2

3
BY
CHRIS
SWEENEY
BIG PHARMA
WANTS TO
TAKE YOU
FOR A RIDE
ILLUSTRATION BY
YUKO SHIMIZU
usan and Brcndan had bccn
dating for a month whcn
thcy dccidcd to spcnd a
wcckcnd togcthcr in Ncw
York. Thcy had mct in
Fas Church, Virginia, and
whic Susan was not com-
pctcy sod on Brcndan,
sncaking around thc officc
and having a quickic in thc copy
room kcpt hcr intcrcstcd. As thcy
unpackcd thcir bags and scttcd into a
dingy hotc on thc Lowcr East Sidc, thc
tcnsion that had mountcd during thcir
fivc-hour drivc snappcd.
Thc coupc dovc into bcd with thc
cagcrncss that accompanics a ncw rca-
tionship. But thc much-anticipatcd
scssion pctcrcd out in two minutcs,
bcforc Susan coud cvcn warm up.
What thc fuck is wrong with you. shc
askcd as Brcndan rocd off hcr. This
markcd at cast thc fifth timc in thcir
rcationship that Brcndan had cacu-
atcd too quicky for Susan's iking, and
dcspitc thc fact that hc aways countcrcd
with a good munch, hcr paticncc had
pcakcd. Brcndan rctrcatcd downstairs
for a cigarcttc, wishing to avoid furthcr
intcrrogation.
Js thcrc somcthing wrong with Brcn-
dan. Jt dcpcnds on whom you ask.
Thc prospcct of a scx-ficd vacation
may havc put him in a statc of anxi-
cty that was manifcstcd in this scxua
shortcoming. Or Brcndan may bc
gcncticay prcdisposcd to havc a
ow cacuatory thrcshod, posscss-
ing a hypcrscnsitivc pcnis that cts
him ast ony a fcw minutcs. Jt may
bc that thc cascadc of dopaminc,
scrotonin, oxytocin and othcr
ncurochcmicas is at faut. Somc
woud suggcst Brcndan's cary
cacuation coud bc inkcd to how
hc masturbatcs or is cmbcddcd in
his pubcsccnt scxua cncountcrs. Or,
of coursc, thcrc is aways thc possibi-
ity that nothing is wrong with Brcndan,
that Susan's cxpcctations ust don't aign
with his capabiitics for impromptu
intcrcoursc.
Susan's postcopuatory inquiry into
what thc fuck was wrong took Brcndan
down a notch, and thcir tryst fizzcd out
soon aftcr. Mcn with rapid cacuation
worry thcir partncrs wi cavc thcm,
and thc addcd anxicty ust makcs thc
condition worsc.
Scx is highy variabc. A 200b study
pubishcd in 1/s journa| oj Ssvua| MsJ||ns
uscd stopwatchcs to mcasurc intravagina
cacuation atcncy, or how ong a man
asts from thc start of intcrcoursc unti
cacuation. Thc study ookcd at b00 cou-
pcs and rcvcacd a mcdian timc of b.4
minutcs. Thc duration of thc mcn-who
wcrc rccruitcd from thc L.S., thc L.K.,
Turkcy, Spain and thc Ncthcrands-
rangcd from undcr a minutc to about
4b minutcs. Thc avcragc timc varicd
for cach country, with thc Turks com-
ing first at 3.7 minutcs. Condoms had no
impact on thc avcragc timc, and bcing
circumciscd yicdcd an insignificant
bcncfit. Anothcr study, aso pubishcd
in 200b in 1/s journa| oj Ssvua| MsJ||ns,
rcvcacd a mcdian timc of 7.3 minutcs
among 1,380 L.S. mcn not considcrcd
to havc cacuation difficutics. Thc study
aso incudcd 207 mcn considcrcd to bc
prcmaturc cacuators, who cockcd an
avcragc timc of 1.8 minutcs.
Prsma/urs sjau|a/|on is a tcrm cvcryonc
has hcard but fcw can dcfinc bcyond thc
obvious whcn a guy comcs too cary.
