurer.
108
November 9: Resonding lo CCHRs reorl, Psychiatry and the Creation of Senseless
Violence, a CoIorado slale IegisIalor organized an Ad hoc governmenl hearing inlo
sychialric drugs and vioIence. CCHR and medicaI exerls resenled evidence on
lhis.
November 11: The CoIorado Slale oard of Iducalion assed a ResoIulion caIIing for
leachers lo use academic soIulions for behavioraI and educalionaI robIems in lhe
cIassroom inslead of sychialric drugs. The oard recognized lhal lhere are documenled
incidences of highIy negalive consequences in vhich sychialric rescrilion drugs
have been uliIized for vhal are essenliaIIy robIems of disciIine....
November 4: Dr. David HeaIy vrole lo lhe UK Medicines ConlroI Agency |IDA
equivaIenlj aboul lhe risk of suicide in eoIe laking Irozac.
109

December: CCHR resenled ils evidence on sycholroic drugs and vioIence lo lhe
NalionaI Caucus of Iack Slale LegisIalors lhal assed a resoIulion caIIing for a federaI
invesligalion inlo lhe use of lhese drugs in chiIdren.
2000
The American Journal of Epidemiology ubIished lvo sludies lhal demonslraled lhal
IaxiI resenled a 720% increase in risk of breasl cancer in femaIes.
110

February: The AuslraIian Theraeulic Goods Adminislralion (TGA) ubIished an
Adverse Drug Reaclions uIIelin reorling lhal sychialric drugs cause nighlmares
and secicaIIy menlioned Irozac, ZoIoh, IaxiI and CeIexa.
111

March 1: Mauhev Smilh, aged 14, died of a hearl auack aher being rescribed RilaIin
for severaI years. A Michigan coroner delermined lhal his hearl shoved cIear signs of
lhe smaII bIood vesseI damage caused by slimuIanls, concIuding lhal he had died from
lhe Iong-lerm use of RilaIin. Mauhev vas forced onlo lhe drug lhrough his schooI,
vilh lhe arenls lhrealened vilh charges of medicaI and educalion negIecl if lhey
refused lo ul him on lhe drug.
112
Isychialrisls al lhe lime dismissed lhe coroners
ndings. |See }anuary 5, 2006 enlry on varnings lhe IDA evenluaIIy issued, more lhan
40 years aher RilaIin had been on lhe markel.j
Between 1988 when Prozac was approved and 2006, there were 46 incidents of school violence
involving 48 children and adolescents. Of these, 38% were reported in media, websites or books
to be taking psychiatric drugs or were withdrawing from them at the time of their shooting
spree. The relationship of psychiatric drugs in the remaining incidents of violence has not
been publicly disclosed or the persons records are sealed. Frequently, antidepressants were
implicated.
1999
April: In Idaho, 15-year-oId Shavn Cooer red lvo sholgun rounds in his schooI,
narrovIy missing sludenls. He vas laking a rescribed SSRI anlideressanl and
RilaIin.
April: Iric Harris and DyIan KIeboId venl on a shooling sree in lheir CoIumbine,
CoIorado schooI, kiIIing 13 and vounding 23. CCHR and olhers ressured lo have
lhe Coroner re-lesl lhe leens bIood for sychialric drugs. The Coroner subsequenlIy
conrmed lhal Harris bIood conlained a lheraeulic dose of lhe SSRI anlideressanl,
Luvox. CIinicaI lriaIs shoved lhal 4% of chiIdren laking lhe drug exerienced mania,
a condilion knovn lo resuIl in vioIenl behavior. CoIorado Slale Re. Ienn Iner,
chaired a hearing on lhe ossibIe conneclion of vioIenl behavior and sycholroic
drugs, slaling, There is enough coincidence and enough rofessionaI oinion from
Iegilimale scienlisls lo cause us lo raise lhe issue and lo ask furlher queslions. If
vere onIy inleresled in debaling gun Iavs and melaI deleclors, said Iner, lhen
ve as IegisIalors arenl doing our |ob.
105

May: CCHR roduced a While Iaer Psychiatry and The Creation of Senseless Violence
delaiIing examIes of sychialric-drug induced crime and medicaI sludies roving
lhal such drugs reciilale murderous acls. More lhan 10,000 coies of lhe reorl
vere dislribuled lo IegisIalors, educalors and media in lhe U.S.
May: KeIIy Ialricia OMeara, a former CongressionaI sla vho vas vriling for
Washington Times Insight Magazine vrole a slory based on CCHRs and her ovn
research, lilIed Guns and Doses. Il shoved lhe common Iink belveen high-schooI
shoolings and sychialric drugs.
June: The nalionaI TV shov 20/20 ran a slory on lhe dangers of anlideressanls
and hov lhe science behind lhe sludies shoving lheir safely vas inaccurale and
misreresenled. A foIIov-u rogram on anlideressanl vilhdravaI conrmed SSRI
anlideressanls vere olenliaIIy addiclive, vilh severe vilhdravaI eecls.
July: IennsyIvania Slale Reresenlalive LeAnna Washinglon heId a Hearing inlo
Isychialric Drugs and Their Iecls on ChiIdren al vhich CCHR leslied aboul lhe
vioIence-inducing nalure of lhese drugs.
July: The IDA aroved reackaged version of Irozac caIIed Sarafem lo lreal
remenslruaI dyshoric disorder (IMDD), vas rolecled unliI 2007. The IDA had
aroved Sarafem for a condilion lhal didnl even exisl in lhe DSM.
106
LiIIy agreed lo
ay $90 miIIion for lhis alenled nev Irozac moIecuIe lo reduce cerlain side eecls of lhe
originaI Irozac, incIuding nervousness, anxiely, insomnia, inner reslIessness, suicidaI
lhoughls, seIf-muliIalion and manic behavior.
107
|See December 18, 2003 enlryj
August 19: A suil vas Ied in San }ose, CaIifornia under lhe usiness and Irofessions
Code aIIeging lhal GIaxoSmilhKIine had faiIed lo varn lhe ubIic aboul lhe dangers of
IaxiI vilhdravaI eecls. GSK resoIved lhe suil in }anuary 2002, lhe resuIls, incIuding
any seuIemenl by GSK, vere nol announced.
113

An anaIysis of nev anlisycholic drugs (IDA aroved onIy a fev years earIier)
invoIving 12,000 alienls found no cIear evidence lhal alyicaI |nevj anlisycholics
are more eeclive or are beuer loIeraled lhan convenlionaI anlisycholics. Dr. }ohn
Geddes from Oxford Universily revieved 52 indeendenl cIinicaI lriaIs in a sludy
aid for by lhe rilish governmenl vilh lhe resuIls ubIished in The British Medical
Journal.
114
September 29: A U.S. House Iducalion Subcommiuee heId a hearing on sychialric
drug use in chiIdren. CCHR vorked vilh arenls and medicaI exerls vho
leslied before lhe Subcommiuee. One arenl, Mrs. Ialricia Wealhers, leslied lhal
anlideressanls made her son sycholic.
2001
February 14: The IDA naIIy issued a varning aboul IaxiIs vilhdravaI eecls,
incIuding dizziness, sensory dislurbances (e.g., eIeclric shock sensalions), agilalion,
anxiely, nausea and svealingSimiIar evenls have been reorled for olher seIeclive
serolonin reulake inhibilors.
115
April 4: Dr. HeaIy vrole again lo lhe UK Medicines ConlroI Agency aboul evidence
of anlideressanls, in arlicuIar IaxiI and ZoIoh, causing suicide.
116
Dr. }oseh GIenmuIIen, Harvard MedicaI SchooI sychialrisl, ubIished Prozac Backlash,
exosing lhe dangerous eecls of SSRI anlideressanls, slaling: In recenl years, lhe
danger of Iong-lerm side eecls emerged in associalion vilh Irozac-lye drugs,
making il imeralive lo minimize ones exosure lo lhem. NeuroIogicaI disorders
incIuding disguring faciaI and vhoIe body lics, indicaling olenliaI brain damage,
are an increasing concern vilh alienls on drugs.
117
WilhdravaI syndromes vere
eslimaled lo aecl u lo 50% of alienls, sexuaI dysfunclion aecled 60%, adding,
Here is evidence lhal lhey may aecl a chemicaI Iobolomy by deslroying lhe nerve
endings in lhe brain.
118

May 25: An AuslraIian |udge bIamed an SSRI for lurning a eacefuI, Iav abiding
man, David Havkins, inlo a vioIenl kiIIer. }udge arry OKeefe of lhe Nev Soulh
WaIes Sureme Courl said lhal had Mr. Havkins nol laken lhe anlideressanl, il is
overvheImingIy robabIe lhal Mrs. Havkins vouId nol have been kiIIed.

June: A Wyoming |ury avarded $8 miIIion lo lhe reIalives of a man, DonaId ScheII,
vho venl on a shooling ramage aher laking IaxiI and kiIIed his vife, daughler,
granddaughler and himseIf. The |ury delermined lhal lhe drug vas 80% resonsibIe
for lhe kiIIing sree.
June: The C in lhe UK ran an exose on IaxiI causing addiclion and vilhdravaI
symloms. Dr. HeaIy reorled lhal cIinicaI drug lriaIs shoved lhal heaIlhy sub|ecls
suered vilhdravaI symloms aher onIy laking lhe drug for a fev veeks.
119

August: The alenl for Irozac exired.
120

August: Dr. Irank }. Ayd, lhe sychoharmacoIogisl lhal heIed deveIo neuroIelics
(anlisycholic drugs) in lhe 1950s and 60s, resenled ndings of his reviev of
Iileralure for alyicaI (nev) anlisycholics. He delermined lhal lhere vas a slarlIing
associalion belveen inilialion of lrealmenl vilh IIi LiIIys Zyrexa and nev-onsel of
diabeles in adoIescenls.
121

November: Researchers al lhe IDAs Cenler for Drug IvaIualion Cenler and Dr. I.
MauraIi Doraisevamy of Duke Universily conrmed Dr. Ayds ndings lhal lhere
vas a causaI associalion belveen Zyrexa and diabeles10 limes higher lhan in lhe
generaI ouIalion.
122

December 14: GIaxoSmilhKIine and lhe IDA slrenglhened IaxiIs IabeI in regard lo
vilhdravaI eecls, hovever using lhe drug induslry-invenled lerm disconlinualion
syndrome inslead of lhe negalive connolalion, withdrawal. In lhe Irecaulions seclion
of lhe nev IabeI, GSK ciled cIinicaI lriaI dala conrming lhe exislence of severaI
vilhdravaI symloms, incIuding abnormaI dreams, areslhesia (abnormaI sensalions,
eIeclric shock sensalions), and dizziness, agilalion, anxiely, nausea and svealing.
123

August 19: A suil vas Ied in San }ose, CaIifornia under lhe usiness and Irofessions
Code aIIeging lhal GIaxoSmilhKIine had faiIed lo varn lhe ubIic aboul lhe dangers of
IaxiI vilhdravaI eecls. GSK resoIved lhe suil in }anuary 2002, lhe resuIls, incIuding
any seuIemenl by GSK, vere nol announced.
113

An anaIysis of nev anlisycholic drugs (IDA aroved onIy a fev years earIier)
invoIving 12,000 alienls found no cIear evidence lhal alyicaI |nevj anlisycholics
are more eeclive or are beuer loIeraled lhan convenlionaI anlisycholics. Dr. }ohn
Geddes from Oxford Universily revieved 52 indeendenl cIinicaI lriaIs in a sludy
aid for by lhe rilish governmenl vilh lhe resuIls ubIished in The British Medical
Journal.
114
September 29: A U.S. House Iducalion Subcommiuee heId a hearing on sychialric
drug use in chiIdren. CCHR vorked vilh arenls and medicaI exerls vho
leslied before lhe Subcommiuee. One arenl, Mrs. Ialricia Wealhers, leslied lhal
anlideressanls made her son sycholic.
2001
February 14: The IDA naIIy issued a varning aboul IaxiIs vilhdravaI eecls,
incIuding dizziness, sensory dislurbances (e.g., eIeclric shock sensalions), agilalion,
anxiely, nausea and svealingSimiIar evenls have been reorled for olher seIeclive
serolonin reulake inhibilors.
115
April 4: Dr. HeaIy vrole again lo lhe UK Medicines ConlroI Agency aboul evidence
of anlideressanls, in arlicuIar IaxiI and ZoIoh, causing suicide.
116
Dr. }oseh GIenmuIIen, Harvard MedicaI SchooI sychialrisl, ubIished Prozac Backlash,
exosing lhe dangerous eecls of SSRI anlideressanls, slaling: In recenl years, lhe
danger of Iong-lerm side eecls emerged in associalion vilh Irozac-lye drugs,
making il imeralive lo minimize ones exosure lo lhem. NeuroIogicaI disorders
incIuding disguring faciaI and vhoIe body lics, indicaling olenliaI brain damage,
are an increasing concern vilh alienls on drugs.
117
WilhdravaI syndromes vere
eslimaled lo aecl u lo 50% of alienls, sexuaI dysfunclion aecled 60%, adding,
Here is evidence lhal lhey may aecl a chemicaI Iobolomy by deslroying lhe nerve
endings in lhe brain.
118

May 25: An AuslraIian |udge bIamed an SSRI for lurning a eacefuI, Iav abiding
man, David Havkins, inlo a vioIenl kiIIer. }udge arry OKeefe of lhe Nev Soulh
WaIes Sureme Courl said lhal had Mr. Havkins nol laken lhe anlideressanl, il is
overvheImingIy robabIe lhal Mrs. Havkins vouId nol have been kiIIed.

