Ethical Issues in Pharmacogenomics Modified

7/23/2019 Ethical Issues in Pharmacogenomics Modified

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Condition Efficacy Rate (%)

Analgeic (Co!2) "0

#eeion (&&R') 62

Ata 60

Cadiac aytia 60

#ia*ete +7

,igaine (acte) +2

,igaine (oyla!i) +0

C/ 47

Aleie 30

ncology 2+

T" Pro$%## o- P"ar$acogno$%c#

Mor 4c!%( $d%ca!%on#

F1r #%d 4c!# Fa#!r and c"a/r cl%n%cal !r%al#

5R#cu6 drug#

DR7G

DEVE3OPMENT

89+8: 'ar#

7/ !o ;<99&999&999 ac"

Ba#%c B%o!"%c#

• T1o /rdo$%na! /"%lo#o/"%# go(rn%ng !"%c# %n !"W#!rn 1orld=

– Don!olog%cal (%1+ I> an! )8@*+8<9*.

– 7!%l%!ar%an%#$+o"n 3ock )8,+8@9*. and o"nS!uar! M%ll )8<9,+8<@.



Don!olog'7!%l%!ar%an%#$

• Don!olog' – T" #!ud' o- du!%#& r#/on#%0%l%!%# !"a! /r#on#

"a( !o1ard on ano!"r>

• 7!%l%!ar%an%#$ – T" (%1 !"a! ac!%on# or /ol%c%# ar !o 0

$orall' (alua!d accord%ng !o !" !n! !o

1"%c" !"' /ro$o! "a//%n## or 1ll+0%ng>

WARFARIN



• Blood !"%nnr %# /r#cr%0d $or !"an 9M%ll%on !%$#ac" 'ar>

• I! accoun!# -or *M Ad(r# drug (n! ac" 'ar)#cond onl' !o %n#ul%n.>

• Po/l 1%!" a (ar%an! o- !" gn# CYPC or VORC8)(%!a$%n /o%d rduc!a#. 0rak do1n !" drug$or #lo1l'& 1"%c" $an# !"a! %! #!a'# %n !" 0od'longr and cau## 0ld%ng>

• In 99@& !" FDA announcd !"a! a n1 la0l %# 0%ngru%rd -or War-ar%n& 1"%c" #!a!#& undr

/rcau!%on#= Cr!a%n (ar%a!%on# %n !1o k' gn#$a' %ncra# !" nd -or $or -run! $on%!or%ngand !" u# o- lo1r do##>

• FDA /roc!# !"a! 1%d#/rad u# o- gn!%c !#!%nga# /ar! o- /r#cr%0%ng could a(o%d <:&999 #r%ou#0ld%ng (n!# and 8@&999 #!rok#& #a(%ng a0ou!;8>8B annuall'>

• T" gn!%c !#! co#!# ;99+;:99>• Turnaround !%$ -or !#!# can 0 a# $uc" a# 89 da'#>• On Ma' *& 99& FDA announcd %! 1%ll no! /a' -or

!" !#!# 0cau# o- a lack o- (%dnc o- cl%n%calu!%l%!'>

coun!r%#>

Or/"an Gno!'/#I- a cond%!%on %# #u2c%n!l' rar& %! 1ould no! $akcono$%c #n# -or a $anu-ac!urr !o %n(#! %nd(lo/%ng a !arg!d !"ra/u!%c %# calld an or/"angno!'/>

Or/"an Drug

T" Or/"an Drug dJn# an or/"an drug a# ona4c!%ng -1r !"an 99&999 /r#on# %n !" 7>S>&



and %! g%(# %ncn!%(# )>g> !a %ncn!%(#. !oco$/an%# !o d(lo/ drug# -or !"# d%#a##>

T"r S"ould 0 co$/ara0l lg%#la!%on -or or/"angno!'/#5>

Acc##

N1 /"ar$acogno$%c+0a#d drug# ar l%kl' !o 0 $or/n#%( !"an o!"r $d%ca!%on# K cr!a%nl' $or!"an o4+/a!n! gnr%c drug#> W"o 1%ll "a( acc##!o !"# /roduc!#?

T"# drug# #"ould 0 $ad

Ea#%l' acc##%0l !o /oor /o/l %n

Poor coun!r%#>

Rac+Ba#d Md%ca!%on#E!"%cal I##u# Ra%#d 0' B%D%l

B%D%l %# a co$0%na!%on o- drug# !"a! "a( 0na(a%la0l %n gnr%c -or$ -or dcad#= "'dralaL%n and%#o#or0%d)n%!rogl'cr%n.>

I! 1a# /o#!ula!d !"a! !"%# co$0%na!%on o- drug# 1ould0nJ! %nd%(%dual# 1%!" nd+#!ag card%o(a#culard%#a#>

In 8@& !" FDA rc!d !" drug a-!r a !r%al %n a$%d rac grou/& al!"oug" a #u0grou/ o- A-r%canA$r%can #u0c!# a//ard !o #"o1 0nJ!>

Mdco !"n #old %!# r%g"!# !o B%D%l !o N%!ro$d& Inc>

A-r%can A$r%can# ar $or l%kl' !o "a( dcra#d l(l#o- n%!r%c o%d& and B%D%l %# a n%!r%c o%d n"ancr>

T"%# 1a# !" 0%olog%cal "'/o!"#%# -or an %$/ro(dou!co$ %n !"%# #u0/o/ula!%on>

N%!ro$d o%nd 1%!" !" A##oc%a!%on o- BlackCard%olog%#!# !o #/on#or !" A-r%can A$r%can Har!



Fa%lur Tr%al& 1"%c" %n(ol(d 8&999 /a!%n!# a! 8@9#%!#>

On ul' 8& 99*& !" !r%al 1a# "al!d 0cau# o- !"#%gn%Jcan! #ucc## o- /a!%n!# nrolld %n !"!ra!$n! ar$o- !" !r%al>

R#ul!#=

* %$/ro($n! %n #ur(%(al

and

rduc!%on %n Jr#! "o#/%!al%La!%on>

A /a!n! 1a# %##ud -or B%D%lon Augu#! 8& 99*>

On Dc$0r & 99*& a n1 drug a//l%ca!%on 1a##u0$%!!d !o !" FDA %n 1"%c" a//ro(al 1a# #oug"!onl' -or A-r%can A$r%can /a!%n!#>

A//ro(al 1a# gran!d& un & 99:>

Research on Vulnerable Populations

So$ gn!%c !ra%!# "a( a "%g"r -runc' a$ong#u0/o/ula!%on# #oc%all' dJnd 0' rac or !"n%c%!'>Ind%(%dual gn!%c (ar%a!%on# ar no! d%#!r%0u!d uall'!"roug"ou! !" /o/ula!%on 0cau# o- ndoga$'&$%gra!%on& gogra/"%c %#ola!%on& -oundr 4c!& gn!%cdr%-!)rando$ c"ang %n !" -runc' o- a gn %n a #$all%#ola!d /o/ula!%on.& and o!"r /r%nc%/l# o- /o/ula!%ongn!%c#>

Vulnra0l Grou/#

An %ncra#d r%#k o- an und#%ra0l "al!" cond%!%on %#a##oc%a!d 1%!" a /ar!%cular /o/ula!%on grou/& #/c%all'1"n !" grou/ %# a rac%al or !"n%c $%nor%!' %n a #oc%!'>

T"# grou/# ar #a%d !o 0 5(ulnra0l>6

Ethical Issues in Pharmacogenomics Modified

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