A taboo ooms ovcr thc issuc, with most
convcrsations rccgatcd to punch incs
or dcnsc mcdica itcraturc. To bc fair,
bcforc thcrc was ED thcrc was impo-
tcncc, and that wasn't a choicc taking
point cithcr.
Dctcrmining what constitutcs thc
condition has rcccnty bccn opcn to
incrcasing dcbatc. Js it thc inabiity to
ast morc than a prcdctcrmincd timc.
Js it not bcing abc to rccognizc whcn
cacuation wi occur.
Thc focus on crcating a univcrsa dcfi-
nition of primary prcmaturc cacuation
is drivcn in part by thc pharmaccuti-
ca industry's intcrcst in scing drugs
that makc a man ast ongcr. |ohnson
& |ohnson's drug for cary cacuation,
dapoxctinc, is approvcd in a handfu
of ovcrscas markcts undcr thc brand
namc Priigy. Thc drug, rccctcd by thc
FDA in 200b, has bccn shown to cad to
a thrccfod incrcasc in duration whcn
takcn in a 60-miigram dosc about an
hour bcforc scx. Dapoxctinc is a sccc-
tivc scrotonin rcuptakc inhibitor, as arc
thc antidcprcssants Prozac and Paxi. A
wc-known sidc cffcct of most SSRJs is
dcaycd cacuation, cading many doc-
tors to prcscribc thcm to mcn in nccd of
a fcw cxtra thrusts. Lsing a sidc cffcct of
a drug to trcat a condition for which thc
drug is not approvcd is hardy idca, but
no FDA-approvcd trcatmcnt cxists.
Shionogi is a |apancsc pharmaccuti-
ca company bascd in Osaka. Jt rcccnty
wrappcd up Phasc JJJ studics-thc ast
and argcst stagc of tcsting, whcn a drug
is comparcd with othcr trcatmcnts-
on an cxpcrimcnta compound dubbcd
PSDb02. Thc drug is a combination of
thc topica ancsthctics idocainc and
priocainc and is spraycd on thc hcad
of thc pcnis a fcw minutcs bcforc scx.
Jn studics of about 1,000 mcn and thcir
fcmac partncrs, PSDb02 proongcd thc
point of no rcturn from an avcragc of
0.6 minutcs to 3.3 minutcs. Thcrc is
nothing novc about using drugs to
dcscnsitizc thc ncthcr rcgions, but
most such drugs arc crcams, and rub-
bing crcam on thc pcnis of a man who
is trying to ast ongcr sccms i-adviscd.
Dr. Donad Manning, Shionogi's chicf
mcdica officcr, says thc spray appcars
to rcducc scnsation without numbing
thc pcnis-aways a good thing if you
actuay want to cnoy scx-pointing
out that fcwcr than two pcrccnt of mcn
who uscd it rcportcd numbncss.
t
Thc pharmaccutica industry's intcrcst
in scrving a vast markct of prcmaturc
cacuators isn't thc ony factor bchind
argumcnts about how thc condition
shoud bc dcfincd. 1/s D|agnos/|
anJ S/a/|s/|a| Manua| oj Msn/a| D|s-
orJsrs, thc Amcrican Psychiatric
Association's rcfcrcncc tcxt, is
bcing rcviscd for its fifth cdition.
Somc pcopc havc criticizcd thc
DSM's currcnt dcfinition of prc-
maturc cacuation as bcing too
subcctivc. Thc symptoms of PE,
according to thc fourth cdition of
thc DSM, incudc cacuation with
minima scxua stimuation bcforc,
on or shorty aftcr pcnctration and
bcforc thc pcrson wishcs it.
Dr. Robcrt Tayor Scgravcs, profcssor
of psychiatry at Casc Wcstcrn Rcscrvc
Lnivcrsity and a mcmbcr of thc DSM
rcvision panc, says this dcfinition is
so vaguc any numbcr of pcopc can bc
diagnoscd with a probcm. Somc studics
cvcn cassify mcn who ast wc bcyond
fivc minutcs as prcmaturc cacuators.