June: A Wyoming |ury avarded $8 miIIion lo lhe reIalives of a man, DonaId ScheII,
vho venl on a shooling ramage aher laking IaxiI and kiIIed his vife, daughler,
granddaughler and himseIf. The |ury delermined lhal lhe drug vas 80% resonsibIe
for lhe kiIIing sree.
June: The C in lhe UK ran an exose on IaxiI causing addiclion and vilhdravaI
symloms. Dr. HeaIy reorled lhal cIinicaI drug lriaIs shoved lhal heaIlhy sub|ecls
suered vilhdravaI symloms aher onIy laking lhe drug for a fev veeks.
119

2002
May: An IDA ociaI Dr. Andrev MoshoIder revieved informalion GIaxoSmilhKIine
had reviousIy submiued lo lhe IDA for arovaI of IaxiI and noled lhal chiIdren
given lhe drug suered more emolionaI IabiIily (vuInerabiIily) lhan lhose given
Iacebos.
124
He rovided his reviev lo lhe IDA vho vouId nol aIIov him lo reIease
il. SeveraI years Ialer Dr. MoshoIder bIovs lhe vhislIe on lhe dangers of lhese drugs.
May: InlernalionaI media ran on a sludy by Slanford Universily hysician RandaII
Slaord lhal found lhal desile lhousands of sludies, hundreds of miIIions of
rescrilions and lens of biIIions of doIIars in drug saIes, sugar iIIs vere |usl as eeclive
as or even beuer lhan anlideressanls. SeauIe sychialrisl Arif Khan aIso revieved 96
anlideressanl lriaIs belveen 1979 and 1996, nding lhal in 52% of lhem, lhe eecl of
lhe anlideressanl couId nol be dislinguished from lhal of Iacebo. Andrev Leuchler,
a rofessor of sychialry al UCLA commenled, We have lhis faIIacy of success, bul
ve donl knov in any individuaI vhy lhey gel beuer.
125

June 3: ArlicIe in lhe Washington Times Insight Magazine, lilIed Money and Madness
reorled hov lhe AIA, NalionaI Inslilule of MenlaI HeaIlh vere asked hov many
disorders lhal are Iisled in lhe DSM-IV are curabIe, vhal documenled diagnoslic,
hysicaI abnormaIily had been found in schizohrenia, ADHD and deression. And
vhal diagnoslic lesls vere avaiIabIe and uliIized lo delecl a chemicaI imbaIance`
The AIA vouId nol resond and NIMH referred lhe |ournaIisl lo lhe U.S. Surgeon
GeneraIs 1999 reorl on menlaI heaIlh. This reorl, vhiIe cIaiming lhal menlaI
iIInesses accounled for 15% of lhe overaII burden of disease in lhe counlry, lhere vas
no menlion of any diagnoslic lesl or hysicaI roof lo conrm lhis.
126

October 13: In rilain, lhe C aired lhe resuIls of ils invesligalion inlo vhal il caIIed
The Secrels of Seroxal IaxiI, shoving sychialrisls had knovn aII aIong lhal eoIe
couId gel hooked on lhe anlideressanl. They couId aIso suer serious vilhdravaI
symloms.

September 2: CCHR leslied before lhe U.S. Governmenl Reform Commiuee inquiry
inlo Over-Diagnosis of Auenlion Decil Hyeraclivily DisordersAre We Over-
Medicaling Our ChiIdren` and caIIed for nalionaI and slale IegisIalion lo slo chiIdren
being forced onlo slimuIanls and anlideressanls in schooIs. They rovided slalislics
on schooI vioIence Iinked lo sychialric drugs.
September: UnliI his resignalion in Iale 2004, IDA Chief CounseI, DanieI Troy vas
anolher defender of lhe harmaceulicaI induslry, Iing IegaI briefs on behaIf of his
former cIienls such as Izer, Inc. (maker of ZoIoh). In 2002, Izer conlacled Troy
requesling lhe governmenl gel invoIved in a rivale Iavsuil, arguing lhal, even
lhough Izer never soughl lo slrenglhen ZoIohs varning IabeI concerning suicidaIily,
any varning, no mauer hov vorded, suggesling a Iink belveen ZoIoh and suicidaIily
vouId have been faIse and misIeading, vouId have misbranded lhe drug, and lhe IDA
vouId have re|ecled any eorl by Izer lo use such a varning. Troys brief cIaimed
lhal Izer vouId have been IiabIe for ubIishing a IabeI lhal vas faIse and misIeading
if il had issued lhe varning advocaled by lhe Iainli in lhal case.
127

October: A sludy conducled by Arif Khan, medicaI direclor of lhe Norlhvesl CIinicaI
Research Cenler in eIIevue, Washinglon and ad|uncl rofessor of sychialry al Duke
Cn.v+i 7:
Wnis+iiniowis Svi.x Oi+
Universily SchooI of Medicine, reveaIed slarlIing numbers of suicides commiued and
suicides auemled in lhe cIinicaI lriaIs for SSRI anlideressanlsnumbers lhal for
years had been hidden. Ixamining lhe cIinicaI lriaI dala lhal had been resenled lo
lhe IDA, Kahn found vhiIe eoIe vilh a hislory of suicide are excIuded lhal nearIy
4% of SSRI drug-lriaI arlicianls auemled suicide vilhin lhe foIIoving year. The
IDAs Thomas Laughren negaled lhe ndings as irreIevanl because lhe cIinicaI lriaIs
vere nol designed lo inuence suicide. Laughren furlher announced lhal lhe drug
is nol aroved for lhe lrealmenl of suicide. They are aroved for lhe lrealmenl of
deression.
128
Laughren had been invoIved in discussions vilh IIi LiIIy and IDA
ociaIs on lhis issue in 1991. |See Inlry Augusl 8.j
November: DougIas Kennedy of IOX NalionaI Nevs in lhe U.S. roduced a lhree-
arl series on rescribed sycholroic drugs causing vioIence and exosed hov
condenliaI drug comany records shoved IaxiI vas 8 limes more IikeIy lo cause
individuaIs lo commil suicide lhan if laking a Iacebo. Iurlher, 7 oul of lhe Iasl 12
schooI shoolers had been on lhese lyes of drugs or vilhdraving from lhem rior lo
commiuing acls of vioIence.

In 2002, a Duke Universily sludy delermined lhere vas a Iink belveen IIi LiIIys
anlisycholic drug, Zyrexa, and diabeles aher documenling nearIy 300 cases
of diabeles in eoIe using lhe drug. The rilish MedicaI ConlroI Agency and lhe
}aanese HeaIlh and WeIfare Minislry varned aboul diabeles risks amongsl Zyrexa
alienls.
129

2003
IDA ociaI Dr. Andrev MoshoIder revieved 22 sludies and found lhal chiIdren given
anlideressanls vere nearIy lvice as IikeIy lo become suicidaI as lhose given Iacebos.
His IDA bosses, hovever, disagreed vilh his ndings, kel his recommendalions
secrel and inilialed a nev anaIysis by CoIumbia Universily. Hovever, CoIumbias
ndings reIeased in 2004 suorled MoshoIders concIusions.
130

March: A GIaxoSmilhKIine memo on lhe suicide risk in chiIdren laking IaxiI slaled, Il
vouId be unaccelabIe lo incIude a slalemenl lhal ecacy has nol been demonslraled,
as lhis vouId undermine lhe roIe of aroxeline.
131

March: The U.S. ChiId Medicalion Safely Acl vas inlroduced inlo lhe U.S. House of
Reresenlalives, rohibiling schooI ersonneI from coercing arenls inlo uuing lheir
chiId on sychialric drugs as a requisile for educalionaI services. CCHR vorked vilh
arenls and doclors lo gel lhis safeguard IegisIaled.
May: GIaxoSmilhKIine submiued a nev reorl lo lhe IDA shoving lhal chiIdren
given IaxiI vere more IikeIy lo become suicidaI lhan lhose given Iacebos and did nol
imrove lheir deression any beuer lhan lhe Iacebo.
132

June 10: rilains Dearlmenl of HeaIlh recommended lhal Seroxal (IaxiI) nol be used
lo lreal deression in lhose under lhe age of 18, slaling, Il has become cIear lhal lhe
benels of Seroxal in chiIdren, for lhe lrealmenl of deressive iIIness, do nol oulveigh
lhese risks.
133

June 19: The IDA said lhal il vas revieving reorls of increased risk of suicidaI
lhinking and suicide auemls in chiIdren and adoIescenls using IaxiI.
134

July: A Iinnish sludy ubIished in The Archives of General Psychiatry found lhal infanls
vhose molhers look SSRIs during regnancy couId suer neuroIogicaI robIems
during lheir rsl veek of Iife. The symloms incIuded lremors, reslIessness and
rigidily. Irevious sludies had shovn lhal regnanl vomen laking SSRIs during
lhe lhird lrimesler of regnancy couId exerience neuroIogicaI symloms such as
irrilabiIily, conslanl crying, convuIsions and ealing and sIeeing disorders.
135

August 22: Wyelh IharmaceulicaIs, lhe makers of lhe anlideressanl Iexor, issued a
varning lo U.S. doclors lhal lhe drug couId cause hosliIily, suicidaI idealion and seIf-
harm in alienls under lhe age of 18.
136

September: The IDA requesled lhe makers of six nev anlisycholic drugs, incIuding
Zyrexa, add a caulion lo lheir IabeIing Ianguage aboul lhe olenliaI risk of diabeles
and bIood-sugar abnormaIilies.
137

September 21: The Hartford Courant exosed hov anlideressanl makers and lhe IDA
had covered u informalion aboul anlideressanl risks and lhal IIi LiIIy execulives
vorked cIoseIy vilh IauI Leber, head of lhe IDAs NeuroharmaceulicaI Drug Division
in lhe 1990s lo deecl media auenlion avay from lhe facl lhal anlideressanls couId
cause suicide and vioIence lhal CCHR vas exosing al lhe lime.
138
|See }uIy/Oclober
1990 enlries.j
September: A GIaxoSmilhKIine memo udaled concerns over IaxiI causing a high
incidence of suicide and hosliIily bul inslrucled saIes reresenlalives in boId Ieuers nol
lo discuss lhe conlenls vilh doclors. GSK agreed lo discIose lhe memo lo seuIe lhe
Iavsuil Ied againsl il by lhe Nev York auorney generaI, vho accused lhe comany
of fraud for conceaIing lhe negalive resuIls.
139

September: The IDA delermined lhal IIi LiIIys anlisycholic drug Zyrexa required
IabeIing changes as a resuIl of a muIli-year reviev. The IabeIing varned of diabeles
risks.
140

October: The Irish MedicaI oard (IDA equivaIenl) rohibiled GIaxoSmilhKIine from
cIaiming lhal Iaroxeline (IaxiI) correcled a chemicaI imbaIance.
141

December 10: The rilish Medicines and HeaIlhcare Iroducls ReguIalory Agency
rohibiled lhe use of six more anlideressanls on chiIdren Iess lhan 18 years of age
because of suicidaI idealion. The IDA resonded by slaling il vouId invesligale lhis
furlher.
142

December 18: IIi LiIIy senl a Dear HeaIlhcare IrofessionaI Ieuer lo aII hysicians
in lhe UK, headed, IrozacNo Ionger aulhorized for lrealmenl of Ire-menslruaI
Dyshoric Disorder (IMDD), and said lhe reason for vilhdraving Irozac as a
lrealmenl for lhis vas because IMDD is nol a veII-eslabIished disease enlily across
Iuroe. Il is nol Iisled in lhe InlernalionaI CIassicalion of Diseases (ICD) and
remains onIy a research diagnosis in lhe American Isychialric Associalions DSM-IV
cIassicalion.
143

2004
January 5: A memo by Dr. Thomas Laughren, of lhe IDAs Division of Isychialric
Iroducls, said 12 of 15 sludies invoIving chiIdren lrealed for ma|or deression
shoved no ecacy vhen comaring lhe anlideressanls lo Iacebo. He indicaled
lhere vas lhe olenliaI for increased risk of suicide auemls and/or suicide-reIaled
behavior in ve oul of seven anlideressanls lesled in edialric cIinicaI lriaIs.
144

February 1: The San Francisco Chronicle ran an arlicIe reveaIing lhal IDA medicaI ocer
Dr. Andrev MoshoIder had been asked by lhe agency lo erform a safely anaIysis of
anlideressanls aher reorls emerged in }une 2003 of high rales of suicidaI behavior
among chiIdren enroIIed in cIinicaI lriaIs for SSRI anlideressanls. MoshoIder vas lo
have resenled his reorl al lhe Iebruary 2, 2004 IDA advisory commiuee hearing
on anlideressanls causing suicide in chiIdren and leens bul IDA ociaIs barred him
from leslifying.
February 2: The IDA advisory commiuee hearing on anlideressanls vas heId
comrising lhe IsychoharmacoIogic Drugs Advisory Commiuee and lhe Iedialric
Subcommiuee of lhe Anli-Infeclive Drugs Advisory Commiuee. IDA ociaI Dr.
Andrev MoshoIder leslied lhal adverse reaclion evenls had been reorled lo lhe IDA
regarding chiIdren being rescribed SSRIs lhal indicaled, lhere vere a lolaI of 524
case reorls, of vhich 110 vere dealh reorls. There vere 7 comIeled suicides and
67 auemled suicides.
145
The commiuees recommended lhal lhe IDA slrenglhened
varnings aboul lhe risk of suicide idealion and auemls vilh anlideressanls in
chiIdren as soon as ossibIe.
146
The commiuee heard from over 60 eoIe during lhe
meelings ubIic hearing, of vhich many vere arenls of chiIdren vho had commiued
or auemled suicide or homicide aher a shorl lime on anlideressanls. The arenl
leslimony vas very simiIar lo lhe anecdolaI evidence resenled in lhe 1991 IDA
hearing lhal CCHR had oblained and, Iike lhe 1991 hearing, sychialrisls cIaimed lhal
lhe suicidaI and olher eecls vere caused by lhe ersons menlaI iIIness. Hovever,
lhe advisory commiuee recommended varnings againsl lhe drugs. CCHR assisled
severaI arenls lhal leslied.
March 22: The IDA issued an advisory lhal il had requesled 10 anlideressanl
manufaclurers lo incIude in lheir IabeIing a varning recommending cIose observalion
of aduIl and edialric alienls laking anlideressanls for vorsening deression or
lhe emergence of suicidaIily. Iurlher, Anxiely, agilalion, anic auacks, insomnia,
irrilabiIily, hosliIily, imuIsivily, akalhisia (severe reslIessness), hyomania, and mania,
have been reorled in aduIl and edialric alienls being lrealed vilh anlideressanls
bolh sychialric and non-sychialric.
147

March 24: The U.S. House Inergy and Commerce Subcommiuee on Oversighl and
Invesligalions chaired by Texas Reresenlalive }oe arlon senl a Ieuer lo lhe IDA
slaling lhal lhey vere nov examining issues surrounding lhe safely and ecacy of
anlideressanls in lhe edialric/adoIescenl ouIalion and requesled aII vriuen
anaIyses, dala, corresondence and background informalion of cIinicaI lriaIs invoIving
deressed chiIdren.
148

April 3: ChiIdren 5 years oId and younger had become lhe faslesl-groving segmenl of
lhe non-aduIl ouIalion rescribed anlideressanls.
149

Cn.v+i 8:
i.cx ox W.NiNos
Tni Ti+n Anoi+ Siiciui Rivi.iiu
April 19: The rsl nalionvide cIass aclion suil vas Ied againsl a harmaceulicaI
comany over ils anlisycholic drug Zyrexa lhal vas Iinked lo dangerous adverse
eecls incIuding diabeles, hyergIycemia, and ancrealilis.
150

May 20: Mrs. Kim Wilczak Ied a vrongfuI dealh Iavsuil againsl Izer in lhe Counly of
Hennein Dislricl Courl, Iourlh }udiciaI Dislricl, in MinneaoIis, Minnesola cIaiming
lhal ZoIoh caused her husband, Woody, lo exerience severe side eecls lhal caused
him lo commil suicide. He had been rescribed ZoIoh lo heI him sIee and had no
rior bouls vilh deression, Wilczak conlended. The key lo lhe case vas vhelher
Izer gave adequale varning lhal use of ZoIoh couId Iead lo suicidaI lendencies.
151

June: The Nev York auorney generaI Roberl Silzer sued GIaxoSmilhKIine, aIIeging
ersislenl fraud in suressing research shoving suicide risk from IaxiI lo lhose
under 18. The comany seuIed lhe case in Augusl 2004 for $2.5 miIIion.
152
In lhe
documenls made ubIic as a resuIl of lhis case, lhree GSK Iacebo-conlroIIed sludies
faiIed lo shov lhal IaxiI vas more eeclive lhan Iacebo.
153
As arl of lhe seuIemenl,
GSK agreed lo creale a ubIic veb sile lo discIose aII cIinicaI lriaI resuIls, incIuding
lhose negalive.
154

July: Izer auemled lo dismiss Wilczaks suil againsl ZoIoh cIaiming lhal because
lhe IDA had nol required il lo add a varning for suicidaIily for adults laking lhe drug.
Shoving ils coIIusion vilh lhe drug induslry, IDAs chief counseI DanieI Troy |oined
Izer in lhis aIicalion.
155
|See Selember 2002 DanieI Troy enlry.j
August 20: CoIumbia Universilys anaIysis of sludies of edialric anlideressanl use,
commissioned by lhe IDA, found lhal anlideressanls vere IikeIy lo Iead chiIdren lo
become suicidaI.
156

August 25: Izer udaled ZoIoh rescribing informalion lo varn of suicidaI behavior.
Il aIso advised famiIies and caregivers of alienls being lrealed vilh anlideressanls
lo be aIerl lo lhe need lo monilor alienls for lhe emergence of agilalion, irrilabiIily
as veII as lhe emergence of suicidaIily, and lo reorl such symloms immedialeIy lo
heaIlh care roviders.
September 9: The U.S. House Inergy and Commerce Subcommiuee on Oversighl
and Invesligalions chaired by Texas Re. }oe arlon heId lhe rsl of severaI hearings
focusing on lhe use of anlideressanls in chiIdren and adoIescenls and lhe IDAs
decision nol lo discIose sludy resuIls shoving lhal lhe drugs may cause chiIdren lo
become aculeIy suicidaI and vere no more eeclive lhan sugar Iacebo. The IDA vas
accused of slonevaIIing, sIov roIIing and Iain incomelence.
157
Re. arlon said
lhal lhe IDA deIiberaleIy refused lo lurn over e-maiIs, memos and olher documenls
lo lhe Subcommiuee lhal had been requesled. He heId u a coy of an e-maiI from
an IDA ociaI inslrucling olhers in lhe agency nol lo unearlh lhe documenls. The
Subcommiuee slaled lhey vouId ush lhe IDA and lhe drug induslry lo make more
informalion ubIic aboul cIinicaI lriaIs of anlideressanls incIuding ossibIe IegisIalion
requiring ubIic discIosure of such lo be submiued in bolh lhe House and Senale. Il
vas conrmed lhal lhey knovingIy vilhheId lhe damaging informalion aboul lhe
drugs from lhe ubIiclhe recise slonevaIIing lhal CCHR had faced vhen lrying lo
gel lhe IDA lo reIease ils documenls on anlideressanls in 1993.
158

September 13 & 14: The IDAs IsychoharmacoIogicaI Drugs and Iedialric Advisory
Commiuees heId hearings lo discuss vhelher lo caII for slronger varning IabeIs
on anlideressanls and reorl lhe ndings of a sludy lhe IDA had conlracled vilh
CoIumbia Universily lo Iook inlo vhelher anlideressanls caused suicidaI behavior
in chiIdren. CCHR assisled severaI eoIe lhal leslied before lhe hearings.
159
The
commiuees recommended lhal lhe IDA require anlideressanl makers lo Iace lhe
IDAs slrongesl bIack box varning on ackaging informalion. Teslimony aboul ZoIoh
aIso concenlraled on lhe drugs Iack of roven ecacy in lrealing deression.
160

September: The IDAs IauI Leber loId The Denver Post, Second generalion
anlideressanls vere aroved by reguIalory rocess lhal requires Iimiled roof of
ecacy and safely.
161

September 24: The U.S. House Inergy and Commerce Commiuee heId a hearing vhere
IDA ociaIs vere caIIed lo ansver aIIegalions lhal lhey had suressed documenls
shoving lhal anlideressanls couId cause suicide in chiIdren. Congressmen noled
lhal vilh no benel lo recommend lhem and a risk for suicidaI behavior, lhe members
said lhey couId nol undersland vhy lhe agency did nol ban lhe drugsvhich CCHR
had caIIed for 14 years earIier. Dr. Roberl TemIe, head of lhe IDAs medicaI aairs,
resonded lhal |usl because lhe lriaIs had faiIed lhey shouIdnl discard lhe drug nol
vorking! More lhan 50 ercenl of aII lriaIs in aduIls faiI, loo, he said. We donl knov
vhy.
162
There is somelhing lerribIy rouen al lhe IDA, said Re. Ieler Deulsch
(D-IIa.). No agency charged vilh rolecling ubIic heaIlh shouId have behaved vilh
such indierence.
163

September: A sludy lilIed, Aggression, Mania, and Hyomania Induclion Associaled
vilh Alomoxeline (Slralerra), ubIished in Pediatrics, lhe |ournaI of lhe American
Academy of Iedialrics, reveaIed lhal 33% of lhe alienls revieved exhibiled exlreme
irrilabiIily, aggression, mania or hyomania.
164
Slrauera vas rescribed IargeIy lo
chiIdren vilh so-caIIed ADHD.
October 12: Dr. Richard Kail, lhe former IDA chief safely invesligalor vho invesligaled
Irozac, IaxiI and ZoIoh before lhe drugs vere aIIoved on lhe U.S. markel, leslied
in a murder case Iinked lo ZoIoh lhal he aIvays susecled in some alienls lhe drugs
couId cause mania, a condilion lhal can Iead lo vioIence. In lhe sychialric rofession,
anlideressanls have aIvays been lhoughl lo cause manic eisodes, Kail said. Nov,
ve have hard dala lo back u vhal everyone sorl of beIieved.
165
|See March 1985 and
March 23, 1986 enlries.j
October 15: The IDA ordered harmaceulicaI comanies lo add a bIack box
varning lo anlideressanls aIerling lhal lhey couId cause suicidaI lhoughls and aclions
in some chiIdren and leenagers. Dr. Roberl TemIe of lhe IDA, lhal had aroved
Irozac for lhe markel in 1987, had defended il foIIoving lhe 1991 IDA Hearing lhal
CCHR heIed insligale, vas quoled in lhe British Medical Journal as saying he found il
inleresling and ersuasive lhal aII drugs, incIuding Irozac, shoved lhe same lrend
lovard increased suicidaIily.
166