Jt sounds kind of mcaningcss at
that point, Scgravcs says. Wc
nccd grcatcr prccision.
Thc draft proposa of
thc ncw cdition of thc
DSM rccommcnds
dropping rsma/urs
and rcnaming thc
condition cary
cacuation.
S c g r a v c s
and Michac
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5

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Pcrcman, a Manhattan-bascd psychoo-
gist who is prcsidcnt of thc Socicty for Scx
Thcrapy and Rcscarch, agrcc that rsma-
/urs has a pcorativc connotation. Howcvcr,
Pcrcman-who aso scrvcs as a consutant
for pharmaccutica companics-prcdicts that
in thc futurc it wi ikcy bc known as PE, ust
as crcctic dysfunction is now cacd ED.
A fcw ycars back, Pcthora Soutions, a
L.K.-bascd drug firm, awardcd an unrc-
strictcd grant to thc Jntcrnationa Socicty
for Scxua Mcdicinc to cxporc thc cvidcncc.
A crcw of 21 cadcrs ranging in spcciatics
from psychiatry to ncurouroogy mct in
Amstcrdam in 2007 to prcparc a diagnostic
bucprint for mcn who cacuatc too quicky.
Aftcr wading through thc data, thc cadcrs
cmcrgcd with what is now considcrcd to bc
thc god-standard dcfinition. Thc JSSM's
dcfinition considcrs thc dysfunction to bc
cacuation which aways or ncary aways
occurs prior to or within about onc minutc
of vagina pcnctration, rathcr than simpy
bcforc a pcrson wishcs it to occur.
Thc JSSM, ikc thc DSM, takcs into
account thc strain that PE can pacc on a
man, his partncr and thcir rcationship.
But it is thc onc-minutc bcnchmark-thc
quantitativc cnd point-that may provc vita
in bringing PE drugs to our prcscription-
hungry nation.
Pcthora Soutions' dccision to givc thc
JSSM a grant for a dcfinition was not ust
a gcsturc of goodwi. Pcthora dcvcopcd
thc abovc-mcntioncd cacuation-dcaying
spray, PSDb02, and iccnscd it to Scicc
Pharma, which was atcr acquircd by Shion-
ogi. Shoud Shionogi succccd in bccoming
thc first company to havc an FDA-approvcd
drug for prcmaturc cacuation, Pcthora
coud scc a windfa in royatics. Manning,
Shionogi's hcad mcdica officcr, says thc
company uscd thc onc-minutc bcnchmark
in thc data it cocctcd, as wc as aspccts
of contro and distrcss. Jn fact, data from
thc study show that mcn who wcrc givcn
thc drug rankcd significanty highcr on a
scac of cacuatory contro than mcn givcn
a paccbo.
Shionogi and |&|-which is anayzing its
own dapoxctinc data for a potcntia FDA
rcsubmission-arcn't thc ony drug makcrs
who hopc to crack this markct. Sarah Tcrry,
prcsidcnt of biomcdica data providcr Lifc
Scicncc Anaytics, says about 20 paycrs
arc ooking to gct in. GaxoSmithKinc is
among thcm, with two drugs in dcvcop-
mcnt: onc dcsigncd to inhibit oxytocin and
thc othcr an SSRJ. Both arc in Phasc JJ
tcsting, whcn scicntists dctcrminc if a pro-
poscd mcdication is actuay associatcd with
a thcrapcutic bcncfit.
t
Prcmaturc cacuation is attractivc to
drug companics bccausc it rcprcscnts an
cntircy ncw markct at a timc whcn thcy
nccd to rcpcnish thcir pipcincs with ncw
compounds. Big Pharma is hurting toward a
patcnt ciff, and gcncric companics arc rcady
to pouncc on thc opportunity to churn out
chcapcr vcrsions of Lipitor and Viagra, which
comc off patcnt in 2011 and 2012. Tcrry says
that bctwccn 2008 and 2014, $113 biion
worth of drugs wi havc thcir patcnts cxpirc.