December 3: The Irohibilion on Mandalory Medicalion Amendmenl of lhe IndividuaIs
vilh DisabiIilies Iducalion Acl (IDIA) Iav vas enacled banning schooI ersonneI
forcing arenls lo adminisler sycholroic drugs lo lheir chiIdren as a requisile for
lheir educaliona safeguard lhal CCHR had been seeking since 2002.
December 4: AC (U.S.) nalionaI TV shov, Irime Time, exosed hov harmaceulicaI
records for 62% of alienls in cIinicaI lriaIs laking lhe anlideressanl IaxiI exerienced
vilhdravaI symloms.
2005
January 4: The oce of U.S. Re. Maurice Hinchey rovided CNN coies of IIi LiIIy
documenls lhal shoved lhe comany had dala vhen Irozac vas aroved in 1987
lhal ADRs vere far more IikeIy lo Iisl suicide and vioIence lhan reorls for olher
anlideressanls. One of lhe documenls reorled 14,198 adverse eecls, of vhich a
LiIIy ociaI indicaled 3.7% vere suicide auemls, yel lhe rale vas far higher for any
of four olher commonIy used anlideressanls. Iurlher, 2.3% of lhe adverse reaclions
concerned sycholic deression, more lhan doubIe lhe nexl-highesl rale of alienls
using any olher anlideressanl. And 1.6% invoIved incidenls of hosliIilymore lhan
doubIe lhe rale reorled on any olher commonIy used anlideressanls.
168
January 13: The Louisiana Auorney GeneraI Ied a Iavsuil againsl IIi LiIIy aIIeging
unfair lrade raclices by frauduIenlIy misreresenling lo doclors and ubIic lhal
Zyrexa vas safe and more eeclive lhan aIlernale drugs on lhe markel and romoling
o-IabeI use of lhe drug in chiIdren and for non-aroved uses.
169

February 17: An anaIysis of hundreds of sludies invoIving 87,650 alienls laking
anlideressanls shoved lhal aduIls vere more lhan lvice as IikeIy lo aueml suicide
as alienls given sugar iIIsand had been knovn for 15 years, vhen CCHR and
olhers rsl raised lhis. The sludy, ubIished in lhe currenl issue of lhe British Medical
Journal, vas conducled by eidemioIogisl Dean Iergusson and coIIeagues al lhe
Ouava HeaIlh Research Inslilule and incIuded scienlisls from McGiII Universily. The
biggesl concern is lhese drugs are videIy rescribed. There are miIIions of eoIe
on lhe drugs, so even a risk of one in a 1,000 vhen you amIify il lo lhe miIIions, il
becomes a ubIic heaIlh issue, Iergusson slaled.
170

April 11: The IDA issued a IubIic HeaIlh Advisory regarding lhe use of anlisycholic
drugs in eIderIy alienls vilh demenlia, slaling lhe drugs can cause an increase in
dealh rales and manufaclurers vouId be required lo Iace a boxed varning in lheir
ackaging informalion.
171

May: More lhan 100 doclors and medicaI rofessionaIs, incIuding medicaI advisory
board members of CCHR, signed a |oinl Ieuer lo lhe IDA Commissioner, Dr. Lesler
Cravford, caIIing for slronger varnings on anlideressanls and olher sycholroic
drugs IabeIing. The doclors aIso indicaled lhal sychialrisls and adverlisemenls lhal
cIaimed anlideressanls correcled a chemicaI imbaIance in lhe brain vas frauduIenl
and shouId be invesligaled.
June: InlernalionaI media ran on crilicism of sychialrisls misIeading consumers
aboul lhe dangers of anlideressanls and slimuIanls and hov lhere vas no scienlic
evidence lhal a chemicaI imbaIance exisled for anlideressanls lo correcl. There
vas aIso crilicism aboul rescribing anlideressanls lo regnanl vomen because of
lhe risk of felaI damage. |See Selember 27, 2005 enlry lhal subslanlialed lhis risk.j
In lhe vake of lhe unreIenling exosure on }uIy 1, Dr. Sleven Sharfslein, residenl of
lhe American Isychialric Associalion vas forced lo ubIicIy admil lhal lhere is no
cIean cul Iab lesl lo delermine a chemicaI imbaIance in lhe brain.
172
Dr. Mark Gra,
Chair of IubIic Aairs of lhe AIA said lhal lhis lheory vas robabIy drug induslry
derived We donl have lesls because lo do il, youd robabIy have lo lake a chunk of
brain oul of someonenol a good idea.
173

June 29: In an inlerviev on nalionaI TV Dr. Nada SlolIand, AIA Vice Iresidenl misIed
bolh lhe inlerviever and audience by cIaiming, We have brain iclures of eoIe
vho have deression and eoIe vho donl. You can see lhe dierence in lheir brain
images. You can see vhen lhey are lrealed successfuIIy, eilher vilh medicalion or vilh
sycholheray or bolh, lheir brain relurns lo normaI. Hovever, an Oclober 18 New
York Times slory reorled, Aher aImosl 30 years, researchers have nol deveIoed any
slandardized looI for diagnosing or lrealing sychialric disorders based on imaging
sludies. Iurlher, lhe U.S. Surgeon GeneraIs 1999 denilive reorl on menlaI iIIness
had slaled: The recise causes (elioIogy) of menlaI disorders are nol knovn and lhal
lhere is no denilive Iesion, Iaboralory lesl, or abnormaIily in brain lissue lhal can
idenlify |a menlaIj iIIness.
June 30: The IDA issued a IubIic HeaIlh Advisory enlilIed, SuicidaIily in AduIls
eing Trealed vilh Anlideressanl Medicalions slaling lhal severaI recenl scienlic
ubIicalions suggesl lhe ossibiIily of an increased risk of suicidaI behavior in adults
laking anlideressanls.
174

June 30: The IDA issued an AIerl for HeaIlhcare IrofessionaIs on lhe nev
anlideressanl CymbaIla, concIuding lhal suicidaI lhinking or behavior may increase
in edialric alienls lrealed vilh any lye of anlideressanl. The IDA issued lhis
varning desile nol having aroved lhe drugs use in chiIdren.
175

cIinicaI lriaIs on ossibIe increased suicidaI behavior in aduIls.
176

July 5: CCHR vrole lo }an N. }ohannessen, Ixeculive Secrelary, Senior Science
IoIicy AnaIysl, Oce of Science and HeaIlh Coordinalion, IDA regarding lhe need
for slronger varnings againsl slimuIanls and requesling aclion lo be laken againsl
manufaclurers making faIse cIaims lhal ADHD vas a neurobioIogicaI disorder vhen
lhere vas no scienlic/hysicaI evidence lo subslanliale lhis. Ior examIe, on May 6,
2004, lhe manufaclurer of AdderaII had issued a IR Nevsvire, deniliveIy slaling,
ADHD is a neurobioIogicaI disorder. No aclion vas laken.
July 5: The IDA issued anolher advisory lo heaIlhcare rofessionaIs, slaling: IDA
has concIuded lhal suicidaI lhinking or behavior may increase in edialric alienls
lrealed vilh any lye of anlideressanl, eseciaIIy earIy in lrealmenl. Increases in
suicidaI lhinking or behavior due lo drug can be execled in aboul 1 oul of 50 lrealed
edialric alienls.
July 16: The British Medical Journal ubIished a sludy, Icacy of anlideressanls
in aduIls, by }oanna Moncrie, senior Ieclurer in sychialry al Universily CoIIege
London, and Irving Kirsch, vho found lhal anlideressanls vere no more eeclive
lhan Iacebo and do nol reduce deression. Moncrie found no good evidence lhal
lhese drugs vork.
177

July 21: }udge denied Izers aIicalion lo dismiss Mrs. Kim Wilczaks vrongfuI
dealh suil. Izer had asserled lhal IDA reguIalions re-emled slronger faiIure-lo-
varn slale Iavsif lhe IDA did nol issue secic drug varnings, lhen slales couId nol
execl harmaceulicaI comanies lo do so, even vhen lhey had evidence of serious
adverse reaclions. U.S. Dislricl }udge }ames Rosenbaum ruIed lhal IDA varning
slandards vere minimum slandards. He aIso said lhe mass markeling of rescrilion
drugs in rinl and on leIevision has crealed a nev aeaI for lhese medicines lhal
creales an environmenl lhal caIIs oul for enhanced consumer roleclion.
179

July 22: IIi LiIIy, lhe manufaclurer of lhe anlisycholic drug, Zyrexa, agreed lo ay
$690 miIIion lo seuIe more lhan 8,000 cIaims againsl lhe drug aIIeging il can olenliaIIy
caused Iife-lhrealening diabeles.
180
y 2008, lhe suils had increased lo 30,000 vilh a
ayoul of $1.2 biIIion. |See }anuary 30, 2008 enlryj
August 19: The Commission of lhe Iuroean Communilies, reresenling 25 counlries,
issued lhe slrongesl varning yel againsl chiId anlideressanl use as recommended
by Iuroes Commiuee for MedicinaI Iroducls for Human Use (CHMI). A reviev
of cIinicaI lriaIs had shovn lhe drugs caused suicidaI behavior incIuding suicide
auemls and suicidaI idealion, aggression, hosliIily (redominanlIy aggression,
oosilionaI behavior and anger) and/or reIaled behavior.
August 22: Norvegian researchers ubIished lheir sludy of more lhan 1,500 alienls,
enlilIed, Suicide auemls in cIinicaI lriaIs vilh aroxeline |IaxiIj randomized againsl
Iacebo in lhe BMC Medicine lhal found aroxeline vas 7 limes more IikeIy lo induce
suicide lhan lhose laking Iacebo. The dala slrongIy suggesls lhal lhe use of SSRIs is
connecled vilh an increased inlensily and suicide auemls er year.
181

September: The Ividence-based Iraclice Cenler of Oregon HeaIlh & Science Universily
ubIished a reorl in vhich 2,287 sludiesvirluaIIy every sludy ever conducled
on ADHD drugsvere revieved. This delermined lhal no lriaIs have shovn lhe
eecliveness of lhese drugs and lhal lhere vas a Iack of evidence lhal lhey couId aecl
academic erformance, risky behaviors, sociaI achievemenls, elc.
182

September 22: Dr. }erey Lieberman of CoIumbia Universily and olher researchers
reIeased a federaIIy funded sludy in lhe New England Journal of Medicine lhal
delermined lhal lhe never anlisycholic dugs vere no more eeclive or safer lhan an
oIder anlisycholic. One of lhe never drugs vas Zyrexa and aher 18 monlhs, 64% of
lhe alienls laking lhis had sloed, mosl ohen because il vas nol veII loIeraled and
caused sIeeiness, veighl gain or neuroIogicaI symloms Iike sliness and lremors.
183

Of lhe 1,493 alienls vho arlicialed, 74% disconlinued lheir anlisycholic drug
before lhe end of lheir lrealmenl due lo inecacy, inloIerabIe side eecls or olher
reasons.
184

September 27: The IDA and GIaxoSmilhKIine issued a varning lhal regnanl
vomen laking IaxiI or olher anlideressanls during lheir rsl lrimesler of regnancy
vere al risk of giving birlh lo babies suering ma|or congenilaI |defecl al birlhj and
cardiovascuIar |hearlj maIformalions. There vere aIso been reorls of remalure
birlhs in regnanl vomen exosed lo SSRIs, incIuding IaxiI.
185

September 29: The IDA issued a IubIic HeaIlh Advisory direcling a revision in
lhe IabeIing of lhe anlideressanl Slrauera (rescribed as a slimuIanl for so-caIIed
ADHD) lo incIude bolh a boxed varning and addilionaI varning slalemenls lhal
aIerled heaIlh care roviders lo an increased risk of suicidaI lhinking in chiIdren and
adoIescenls being lrealed vilh lhe drug.
186

November: The IDAs Safely Informalion and Adverse Ivenl Reorling Irogram
reorled homicidal ideation as an adverse evenl of lhe anlideressanl Iexor.
187