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Thc potcntia of a drug for prcmaturc
cacuation dwarfs that of an crcctic-
dysfunction drug. Estimatcs vary-mainy
bccausc of thc dcfinition issuc and troubc
in dcsigning studics-but bctwccn 20 and
30 pcrccnt of thc popuation coud bc con-
sidcrcd prcmaturc cacuators. Onc markct
study, from Datamonitor, cstimatcs that in
2010 thc L.S. popuation of cary cacuators
bctwccn thc agcs of 20 and b9 is 2b.8 mi-
ion, comparcd with 9.b miion mcn in
nccd of boncr drugs. And that docsn't
incudc ovcrscas markcts. J think thc FDA
is utimatcy wiing to approvc a drug for
prcmaturc cacuation, Tcrry says. Thc
chacngc at this stagc is ust dcfining what
that actuay mcans.
t
Jn thc days of King Charcs JJ, thc ast Span-
ish Habsburg rucr and onc of thc most rcga
prcmaturc cacuators on rccord, scxua dys-
functions wcrc thc product of witchcraft.
Jnnovativc trcatmcnts incudcd cxorcisms
and urinating through your wcdding ring
or thc kcyhoc of thc church whcrc you wcrc
marricd. Fast forward to thc cary 20th ccn-
tury and you' comc across a sca of crotic
snakc oi, incuding an arscnic-containing
cixir in Dr. Frank Micr's 1913 tomc, Domss-
/| MsJ|a| Pra/|s. Jn thc atc 19b0s, in thc
wakc of Kinscy camc thc work of Wiiam
Mastcrs and Virginia |ohnson, bcttcr known
as Mastcrs and |ohnson. Thc duo dcvcopcd
thc sti popuar squcczc tcchniquc to pro-
ong scx, which, as its namc impics, invovcs
putting a strangchod on thc hcad of thc
pcnis bcforc cacuation. Studics havc dcm-
onstratcd its cfficaciousncss, but cvidcncc
suggcsts that without rcguar upkccp thc pos-
itivc cffccts wcar off. Aso, it can bc awkward
to ask somconc you'rc sccping with for thc
first timc to put your dick in a dcath grip.
Mastcrs coudn't do any anaysis-hc
didn't havc any funding-so what hc did was
hirc prostitutcs to obscrvc thcm, intcrvicw
thcm, idcntify how thcy had scx and what
thc scxua issucs of thcir ivcs wcrc, says Dr.
Jrwin Godstcin, dircctor of scxua mcdicinc
at Avarado Hospita in San Dicgo. God-
stcin, who was an acquaintancc of Mastcrs's,
notcs that thc atmosphcrc surrounding scx-
ua rcscarch was so rcstrictivc in thc cary
days of his work that Mastcrs struggcd to
gct mcdica tcxts about fcmac rcproductivc
anatomy. Thc thing is, prostitutcs saw a ot
of mcn who wcrc anxious and strcsscd, so
his formuations wcrc madc on bad obscr-
vations bccausc of popuation bias. Jt was
thcir thcory, which is pcrpctuatcd cvcn in
2010, that 90-pus pcrccnt of a scxua prob-
cms arc duc to psychoogica issucs: anxicty,
humiiation, fcar, dcprcssion.
Godstcin is cditor-in-chicf of thc 1/s
journa| oj Ssvua| MsJ||ns (and aso a drug
company consutant). For morc than 20
ycars hc was fundcd by thc Nationa Jnsti-
tutcs of Hcath to study scxua function and
dysfunction. Hc is highy critica of thosc
who bcicvc such disordcrs arc rootcd socy
in psychoogy. Whcn hc tcs you about a
man who can't watch his wifc strip down
without cacuating a ovcr himscf or about
a 28-ycar-od guy who hasn't had an crcc-
tion for morc than a dccadc bccausc of a
damagcd artcry, you carn how dcbiitating

8
scxua dysfunction can bc.