November: CCHR senl coies of media exosing hov anlideressanls caused
vioIence and suicide lo 400,000 doclors in lhe U.S. Anolher Ieuer senl lo 100,000
doclors reminded lhem of lheir resonsibiIily lo reorl drug adverse reaclions lo lhe
IDA using ils MedWalch reorling form.
November 8: U.S. Dislricl }udge SamueI Der-Yeghiayan found againsl Izer in a Iavsuil
aboul ZoIoh. The vidov of a man, DonaId Zikis vho died from suicide vhiIe laking
ZoIoh, argued lhal Izer had faiIed lo roerIy varn users of lhe drugs dangerous
side eecls. The courl re|ecled Izers asserlion lhal had il added varnings lo ils IabeI,
il mighl misIead hysicians aboul lhe risks enlaiIed in rescribing a drug, lhereby
over-delerring ils use. The |udge disagreed and oinled oul lhal lhe comany can
add any varning, recaulion or adverse reaclion vilhoul lhe rior IDA arovaI.
188

December: A sludy ubIished in PLoS Medicine (IubIic Library of Science) delermined
lhal neuroscienlic research had faiIed lo conrm any chemicaI abnormaIily in lhe
brain requiring anlideressanls lo correcl. Neuroscienlic research, lhe reorl said,
had faiIed lo conrm any serolonin abnormaIily in lhe brain.
189

2006
January 5: The IDA said lhal il had received reorls of sudden dealhs, slrokes,
hearl auacks and hyerlension (high bIood ressure) in bolh chiIdren and aduIls
laking ADHD slimuIanls such as RilaIin, AdderaII and CeIexa. The IDA asked ils
Drug Safely and Risk Managemenl advisory commiuee lo examine lhe olenliaI of
cardiovascuIar (hearl) risks of lhe drugs.
190
RilaIin had been on lhe markel for more
lhan 40 years, vilhoul sychialrisls or lhe IDA acling lo varn arenls of lhese risks.
February: The AIaska Auorney GeneraIs oce Ied suil againsl IIi LiIIy for iIIegaI
markeling of Zyrexa for o-IabeI condilions. The suil aIso aIIeged lhal lhe comany
knev aboul lhe drugs olenliaI diabelic and hyergIycemic side eecls and soughl
reimbursemenl and enaIlies.
191
Wesl Virginia Ied a simiIar suil on Iebruary 28.
February 6: A sludy ubIished in lhe Archives of Pediatrics and Adolescent Medicine
delermined lhal nearIy one-lhird of nevborn infanls vhose molhers look SSRI
anlideressanls during regnancy exerienced vilhdravaI symloms lhal incIuded
high-ilched crying, lremors and dislurbed sIee.
193

February 9: The IDAs Drug Safely and Risk Managemenl Advisory Commiuee heId
a hearing inlo slimuIanl drug risks. CCHR assisled severaI arenls lhal leslied and
vho urged lhal lhe slrongesl bIack box varning be issued.
194
The advisory aneI
voled in favor of lhe bIack box varning, recommending lhis lo lhe IDA. The IDA
aroved slronger varnings, bul nol a bIack box. CCHR resenled informalion lo
members of Congress on lhe dangers of lhese drugs lhal il had invesligaled since lhe
1980s.
March: A sludy ubIished in The New England Journal of Medicine reorled use of
SSRIs during lhe second haIf of regnancy couId be associaled vilh a rare bul Iife-
lhrealening condilion vhere lhe infanl does nol receive sucienl oxygen in lhe bIood
and required inlensive-care lrealmenl lo survive. According lo lhe sludy, babies born
vilh lhis condilion vere six limes more IikeIy lhan heaIlhy babies lo have been exosed
lo SSRIs.
195

March 22: An IDA advisory aneI heId a hearing inlo lhe risk of slimuIanls rescribed
for lhe lrealmenl of ADHD. Ividence reveaIed lhal from }anuary 2000 lo }une 30,
2005, lhe IDA had received aImosl 1,000 reorls of kids exeriencing sychosis or
mania vhiIe laking slimuIanls. The aneI recommended increasing lhe varnings
aboul lhe drug dangers, emhasizing lhese on seciaI handouls caIIed Med Guides
lhal doclors musl give lo alienls vilh each rescrilion.
April 12: CCHR vrole lo IDA Commissioner Dr. Andrev C. von Ischenbach caIIing
for slronger varnings againsl slimuIanls and raised concerns aboul adverlisemenls
lhal made cIaims lhal ADHD vas a neurobioIogicaI disorder vhich vas faIse
and misIeading and, lherefore, in vioIalion of Seclion 202.1 of TilIe 21 of lhe Code of
IederaI ReguIalions. Il rovided examIes of harmaceulicaI comany adverlising
and a NelherIands courl decision lhal had rohibiled ADHD being adverlised as a
brain-based disorder. CCHR requesled an invesligalion inlo lhis misreresenlalion in
sycholroic drug adverlising.
Cn.v+i 9:
Tni IDA is UN.viiiu
April 24: The Governmenl Accounling Oce (GAO), a governmenl oversighl agency,
issued lhe ndings of ils invesligalion inlo lhe IDA, slaling, IDA Iacks a cIear and
eeclive rocess for making decisions aboul, and roviding managemenl oversighl
of, oslmarkel drug safely issues. Il vas incaabIe of roerIy moniloring adverse
drug reaclions once il had aroved lhe drug.
196
The harmaceulicaI induslry did nol
suorl any increased requiremenls for safely sludies aher a drug vas aroved.
197

May 12: GIaxoSmilhKIine and lhe IDA varned doclors lhal IaxiI increases lhe risk of
suicide in young aduIls.
198

May: A sludy ubIished in lhe |ournaI Psychotherapy and Psychosomatics reveaIed
lhe harmaceulicaI comany inuence on lhe DSM, vilh 56% of aII DSM commiuee
members having nanciaI inleresls in drug comanies. Ior so-caIIed mood disorders
(deression and bioIar) and schizohrenia/sycholic disorders, 100% of lhe
aneI members had undiscIosed nanciaI invoIvemenls vilh drug comanies.
199

June 30: An AIaska Sureme Courl ruIing delermined, Given lhe nalure and
olenliaIIy devaslaling imacl of sycholroic medicalionsve nov simiIarIy hoId
lhal lhe righl lo refuse lo lake sycholroic drugs is fundamenlaI. Recognizing
lhe risks of lhese drugs, lhe courl slaled: Isycholroic drugs aecl lhe mind,
behavior, inleIIecluaI funclions, ercelion, moods, and emolion and are knovn lo
cause a number of olenliaIIy devaslaling side eecls. Courls have observed lhal
lhe IikeIihood |lhal sycholroic drugs viII causej al Ieasl some lemorary side
eecls aears lo be undisuled and many have noled lhal lhe drugs maymosl
infamousIycause Iarkinsonian syndrome (disease of lhe nerves causing lremor,
muscIe veakness, shuing vaIk) and lardive dyskinesia (tardive, Iale and dyskinesia,
abnormaI movemenl of muscIes).
200

July 24: The slale of Mississii Ied a Iavsuil againsl IIi LiIIy, aIIeging imroer
saIes and markeling of Zyrexa. CiviI enaIlies, unilive damages and Iiligalion cosls
vere soughl.
201

August 21: Senalor CharIes GrassIey (R-IA) issued slalemenls and nalionaI media
crilicizing lhe IDA for quielIy requiring ADHD drug manufaclurers lo add varnings
lo lheir roducls, bul nol making lhe ubIic avare lhal lhese nev varnings vouId be
required.
September 11: In a sludy, ubIished in lhe |ournaI Public Library of Science Medicine, Dr.
David HeaIy and coIIeagues delermined lhal SSRI anlideressanls couId increase lhe
risk of vioIence in eoIe laking lhem. They Iooked secicaIIy al IaxiI and concIuded
lhe drug raised lhe risk of severe violence in some eoIe. The ndings vere based in
arl on cIinicaI lriaI dala GSK submiued lo lhe UKs Commiuee on Safely of Medicines
Ixerl Working Grou. The sludy slaled: In aroxeline cIinicaI lriaIs, aggression and
violence vere commonIy coded under lhe rubric of hosliIily. This coding lerm incIudes
homicide, homicidal acts, and homicidal ideation as veII as aggressive evenls and
conducl disorders, bul no homicides vere reorled from lhese lriaIs.
202

September 18: IDA Commissioner Dr. Andrev C. von Ischenbach resonded lo
CCHRs Ieuers commencing AriI 12, slaling, You asked aboul sles or reguIalions
IDA is laking lo inform drug manufaclurers lhal cIaim lhal lhere is a neurobioIogicaI,
hysicaI abnormaIily, or chemicaI imbaIance cause for any menlaI disorder is faIse and
misIeading adverlising. Hovever, vhiIe no evidence lo suorl lhe foIIoving, lhe
Commissioner vrole, The fact that there are no laboratory tests to diagnose ADHD does not
mean that ADHD is not a genuine disease (one that might be called a neurobiological disease)
So FDA thinks that referencing ADHD as a neurobiological disorder can be supported.
October: Congressman Dan urlon senl a Ieuer lo members of Congress (a coy of
vhich had been given lhe IDA) aIerling lhem lo lhe resuIls of a survey shoving 9 oul
of 10 Americans vere unavare lhal lhey had lhe righl lo reorl a drug adverse reaclion
lo lhe IDA. Congressman urlon demanded lhal lhe IDA mandale drug comanies
lo advise consumers lo reorl adverse eecls (ADRs) lo Medvalch.

December 13: The IDA heId a hearing inlo lhe reIalionshi belveen anlideressanls and
suicide in lhose 18-25 years of age (young aduIls). The IDA IsychoharmacoIogicaI
Commiuee heard leslimony from aboul 75 eoIe, incIuding a CCHR reresenlalive,
vho said lhe IDA had lhe informalion 15 years ago vhen CCHR oblained lhe 1991
IDA Hearing inlo Irozac causing suicide and vioIence, bul had faiIed lo acl. This lime
lhe commiuee voled lo exlend lhe bIack box varning on anlideressanls lo age 24.
November 27: The Nev Mexico Auorney GeneraI Ied a Iavsuil againsl IIi LiIIy
aIIeging lhe comany romoled lhe drug for o-IabeI uses (such as in chiIdren and in
eIderIy for demenlia, as veII as for non-aroved indicalion such as irrilabiIily, sIee
dislurbances and anxiely).
203

November 29: Acling IDA Commissioner Dr. Andrev C. von Ischenbach resonded
to CCHRs query aboul hov sycholroic drug adverlising can be aIIoved lo make
cIaims lhal menlaI disorders are neurobioIogicaI or lhe resuIl of a chemicaI imbaIance
vhen lhere vere no reIicabIe scienlic sludies lo suorl lhis. Dr. von Ischenbach
vrole, Regarding lhe issue of hov IDA makes a |udgmenl lhal any arlicuIar cIinicaI
enlily is a disease,ve, generaIIy, reIy on lhe exerls vilhin lhe cIinicaI, academic,
and governmenl communilies vho lreal and sludy lhese enlilies. There is virluaIIy
unanimous agreemenl among lhose ve consider exerls in ADHD, bioIar disorder,
and schizohrenia lhal lhese are Iegilimale diseases. He couId nol direcl CCHR lo
any secic evidence of lhis.