For Godstcin, thc work of a Bayor Lni-
vcrsity uroogist, F. Brantcy Scott, was thc
catayst that took thc trcatmcnt of scxua
dysfunction from thc hcad doctors and
brought it into thc mcdica ficd. Jt had to
cnd up in a physician's hands to progrcss
aong mcdica thinking and diagnostics, hc
cxpains. Scott, who dicd in a panc crash in
1991, paycd an instrumcnta roc in dcvc-
oping thc infatabc pcnic prosthcsis, which
has bccn uscd to trcat tcns of thousands of
paticnts. Thc dcvcopmcnt of this surgicay
impantcd dcvicc transformcd thc andscapc
of rcscarch and opcncd thc ficd of scxua
mcdicinc. Prcmaturc cacuation, Viagra,
orgasm dysfunction, a this stuff cndcd up
in thc ficd of uroogy, says Godstcin.
By now an array of drugs-incuding
ncurocptics, tricycic antidcprcssants, opi-
oid agonists, phosphodicstrasc inhibitors,
sympathoytics and SSRJs-havc had thcir
cffccts on cacuation studicd by pharma-
ccutica cnginccrs. Bcyond drugs, modcrn
rcscarchcrs havc tcstcd rings that wrap
around thc pcnis, bchaviora tcchniqucs
such as thc stop-start approach and cvcn
virtua-rcaity programs intcndcd to hcp
mcn cxporc thcir scxua dcvcopmcnt for
cvcnts that might havc infucnccd thcir cac-
uatory rcfcx. Much rcmains to bc carncd
about thc mcchanisms of cacuation, but
rcscarch bostcrs thc notion that it is rootcd
in ncurochcmica intcractions.
Thcrc arc pcopc who nccd hcp, and wc
havc to bc scnsitivc to thcir nccds and not bc
rigid, says Godstcin, who dirccts paticnts
to buy dapoxctinc from oninc pharmacics
in forcign countrics-a proccss no morc
compicatcd than ordcring a book from
Amazon.com.
t
Numcrous chacngcs oom ovcr thc suc-
ccss of any drug, and for onc that cxtcnds
intcrcoursc thc most significant factors wi
bc pricing and pcrccption. Bccausc prc-
maturc cacuation is in such a broad rangc
of paticnts and docsn't havc a corrcation
with agc, it is actuay much morc in inc
with a ifcstyc drug, says Tcrry of Lifc
Scicncc Anaytics. Bccausc it wi bc a ifc-
styc drug, it won't bc rcimburscd by hcath
insurancc. Pcopc wi havc to pay out of
pockct for it.
Gctting mcn to schcduc an appointmcnt
to tak about an ostcnsiby cmbarrassing dis-
ordcr and thcn pcrsuading thcm to cough
up moncy for trcatmcnt wi rcquirc a costy
dispay of advcrtising acumcn. Thc battc
ovcr dircct-to-consumcr advcrtising is noth-
ing ncw, with onc sidc considcring it paticnt
cducation and thc othcr considcring it a
too of dcccption. Such drug ads arc amost
cxcusivc to thc L.S., coming to thc airwavcs
ony in thc 1990s. Thc stakcs arc now hugc:
Pfizcr rccruitcd thc ikcs of Bob Doc, Rafac
Pamciro and NASCAR drivcr Mark Mar-
tin to pitch Viagra. Ei Liy's ad for Ciais
that fcaturcs a coupc in scparatc bathtubs
gazing toward thc horizon has bccn citcd
by Nicscn as onc of thc most rcmcmbcrcd
commcrcias. As thc crcction markct grcw
and compctition incrcascd, thc ads bccamc
morc risqu, sparking compaints and FDA
warnings that thc drugs wcrc bcing hawkcd
9
as party pis. Jt is unccar how Amcrican
houschods wi rcspond whcn copywritcrs
start churning out cuphcmisms for sjau|a/s,
but chanccs arc thcrc wi bc somc uproar.