December 17 & 21: ArlicIes aearing in The New York Times discIosed lhal IIi LiIIy
had engaged in a decade-Iong eorl lo Iay dovn lhe heaIlh risks of Zyrexa and had
acliveIy markeled Zyrexa for iIIegaI o-IabeI uses.
204

2007
Throughout 2006 and 2007, CCHR, along with many concerned parents, doctors, healthcare
groups and whistleblowers worked to ensure that legislation governing the FDA would provide
safeguard and consumer protections. This included full disclosure of all clinical drug trial
results and the right for consumers to report drug adverse reactions to the FDA.
Cases of violent crimes compiled by the International Coalition for Drug Awareness also
recorded more than 950 acts of violence over an eight-year period, commied by people of all
ages taking SSRI antidepressants. This includes 362 murders; 45 aempted murders; over 100
acts of violence and assault, including 13 school shootings; 5 bomb threats or bombings; 24
acts of arson; 21 robberies; 3 pilots who crashed their planes; and more than 350 suicides and
suicide aempts.
February 21: The IDA direcled ADHD drug manufaclurers lo dislribule alienl-
friendIy guides lo consumers lhal slimuIanls couId cause serious sychialric and
cardiovascuIar robIems, incIuding slroke, hearl auack, sudden dealh and sycholic
reaclions.
February 26: The IennsyIvania Governors oce Ied a suil againsl IIi LiIIy, }anssen
and AslraZeneca, aIIeging lhey had frauduIenlIy markeled lheir anlisycholic drugs
(Zyrexa, RiserdaI and SeroqueI, resecliveIy) and oved lhe slale for rescrilion
cosls and harm lo alienls.
205

March 22: The House Inergy and Commerce Commiuees subcommiuee on oversighl
and invesligalions heId a hearing inlo lhe IDA and drug safely, al vhich IDA
commissioner Dr. Andrev von Ischenbach aeared. The IDAs lrealmenl of vhislIe-
bIovers had Iong been of concern lo members of Congress, slemming in arl from
aIIegalions lhe agency had relaIialed againsl emIoyees vho soke oul aboul safely
issues vilh lhe nov-vilhdravn ainkiIIer Vioxx and anlideressanls.
206

April 25: The IDA announced il vas invesligaling vhelher lhe manufaclurer of
Zyrexa had rovided il vilh accurale dala aboul lhe side eecls of lhe anlisycholic
drug. This vas based on a Iebruary 2000 documenl rovided lo lhe IDA in vhich lhe
manufaclurer admiued lhal il had found lhal alienls laking Zyrexa in cIinicaI lriaIs
vere lhree and a haIf limes more IikeIy lo deveIo high bIood sugar as lhose vho
did nol lake lhe drug. Thal documenl vas nol submiued lo lhe agency, vhiIe a fev
monlhs Ialer, lhe comany rovided dala lhal onIy shoved aImosl no dierence in
bIood sugar belveen alienls vho look Zyrexa and lhose vho did nol.
207

April: Over 350 Iavsuils vere Ied in AriI againsl AslraZaneca IharmaceulicaIs
aher lhe IDA ordered a change in lhe IabeIing of ils anlisycholic drug, SeroqueI,
lo varn users aboul an increased risk of diabeles. Iurlher, SeroqueI vas Iinked lo
ancrealilis (an inammalion of lhe ancreas), hyergIycemia, and NeuroIelic
MaIignanl Syndrome, a olenliaIIy falaI syndrome vilh symloms lhal incIude
irreguIar hearlbeal, fever, and sli muscIes. Il couId aIso increase lhe risk of dealh in
seniors vho had demenlia-reIaled menlaI robIems, a condilion lhal SeroqueI has nol
been aroved lo lreal.
208

April 26 2007: The nalionaI consumer roleclion grou, IubIic Cilizen, secured
an imroved seuIemenl for lhe arenls of lhousands of chiIdren rescribed lhe
anlideressanl IaxiI. The cIass aclion suil had soughl economic damages againsl lhe
manufaclurer, GSK, aIIeging lhe comany had misIed arenls by nol discIosing lhal
lhe drug vas dangerous and ineeclive vhen laken by chiIdren younger lhan 18. GSK
agreed lo ul $63.8 miIIion inlo a seuIemenl fund for viclims and auorneys fees.
209

March 7: The slale of Monlana sued IIi LiIIy for markeling Zyrexa for o-IabeI
uroses and aIIeged LiIIy oved lhe slale for drug cosls and lhe harm alienls have
suered from use of lhe drug and as a resuIl of ils markeling lhe drug lo sedale nursing
home alienls, and giving kickbacks lo doclors.
210

May 2: The IDA ociaIIy exlended lhe age grou for lhe bIack box varning aboul
anlideressanl inducing suicide from 18 lo 24.
211

July: CCHR oblained documenls from lhe AuslraIian Theraeulic Goods
Adminislralion regarding anlideressanl adverse reaclions. ChiIdren under 10 years
oId laking lhe drugs had suered 129 side eecls, vhiIe lhose 10 lo 19 years oId had
exerienced 1,149 reorled side eecls. There vere al Ieasl lvo suicides and one
dealh due lo hearl faiIure in lhe 10 lo 19 age grou. Olher adverse reaclions incIuded:
convuIsions, haIIucinalions, deafness and araIysis.
September: LegisIalion reforming lhe IDA vas assed, roviding consumer righls and
cIinicaI drug lriaI lransarency. Ior CCHR, lhis had been a 17-year bauIe lo correcl lhe
coIIusion belveen sychialrisls, harmaceulicaI comanies and lhe IDA. To rolecl
sychialric inleresls, consumers had been denied vilaI informalion aboul drug risks,
lheir evidence of serious adverse reaclions vere dismissed as anecdolaI and faIse
adverlising, misIeading cIaims and frauduIenl asserlions lhal chemicaI imbaIances
exisled had been aIIoved lo ourish in lhe media and in medicaI |ournaIs. Some of lhe
changes lo lhe IDA IegisIalion incIude:
Drug ads lo carry a consicuous nolice: You are encouraged lo reorl negalive
side eecls of rescrilion drugs lo lhe IDA. Visil vvv.fda.gov/medvalch or caII
1-800-IDA-1088.
Drug comanies required lo ubIicIy osl aII resuIls of lheir drug cIinicaI lriaIs
on lhe Inlernel, incIuding lhe negalive. They couId no Ionger seIecliveIy choose vhal
lhey vanl consumers lo knov.
If any drug maker submiued faIse informalion on a cIinicaI lriaI, lhe IDA
vouId osl a nolice slaling: The enlry for lhis cIinicaI lriaI vas found lo be faIse or
misIeading and lherefore nol in comIiance vilh lhe Iav.
The IDA vas mandaled lo monilor drug adverlisemenls and if lhey are faIse
or misIeading, ne drug makers u lo $10 miIIion.
2008
January: A New England Journal of Medicine sludy reorled lhal makers of SSRI
anlideressanls never ubIished lhe resuIls of aboul a lhird of lhe drug lriaIs lhal
lhey conducled lo gel governmenl arovaI, misIeading eoIe aboul lhe drugs
eecliveness. The published sludies shoved vhiIe aboul 50% of eoIe laking lhe
drugs reorled signicanl reIief, 40% laking Iacebo did loo. Iurlher, vhen facloring
in aII lhe unubIished sludies, lhe anlideressanls vere aboul as eeclive as laking
Iacebo. Researchers aIso found lhal 37 of 38 lriaIs lhal lhe IDA had revieved as
having osilive resuIls vere ubIished in |ournaIs, vhiIe of lhe 36 lriaIs lhal lhe agency
vieved as failed or unconvincing, onIy 14 of lhese vere ubIished.
212

January 30: IIi LiIIy and federaI roseculors discussed a seuIemenl of a criminaI and
civiI invesligalion inlo lhe comanys markeling of Zyrexa lhal couId resuIl in LiIIy
aying more lhan $1 biIIionlhe Iargesl ne ever aid by a drug comany for breaking
federaI Iavs lhal govern hov drugs can be romoled. Iarl of lhe agreemenl vouId
incIude LiIIy Ieading guiIly lo a misdemeanor criminal charge.
213
The comany had
aIready aid oul $1.2 biIIion lo seuIe 30,000 civiI Iavsuils againsl il over Zyrexa.

Tnr Uorn:v:c Pnon:rm: D:ncos1:c Fnnuo
CCHR, aIong vilh many olher Iike-minded individuaIs, grous and vhislIebIovers,
lenaciousIy soke oul aboul lhe serious risks associaled vilh anlideressanls and
olher IDA-aroved sychialric drugs for more lhan 14 years, before lhe IDAaIso
under CongressionaI ressureacled.
Isychialrisls abiIily lo convince drug comanies and governmenls lo our biIIions
of doIIars inlo ils raclices is based uon a frauduIenl diagnoslic crileria calaIogued
in lhe Diagnostic and Statistical Manual of Mental Disorders. Isychialrisls ackage
various behavior and emolionaI characlerislics and calegorize lhem as a disease or
disorder for vhich drugs can be manufaclured lo lreal. CarI IIIiol, a bioelhicisl
al lhe Universily of Minnesola, says: The vay lo seII drugs is lo seII sychialric
iIIness.
214

Irofessors Herb Kulchins and Sluarl A. Kirk have conducled exlensive research inlo
lhe DSM, and in lheir book, Making Us Crazy: The Psychiatric Bible and the Creation
of Mental Disorders, lhey summarized il lhis vay: DSMs denilion of menlaI
disorders is aved, lhe cIaims of vaIidily and reIiabiIily of lhe manuaI as a vhoIe
shaky, and lhe causes of mosl menlaI disorders are unknovnno manuaI shouId be
foisled on cIinicians or lhe ubIic and used for uroses of |insurancej reimbursemenl
unIess lhere is subslanliaI evidence for ils reIiabiIily and vaIidily. DSM is noloriousIy
unreIiabIe. Iurlher, sychialrisls and olher menlaI heaIlh rofessionaIs benel
from DSMs unreIenling exansion of domain, ils auemls lo svee aII manner of
ersonaI lroubIes under lhe medicaI umbreIIa and lo ralionaIize ils moves on lhe basis
of research and science.
215

Iven Dr. Roberl Silzer, lhe main archilecl of DSM loId The New Yorker in 2005, To say
lhal veve soIved lhe reIiabiIily robIem is |usl nol lrueif youre in a silualion vilh
a generaI cIinician ils cerlainIy nol very good. Theres sliII a reaI robIem, and ils nol
cIear hov lo soIve lhe robIem.
216

Cn.v+i 10:
ViNuic.+ioN s +ni Nix+ S+iv
Thal robIem viII never be soIved as Iong as lhere are harmaceulicaI doIIars
inuencing lhe AIA. In 2006, Dr. Irvin Savodnik, an assislanl cIinicaI rofessor of
sychialry al lhe Universily of CaIifornia, Los AngeIes, vas quoled in The Chicago
Tribune slaling, The very vocabuIary of sychialry is nov dened al aII IeveIs by lhe
harmaceulicaI induslry.
217

Reorled in 2007, 19 of lhe 27 members of lhe AIA lask force, delermining vhal
menlaI disorders are lo be incIuded in DSM-V due lo be ubIished in 2012, have
nanciaI lies lo harmaceulicaI comanies.
218

Crime comes in many forms. This incIudes organized crime and lhe idea of syndicale
bosses running nelvorks of Iesser criminaIs around lhe counlry vho commil lhe
deeds lhal bring lhe rackeleers lheir rols. When syndicales corrulion is oul in
lhe oen, ociaI and ubIic oulcry and aclion usuaIIy bring aboul some sociaI and
IegaI reslrainl. Yel loday, ve have oeraling oul in lhe oenIain for aII vho viII
Iook lo seea syndicale lhal conlinues lo ereluale lhe fraud lhal aII Iifes robIems
are caused by a disorder dened onIy by lhem. Irom reading and vriling disorder,
dgeling, sluuering, |el Iag and coee use disorder lo seIf-defealing ersonaIily and lhe
aII encomassing Ihase of Life IrobIem, lhis is lhe DSM. Yel because il is couched in
lerms of menlaI heaIlh care and science, lhe oulcry by lhose vho see il is foughl.
SliII, lhe deeening reIiance uon DSM in many sociaI seclors is under increasing
auack because of sychialrys AchiIIes heeI: il Iacks any scienlic vaIidily. }erey A.
SchaIer, Ih.D., Ieclurer al lhe American Universily in Washinglon, D.C., says, |Tjhe
nolion of scienlic vaIidily, lhough nol an acl, is reIaled lo fraud. VaIidily refers lo lhe
exlenl lo vhich somelhing reresenls or measures vhal il urorls lo reresenl or
measure. When diagnoslic measures do nol reresenl vhal lhey urorl lo reresenl,
ve say lhal lhe measure Iacks vaIidily. If a business lransaclion or lrade resled on such
a Iack of vaIidily, ve mighl say |lhisj vas an inslrumenlaI in a commilmenl of fraud.
The DSM-IV, ubIished by lhe American Isychialric Associalionis nolorious for Iov
scienlic vaIidily.
219

Yel lhe IDA reIies uon lhis frauduIenl documenl lo arove aII sychialric drugs.
There are no hysicaI lesls, incIuding brain scans or MRIs, lhal can rove lhe exislence
of any menlaI disorder. Canadian sychoIogisl Tana Dineen oinls oul, UnIike medicaI
diagnoses lhal convey a robabIe cause, aroriale lrealmenl and IikeIy rognosis,
sychialric disorders are lerms arrived al lhrough eer consensusIileraIIy, a vole
by AIA commiuee membersand designed IargeIy for biIIing uroses.
220

The IDA is faiIing in ils duly and lo fuIIy inform of aII lhe risks associaled vilh
sycholroic drugs and lhal lhey are aroved and rescribed for condilions lhal
cannol be scienlicaIIy or medicaIIy veried. The IDA shouId issue reguIalions
requiring harmaceulicaI comanies lo cease referring lo any menlaI disorder as
olenliaIIy caused by a chemicaI imbaIance or any neurobioIogicaI or olher hysicaI
condilion.
In lhis vay, olher organizalions lhal receive subslanliaI granls and funds from
harmaceulicaI comanies viII aIso be ul on nolice nol lo romole menlaI disorders
as such and lo varn aboul lhe very reaI risks of lhe drugs rescribed lo lreal lhem.
1. Invesligale lhe faiIure of lhe IDA lo lake aclion againsl faIse adverlising lhal
conlain cIaims lhal a menlaI disorder is neurobioIogicaI or lhe resuIl of a chemicaI
imbaIance in lhe brain. Issue reguIalions lhal rohibil such frauduIenl cIaims.
2. None of lhe 374 menlaI disorders in lhe DSM shouId be eIigibIe for insurance
coverage vilhoul reIicabIe scienlic, hysicaI vaIidalion.
3. Governmenl, criminaI, educalionaI, |udiciaI and olher sociaI agencies shouId
nol reIy on lhe DSM and no IegisIalion shouId use lhis as a basis for delermining lhe
menlaI slale, comelency, educalionaI slandard or righls of any individuaI.
4. GeneraI raclilioners, edialricians and neuroIogisls shouId nol use DSM for
diagnosing alienls condilions. No hysician, edialrician, neuroIogisl elc. shouId
reIy uon lhe DSM lo diagnose alienls.
5. IslabIish or increase lhe number of sychialric fraud invesligalion unils lo
recover funds lhal are embezzIed lhrough lhe menlaI heaIlh syslem because of lhe
DSM.
RicoxxiNu.+ioNs
1. }ohn Read, IeeIing Sad` Il Doesnl Mean Youre Sick, New Zealand Herald, 23 }une 2004.
2. KeIIy OMeara, addressing CCHR 34lh Anniversary and Human Righls Avards, Los AngeIes, 2003.
3. Donna K. H. WaIlers, Nev Anlideressanls Imerge lo ChaIIenge Irozac, Los Angeles Times, 8 }an. 1992.
4. V. H. Sharav, ChiIdren in cIinicaI research: A conicl of moraI vaIues, The American Journal of Bioethics, 3(1):
2003, ciling S. oseIey, They said il vas safe, The Guardian (UK), 30 Ocl. 1999.
5. Reviev and IvaIualion of Icacy Dala NDA 18-936, IIi LiIIy, 28 March 1986. Documenls oblained by
CCHR lhrough IOIA.
6. Iover vs IIi LiIIy, In lhe U.S. Dislricl Courl for lhe Dislricl of Havaii, ComIainl for Damages,
Irozac}usliceSeekers.com.
7. Dr. Richard DeGrandre, Anli-deressanls may be hazardous lo your heaIlh, Hartford Advocate, 20 Aug 2002.
8. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI Iavsuil, Nov. 1990.
9. Dr. Richard DeGrandre, Anli-deressanls may be hazardous lo your heaIlh, Hartford Advocate, 20 Aug 2002.
10. David HeaIy, Ansvers.com.
11. Richard Kail, M.D. Safely Reviev of NDA 18-936 (IIuoxeline) of 23 Mar. 1986
12. David HeaIy, Ansvers.com.
13. IOIA documenls oblained by CCHR, 1993.
14. Documenls oblained by CCHR lhrough IOIA.
15. Documenl oblained by CCHR lhrough IOIA.
16. }oseh GIenmuIIen, M.D., Prozac Backlash, (Simon & Schusler, NY, 2000), . 163.
17. McLaughIin, Craig, The Perils of Prozac, San Iernando Guardian, 16 May 1996.
18. Dr. R.M. Kail, Lisl of Irozac-reIaled seizures, Memorandum Del. HeaIlh and Human Service, IDA
Cenler for Drug IvaIualion and Research, 20 }an. 1988.
19. Gary NuII, Townsend Leer for Doctors, Irozac, IIi LiIIy and lhe IDA, Ieb-Mar. 1993
20. NeaI Knox Reorl, Mass Murder Link, Shotgun News, Omaha, Nebraska, 10 Dec. 1989, NeaI Knox, A
courageous viclim SIIAKS OUT! Guns & Ammo, Ocl. 1990.
21. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI suil, Nov. 1990.
22. Marlin H. Teicher, M.D., Ih.D., CaroI GIod, R.N., M.S.C.S., and }onalhon O. CoIe, M.D. Imergence of
Inlense SuicidaI Ireoccualion During IIuoxeline Trealmenl, The American Journal of Psychiatry, Ieb. 1990.
23. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI suil, Nov. 1990.
24. Sla Reorl, Whal has kel Irozac Iiligalion going for 10 years` Ior one lhing, lhe easy avaiIabiIily lo lriaI
Iavyers of hundreds of inlernaI documenls from IIi LiIIy and Co. A decades vorlh of Irozac, The Indianapolis
Star, 23 Ar. 2000.
25. }oseh GIenmuIIen, M.D., Prozac Backlash, (Simon & Schusler, NY, 2000), . 183, aum HedIund Lav
Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI suil, Nov. 1990.
27. Anaslasia Toufexis, Andrev Iurvis, Warnings Aboul a MiracIe Drug, Reorls of suicide auemls in Irozac
users raise doubls aboul lhe ouIar anlideressanl, Time Magazine, 30 }uIy 1990.
28. Richard Granl, The Irozac generalion, Irozac is lhe vonder drug lhal look lhe Uniled Slales by slore,
Sunday Review (London), 30 }an. 1994.
Irozac}usliceSeekers.com, aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy
civiI Iavsuil, Nov. 1990.
30. Dave AIlimari, Memos DisIay Drug Iirms Olimism OciaIs Were Condenl IDA WouId ack Them On
Suicide, VioIence Issues InvoIving IaxiI, Irozac, Hartford Courant, 21 Sel. 2003.
31. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI suil.
32. Irozac Causes VioIence, WideIy Used Drug Turns IeoIe VioIenl and SuicidaI. ArlicIe on CCHRs
dalabase, unnamed nevsaer, Sanford Iock, Leuer lo IDA, Mr. }ames S. enson, 8 Augusl 1990.
38. Prozac: The Killer Pill of the Nineties, Chaler 7, IDA Corrulion, Conicls of Inleresl exosed, on CCHR
dalabase.
40. InlernaI LiIIy Documenls al Iorsylh TriaI ReveaI KnovIedge of VioIenl and SuicidaI
Tendencies, on CCHR dalabase, aum HedIund Lav Cororalion Time-Line ciling exhibils Iorsylh vs IIi LiIIy
RiiiiNcis
civiI suil, Nov. 1990.
41. Dave AIlimari, Memos DisIay Drug Iirms Olimism OciaIs Were Condenl IDA WouId ack Them On
Suicide, VioIence Issues InvoIving IaxiI, Irozac, Harlford Couranl, 21 Sel. 2003.
42. aum HedIund Lav Cororalion Time-Line ciling exhibils Iorsylh vs IIi LiIIy civiI suil, Nov. 1990.
43. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI suil Nov. 1990.
44. LiIIys Iroducls said lo have baIIasl, Chemical Marketing Reporter, 30 }uIy 1990.
45. Nev York Iav rm seeks cIass-aclion Iiligalion againsl LiIIy concerning Irozac aIIegalions, Indianapolis
Business Journal, 30 }uIy 1990. LiIIy Wilhdravs Lovan ArovaI AIicalion, Marketleer, 21 Nov. 1994.
47. Irakash Marsand, M.D., el aI, SuicidaI Idealion ReIaled lo IIuoxeline Trealmenl, The New England Journal
of Medicine, 7 Ieb. 1991
48. LiIIy Seeks Melhods lo Irevenl Suicide, The Indianapolis Star, 20 Ocl. 1991.
49. Roberl King, M.D., el aI, Imergency of SeIf-Deslruclive Ihenomena in ChiIdren and AdoIescenls during
IIuoxeline Trealmenl, Journal of the American Academy of Child and Adolescent Psychiatry, Mar. 1991.
50. Whal made lhem do il` ABC News Prime Time, 9 May 1991.
52. aum HedIund Lav Cororalion Time-Line ciling exhibils in lhe Iorsylh vs IIi LiIIy civiI Iavsuil,
Nov.1990.
53. Documenls oblained by CCHR lhrough IOIA.
54. Irozac, Townsend Leer for Doctors, Ieb./Mar. 1993.
55. Irozac Iues, Indianapolis News, 18 }une 1991.
56. TaIk Iaer, IDA, 1 Aug, 1991.
57. Time lrack on anlideressanls, CCHR dalabase.
58. IauI A. David, R.Ih., Consumer Safely Ocer, IDA Minules of Meeling re: Irozac Meeling heId 8
Augusl, 1991, memo vriuen 9 Augusl and revised 13 Aug. 1991.
59. Gary NuII, Townsend Leer for Doctors, Irozac, IIi LiIIy and lhe IDA, Ieb-Mar. 1993.
62. Amy Linn, Whal Irice Sanily` The Seale Times, 19 Ar. 1990. Leuer lo lhe edilor, Los Angeles Herald-
Examiner, 3 May 1989, Dangerous Medicine, So vhal if lhe seedu al lhe IDA is uuing oisons on harmacy
sheIves` Congress doesnl vanl lo knov, The American Prospect, 23 Sel. 2002.
63. }oseh GIenmuIIen, M.D., Prozac Backlash, (Simon & Schusler, NY, 2000), . 228-229.
64. Anlhony }. RolhschiId, M.D., and CaroI A. Locke, M.D., Reexosure lo IIuoxeline Aher Serious Suicide
Auemls by Three Ialienls: The RoIe of Akalhisia, Journal of Clinical Psychiatry, Dec. 1991.
65. IAXILS NON HAIT IORMING STATIMINT CHALLINGID GINGKO QUISTIONID, ABC News, 21
Aug. 2002.
66. ig Leldovn`,Lavsuils charge lhal quiuing lhe ouIar anlideressanl IaxiI coId lurkey can cause
lerrifying symloms, People Magazine, 12 May 2003, Direcl-To-Consumer-Drug Adverlising, Food and Drug
Law Journal, VoI. 57, No. 3, 2002, IveIyn IringIe, TeenScreenNormaI Kids LabeIed MenlaIIy III, Scoop, 2 Aug.
2006.
68. 84 sue harmaceulicaI comany IIainlis cIaim IaxiI caused reaclions, State-Times/Morning Advocate
(alon Rouge, LA.), 28 }une 2003.
69. Irozac: ChiId Abuse, CCHR Reorl, 1994.
71. David KessIer, M.D., Inlroducing MIDWalch, A Nev Aroach lo Reorling Medicalion and Device
Adverse Iecls and Iroducl IrobIems, The Journal-of the American Medical Association, 2 }une 1993.
72. IDA Drug Adverse Reaclion Reorls for Irozac, Augusl 1993, on Ie vilh CCHR InlernalionaI.
73. }AMA, November 10, 1993, VoI. 270, No. 18, ciled in CCHRs 1994 reorl, Irozac: ChiId Abuse.
75. Herb Kulchins and Sluarl A. Kirk, Making Us Crazy: The Psychiatric Bible and the Creation of Mental Disorders,
(The Iree Iress, Nev York, 1997), . 13.
(The Iree Iress, Nev York, 1997), . 49, 248, ciling DSM-IV . xxvii.
77. Dr. David HeaIy, The IIuoxeline and Suicide Conlroversy: A Reviev of lhe Ividence, CNS Drugs, 1 (3)
1994, . 223-231.
(The Iree Iress, Nev York, 1997), . 49.
83. IveIyn IringIe, Drug Prots, Fraud and Death: Big Pharmas Big Graveyard, Counlerunch, 26 }une 2006.
84. Documenls: Irozac use reorls more IikeIy lo Iisl suicide, CNN. 4 }an. 2005, }oseh GIenmuIIen, M.D.,