Any opposition to such ads wi givc pausc to
drug companics and rcscarch institutcs con-
tcmpating ncw vcnturcs in scxua hcath.
But advcrtising is csscntia for any prc-
maturc cacuation drug. Wc ookcd at thc
cxampcs of Viagra, Lcvitra and Ciais as
a bcnchmark for thc impact of dircct-to-
consumcr advcrtising, says Tcrry. What wc
found quaitativcy is that, aftcr thc aunch
of Viagra, thc markcting of cach subscqucnt
product cxpandcd thc opportunity of thosc
drugs by ncary 1b to 20 pcrccnt cach. Thc
amount of markcting out thcrc continucd
to push thc popuation basc that much cach
timc. A simiar pattcrn wi prcsumaby
cmcrgc with prcmaturc cacuation drugs.
Thc markct wi swc by miions with cach
additiona approva cttcr thc FDA mais.
t
Somc cxpcrts scc thc rca probcm as thc
imposition of normativc structurcs on what
is a variabc phcnomcnon. Dr. Lconorc
Ticfcr, associatc profcssor of psychiatry at
Ncw York Lnivcrsity, is in thc vanguard of
this movcmcnt. Ticfcr docsn't concca hcr
intcntion to undcrminc thc quantification
of scxua function. Shc admits that a drug
to dcay cacuation can bc uscfu to somc
but says thcrc is no such thing as prcmaturc
cacuation, and cfforts to crcatc drugs to
trcat it arc disingcnuous. Scx, Ticfcr says,
is morc ikc dancing than digcstion.
Fundamcntay, bcing fat or thin is a mat-
tcr of ivc variation throughout history and
cuturc, shc says. Thc samc thing is truc of
coming quicky or not, having a hard crcc-
tion whcn you'rc 60 or not, wanting to havc
intcrcoursc whcn you'rc 60 or not. Thcrc's
a grcat dca of variabiity. To try to stuff it
into somc simpcmindcd bottom inc is to
dcny thc rcaity of scx.
Michac Pcrcman, thc Ncw York thcra-
pist, says cacuatory atcncy is ust anothcr
human charactcristic, simiar to buc cycs,
bcst pottcd aong a skcwcd distribution
curvc. Hc woud ikc to scc thc dcfinition of
prcmaturc cacuation dividcd into four cat-
cgorics of scvcrity: whcn a man can't cntcr
thc vagina, whcn scx asts css than a min-
utc, whcn scx asts onc to two minutcs and
whcn it asts two to four minutcs. Pcrcman
rcasons that thc avcragc physician wi scc
pcopc who considcr thcmscvcs to bc suf-
fcring from prcmaturc cacuation who ast
morc than onc minutc but not as ong as
thcy woud ikc to.
Rcmcmbcr that Brcndan was ncaring
two minutcs that night in Ncw York. Wc
don't know if hc cvcr fct in contro, but
distrcss ccrtainy rcarcd its hcad. No doctor
can fuy answcr Susan's qucstion as to what
thc fuck was wrong with Brcndan, and no
drug can addrcss thc undcrying factors that
dctcrminc how ong hc asts on any givcn
occasion.
Jf Brcndan had poppcd a pi that night,
woud hc havc bccn trcating a discasc or
ust cnhancing an aspcct of cvcryday ifc.
Our rcguatory systcm is dcsigncd to wcigh
thc risks and bcncfits of drugs uscd to trcat
dcfincd discascs, not to improvc our ifcstycs.

10
But thc inc bctwccn trcatmcnt and cnhancc-
mcnt is now morc burrcd than cvcr.
Such uscs of pharmaccuticas posc cha-
cngcs for us as a country, says Pcrcman.
Thc chacngc is aways grcatcr whcn wc
tak about scx.
Big Pharma isn't going to shy away from
this convcrsation. Jt's adcpt at dictating
what's good and what's bad and what is
norma and what isn't. Eacuation won't bc
an cxccption.