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85. IveIyn IringIe, Drug Prots, Fraud and Death: Big Pharmas Big Graveyard, Counlerunch, 26 }une 2006.
87. Chrisloher Snovbeck, Kids and Deression: Doclors rescribing Drugs for ChiIdren as Young as 3,
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88. }acqueIine A. Sarks, Ih.D. & arry L. Duncan, Isy.D., The Ilhics and Science of Medicaling ChiIdren,
Cenler for IamiIy Services, IaIm each Counly & IIorida Inslilule for lhe Sludy of Theraeulic Change.
89. AAI, Warning on nev drugs lo ghl deression Hobard Mercury, 20 AriI 1995.
90. KeIIy OMeara, Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills that Kill, (AulhorHouse,
2006,) g. 117.
93. Ibid.
94. Gardiner Harris, Warnings CaIIed LikeIy on Suicide Drug Risk, The New York Times, 24 Sel. 2007.
95. IIizabelh Shogren, Lavmakers Take IDA lo Task on Anlideressanls, Los Angeles Times, 24 Sel. 2007.
96. Arianna Hunglon, AnlideressanlsAs Dangerous as Guns` The New York Post, 8 May 1999.
97. Drug Maker WilhheId IaxiI Sludy Dala, ABC News, 9 Dec. 2004.
98. DTC Ads Linked lo Rise in Drug Scrils for Teens, Psychiatric Times, Ar. 2006, VoI. XXIII, No. 4.
99. Chrisloher RovIand, Irisl urges rms lo cIean u lheir acl, The Boston Globe, 2 }uIy 2005, IubIic Cilizen,
Rx R&D Mylhs: The Case Againsl The Drug Induslry, R&D Scare Card, }uIy 2001, g. 20-21.
102. Dave AIlimari, Memos DisIay Drug Iirms Olimism OciaIs Were Condenl IDA WouId ack Them
On Suicide, VioIence Issues InvoIving IaxiI, Irozac, Hartford Courant, 21 Sel. 2003.
103. Diagnosis and Trealmenl of Auenlion Decil Hyeraclivily Disorder, National Institutes of Health
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104. WiIIiam GIasser, MA, 101 Reasons lo Avoid RilaIin Like lhe IIague, (Nurtured Hearts Publications, 2005,) .
82.
105. KeIIy Ialricia OMeara, A Dierenl Kind of Drug War, Insight Magazine, Washington Times, 13 Dec. 1999.
106. Shankar Vedanlam, AD RefueIs Debale Over Severe IMS Disorder, Los Angeles Times, 21 May 2001.
107. KeIIy Ialricia OMeara, MisIeading Medicine, Insight, 30 Ar. 2001.
108. AIison ass, Drug Comanies Inrich rovn Irofession, The Boston Globe, 4 Ocl. 1999.
109. }oshua KendeII, el aI, TaIking ack lo Irozac, David HeaIy The Boston Globe, 1 Ieb. 2004.
110. A reorl on lhe use of sychialric medicalions and lheir eecls, Truchoe NulrilionaI Suorl Lld., 23
}uIy 2003, . 5, ciling M. Gouerchio, el aI., Anlideressanl medicalion use on breasl cancer, American Journal of
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111. Drug-induced nighlmares, AuslraIian Theraeulic Goods Adminislralion (TGA,, Adverse Drug Reactions
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112. Mr. Lavrence Smilh leslimony before lhe Michigan Slale LegisIalure, circa 2001.
113. Ieler reggin, IaxiI WilhdravaI Suil ResoIved, Breggin website, 2002.
114. Irica Goode, Leading Drugs for Isychosis Come Under Nev Scruliny, New York Times, 20 May 2003.
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116. }une Raine, Direclor of Iosl-Licensing of lhe UK Medicines ConlroI Agency, Re SSRIs and lhe risk of
suicide, 8 }une 2001.
117. O. cil., }oseh GIenmuIIen, M.D., . 8.
118. Ibid.
119. Anli-deressanl addiclion varning, BBC News, 11 }une 2001.
120. Shankar Vedanlam, AD RefueIs Debale Over Severe IMS Disorder, Los Angeles Times, 21 May 2001.
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123. Ieler reggin, IaxiI WilhdravaI Suil ResoIved, Breggin website, 2002.
124. Gardiner Harris, Anlideressanl Sludy Seen lo ack Ixerl, The New York Times, 20 Aug. 2004.
125. Shankar Vedanlam, Againsl Deression, a sugar iII is hard lo beal, IIacebos Imrove Mood, Change
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126. KeIIy Ialricia OMeara, Money and Madness, Insight Magazine, 3 }une 2002.
127. Karen arlh Menzies, IreambIe lo lhe IDA RuIe: IDAs Lalesl Iorl lo Immunize Drug Manufaclurers
from Torl LiabiIily al lhe Ixense of lhe Consumer, MeaIys Imerging Drugs and Devices, 16 Ieb. 2006.
128. KeIIy Ialricia OMeara, MedicaI Research lo Die Ior, Insight Magazine, 15 Ocl. 2002.
129. Zyrexa Nevs arlicIes, azyrezaauorneyforyou.com., 21 Mar. 2004.
130. Anna WiIde Malhevs, IDA WiII Seek lo Revise Anlideressanl LabeIs for Youlh, The Wall Street Journal,
20 Aug. 2004, Gardiner Harris, Anlideressanl Sludy Seen lo ack Ixerl, The New York Times, 20 Aug. 2004.
131. UnubIished dala reverses risk-benel of drugs, New Scientist, 23 AriI 2004.
132. Gardiner Harris, Anlideressanl Sludy Seen lo ack Ixerl, The New York Times, 20 Aug. 2004.
133. Dearlmenl of HeaIlh Iress ReIease, Seroxal Musl Nol e Used Ior Trealmenl of ChiIdren, 10 }une 2003,
SIov on lhe Ulake, South China Morning Post, 2 Aug. 2003.
134. U.S. Iood and Drug Adminislralion, IDA Slalemenl Regarding lhe Anli-Deressanl IaxiI for Iedialric
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135. Never Anlideressanls Can Harm Nevborns, Connecticut Post, 15 }uIy 2003.
136. Veronique MandaI, Anli-deressanl: Ielilion largels Wyelhs Iexor, Users vanl ubIic lo knov side
eecls, Windsor Star, Sel. 12, 2003, Sharon Kirkey, Drug may make youlhs suicidaI, doclors varned, Number
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137. IDA: Anlisycholic drugs, diabeles Iinked, Associated Press Online, 18 Se. 2003.
138. Dave AIlimari, Memos DisIay Drug Iirms Olimism OciaIs Were Condenl IDA WouId ack Them
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139. Id SiIverman, SaIes res loId nol lo divuIge IaxiI dala: Drug maker memo ciled risks lo youlh, New
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140. Zyrexa Nevs arlicIes, azyrezaauorneyforyou.com., 21 Mar. 2004.
141. }erey R. Lacasse and }onalhan Leo Serolonin, lilIed, Deression: A Disconnecl belveen lhe
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143. KeIIy OMeara, Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills that Kill, AulhorHouse, 2006.
144. }oe arlon, Chairman, U.S. House of Reresenlalives, Commiuee on Inergy and Commerce, vebsile, 24
Mar. 2004.
145. IDA IsychoharmacoIogicaI Advisory Commiuee Hearing inlo edialric anlideressanl use and
suicidabiIily, leslimony by Dr. Andfrev MoshoIder, 2 Ieb. 2004.
146. Anlideressanl Slrenglhened Warnings Aboul Iedialric SuicidaIily Risk Needed ImmedialeIy, Cmle.
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148. arlon, Greenvood Seek Info Irom IDA On Anlideressanls, Rep. Bartons website, 24 Mar. 2004.
149. }oyce Hovard Irice, Anlideressanl Us by IreschooIers Rising, The Washington Times, 3 Ar. 2004.
150. Zyrexa Nevs arlicIes, azyrezaauorneyforyou.com., 21 Ar. 2004.
151. David IheIs, }udge denies Izers molion lo dismiss ZoIoh Iavsuil, Star Tribune, 21 }uIy 2005.
152. Silzer Turns his Guns on GIaxo Over IaxiI ChiId Suicide Sludies, Independent, 3 }une 2004.
153. KeIIy OMeara, Psyched Out, How Psychiatry Sells Mental Illness and Pushes Pills that Kill, (AulhorHouse,
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154. arry Meier, Ior Drug Makers, a Dovnside lo IuII DiscIosure, The New York Times, 23 May 2007.
155. Anna WiIde Malhevs, IDA IIan WouId Aid Drug Makers in LiabiIily Suils, The Wall Street Journal, 14
}an. 2006.
156. Anna WiIde Malhevs, IDA WiII Seek lo Revise Anlideressanl LabeIs for Youlh, The Wall Street Journal,
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157. IDA, drugmakers fauIled over secrecy, Lavmakers say cruciaI dala on lhe eecliveness of
anlideressanls in lrealing kids vas vilhheId, Denver Post, 10 Sel. 2004.
158. Gardiner Harris, Lavmaker Says I.D.A. HeId ack Drug Dala, The New York Times, 10 Sel. 2004.
159. IIizabelh Shogren, Suicide Risk lo ChiIdren Armed, Los Angeles Times, 14 Sel. 2004.
160. Susan Slefan, Cenler for IubIic Reresenlalion, Torl Liligalion Againsl IharmaceulicaI Comanies
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162. Gardiner Harris, Warnings CaIIed LikeIy on Suicide Drug Risk, The New York Times, 24 Sel. 2007.
163. IIizabelh Shogren, Lavmakers lake IDA lo Task on Anlideressanls, Los Angeles Times, 24 Sel. 2007.
164. Theodore A. Henderson, M.D., Ih.D., Malrix ADHD CIinic, NeurobehavioraI Research, Keilh Holman,
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165. }ason Calo, As lriaI nears, defense leam in Iiuman case grovs by lhree, The Herald (Rock HiII, S.C.), 12
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166. }eanne Lenzer, IDA aneI urges bIack box varning for anlideressanls, British Medical Journal, 25 Sel.
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167. Chris Cuomo, Irime Time Live, ABC News, 9 Dec. 2004.
168. Documenls: Irozac use reorls more IikeIy lo Iisl suicide, CNN. 4 }an. 2005.
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170. Shankar Vedanlam, Drugs Raise Risk of Suicide,AnaIysis of Dala Adds lo Concerns On Anlideressanls,
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171. IhiIi S. Wang, M.D., Dr.I.H., Sebaslian Schneeveiss, M.D., }erry Avorn, M.D.,
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172. IeoIe Magazine, 11 }uIy 2005.
173. Dr. Mark Gra, inlerviev, CBS Studio 2, }uIy 2005.
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175. AIerl for HeaIlhcare IrofessionaIs DuIozeline hydrochIoride (markeled as CymbaIla). IDA, 30 }une 2005.
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179. David IheIs, }udge denies Izers molion lo dismiss ZoIoh Iavsuil, Star Tribune, 21 }uIy 2005.
180. }e Svialek, Uncerlainly vas Driver in Zyrexa DeaI, IndianapolisStar.com, 11 }une 2005.
181. Ivar Aursnes, Ingunn Iride Tvele, }orund Gassenyrm enl Nalvig, Suicide auemls in cIinicaI lriaIs vilh
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183. Sludy: Nev drugs IiuIe beuer for schizohrenia, St. Petersburg Times, 20 Sel. 2005.
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