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PE TE DU PONT FDA:and Our split medical persona.. n.ltulc 22, the 1(NNI and 01)ruti Administration ap- provtYi thc s:dc of Ilivid. also known as 1)1)C, for tltc treatment of AIUS. '1'Itat de- cision was a slcp forwarJ. Iwl if yott Ihink Iho FDA has rcfin'tncJ itscll•, :utd is now on our sido, think again. Antcrican medicine has a split pct:um:dily. In Ihe area of surgical ttwltniquc. wc lead the w(n-Id; Ira- licnls fromabttit td comcloourinlcr- natiun:tlly kn(nvn ntcdicid ccnlcr:t I Ii/r treatment Ilwl is unavailable clscwhcrc. Ilul for medical drugs. Ihcsitualion is Iltcuplwsilc- filr thc ntost advanced pk;u•tnacculic:lls, it is wc who nmsl t;o abr(titd. Whilc ncw (1rut;s canlinuc to bc inn-uduccJ in Illis cnunu'y, thcy arc often available elsewhere years hclin•c. '11tc rc:(sou for this lies uluarcly wilh tltc F1)A. No new drug can hc sold in this cuturtry unless it ntccls PI)As criteria uf safcly and clficacy. 'I'Ita irony is that while FI)A's staur d:nrJs protcct us front dauRcrotls, in- cf/cclivc drttl;s. Ihcy also restrict ot,r acccss lo ncw, needed drugs as wcl1. 9'itc rctildl is "drul;-la{ "-- the Inct th:d llic most :Idv:mccJ new pharmaceuticals ilrc often inlt•+r ductYl first not hcrc but in olhcr cuuntrics, particularly in ('rc:tl IA-it:un.•flrc tral;cdy is that this rcl;- uL•tlury Jilcnnna, initiated in tbc n:unc uf "consumer protcctinn;' at:- colnplishcs just Ihe opposite. '1'he "Jn(g-L•It;" is bul onc cx:un- plc of Ihc :mti-cnnsuwcr :111ititdc dccply cmhcddcJ in Illc ralinualc :md lihilusuphy uf Ihc I'1)A. 'I'lle recenl conlrovcrsy nver tv,nncn's breast itnltlanls is :Inulltct: IAx/klll/; I/ack, wilo klil/ws how iiGiiiy wonicn willt implants were unncccs- s:rrily tcrrifieJ by this sudJcn a(n- notmccmcnl of danger? '1'hc FDA has takcn ulwn itself Iltc decision whcn a tvoman is sufficicntly (lisfif;- urcd to pcrntit brcasl cnlt:utccntrnl. Never mind her Jecision, licr dnc- lol :sadvic^,ur Ihccntuliunal traum:t associated wilh cach individual sil- u:ttinn-Ihc FDA bureaucracy will decide for cach paliati. Itcp. Marilyn Lloyd, 'Icnncsscc 1)cmocrnl, nnlc/I tltnt lilr al least two wrcks lidlinvinl, the FDA rulint; :11- luwing only "to'gcnt necd impl:lnts;' "nol one wont:m Jccntrd wy:cnl nccJ ... rcccived an implant (luc 11) INI)AI hurc:lucralic IanRlcs willt utanufaclurcrs" A third anll even wursc cs:nrplc is Ilic F1)A:s decision rcGarJinl; Ilte use of dclachablc silicunc balluous in nctu•nsurgcry.'1'Itis prnccdurc has been successfully used by surt;cons in hundreJa of cascs, and saved Imn- dreds of livcs, but Ihc FDA dccidcd lhat use of tlic dcvicc would bc lintilcd to 200 p:dicnts in 25 malical centers. The Wall Sb-ccl .lnurnal wrolc uf :t ncurusurgcry case in Ilus- lon where a 75-ycar-old woman dial;- nuscJ to have a golf-sizcd ancurysut, faccd possible blinJncss or cvcn death ttolcss she tvas treated willt Ihc siliconc b:dkKm. Itcmarkably, hcr stu•I;t(nt, an cxpcrl in Ihc usc of lhc balltwn. had In wait firw days to receive Itcrmi%sion f rnnm thc PI tA lo I,o altcad wilh Illc ptrn't.lurc. In Ihal cn.c. Ilvct C w:(. n h:yqry ruduqt. Irol wlly <Iwruld a Imdn-(d'v life Ik• cu n.k Ix:cauxc all (rllCrcial ial W:t%hinrlat tv n Icnctlty lulxh'thdy a Iwr enjoying rc:ulcr:lcy c(N/ld luvl a t•tdc llkc tlt:A. O)e,ll~utgtutt e,i~ttc~ '1'Itcsc problents, front "drug-lal;'• to sttrllicul clcarance, do nol result front tlny particular details in FDA rcgulation, but frrnn its basic ralio- nalc-thc idea thnl a fcJctal agcncy, subjecl to IMtlilic:d mtJ journalistic pressure, csm decide which drugs and medical devices we can and catt- n(/l IIsC. 77tcrc:u•c Iwo Ihintis wrung wilh lhis idea. 'I'Itc I'irsl Ike fallacy ol' lhinkinti that,onas personatl:ut is.euc as individual Ileallh, lhere shuuld be unifin•nt sltnularJs lin• 250 million Americans.'I'he issue is not whether to outlaw snake oil and other sllant pul ions. I'raudulcnl IucJic:d inus, pruntutcd oit Ille basis uf claiuts liu• which 1licrc is no scicntific cvi- dcncc,:u'c easily haudlcJ uudcr IcJ- cral law.'I'hc rcal qu(:sliun coucct'us drugs and devices tllal havc scicuti- fic slqtporl, ltul nul enoutilt Insalisfy Ilte FI)A. Siliconc halknlu sm•1,(:ry is Iitc hcsl examplc. 1'Itc qucsliuo is also tcllingly pnscd re{;:o•Jiul; drugs /in' illncsscs li(r whicll Ithcrc :u'c nn s:tl islaclury cslablishcd U•c:d ntcut s. In such cascs. PUA's current posilinn cuntcs drnan tu tllis: liro nety Ilc dy- ilq; frolu suntc disease. but lin• ynnr uwn prulcctiuu FDA will Qcny ynu access lu cxlrcrilncnl:d Jrugs. Onc nct•d nnl bavc a to rcai- i•r.c lllc mnral tibstn-dily uf "protccl- inR" tcrminally ill paticnls in Iliis nr.tnucr. As uuc canccr resr:lrrkcr put il, "Wliusc life is il :uryaa)•?" 'I'Ite sccnnd fallalcy iuvul.rs ptll- linf, our failb iu n pnlilicizcd cotnnnmd-:md-cunlrul Incch:misnl Ibr cvalu:Uin:; Jrul,s aud plucc- dures. Wc Ir:lve sccu tltc ccnnuntic ;tnd ccnlnl;icad disasters lhal ccuu:d f;ovct'tuueul pl:ntninl; has prtMluccd in I•::Islcrn I:uroltc. What reason du wc have tu lltink Ili:d ccnU'aliicd plru•macculic:d :uid surl;ical pl:ur ninti tvill do:nty bcllcr licrt•; ('ausidcr Ihc nlmosphcrc iu wltich FDA opcratcx. If Ihc :IVcncy atakcx n tttim:(kc and :(ppruvcs n dl uI; Ihal ladcr tm u-i aall ln bc rot.:di•, it wt11I11csubiccl ol hu.Idccunl;lcs sinMt:d uvet.il;l(1 Itcat ulg.c:ntd cuunl- Irxr cnt(d i+ntal lx wx sloric%.'Iln' vic- nms ul Ibl. una:lkr will In• c:t.Jv illcnlificd, anJ Iltcir Ixt'snn:ll Iraf!- cdics will m:dtc couqtclling ncws copy.'I'his is uuc lypc ol' ntisl:dtc Iltal FDA will do its ulutusl tu avuiJ. Ou II(e uther h:lnd, ID(•rc is :nr alltcr type of ntistnkt• tlr.ll FDA cart also makc- Iltal ul' dis:qtprnvint, ur dekryin{t a uccdcd ncw drul, tutlil murc dala arc :rvail:lblc. 1'cuplc c:ul sttl)i'r aud the fi•onl Iltis snrl idc mis- lakc, as Ihc wom:ut in tinston uc:u•ly did, bul, tndikc in tlle first casc. these pcuhlc :o•c :Jntnsl ilttpossiblc In finJ. lVitlt rare cxccpli(rns, nci- Iltcr they nor Iltcir f:mtilics realized Ilt:d thc drugs ur dcvicr they nccJcd tvcrc Irnlllcd up :n I'I)A; :dl tltcy kucw was Iltat tkcir doclnrs cottld dn nulltinl; liu- Iltcut. '1'hcsc viclilus ol "lk'ut:-Iat;' :ntd "surt;icad dcvicc-1ctt;" arc invisiblc,:utJ lhcirstdfcrint; will tt•ighcr no conpressiunal hc:trings nr Ilctvti slol'iC:;. I•in• FI)A, lltc pulilic:d anll jotu'ncdislir.:onscqucncc:cal'dc- layinti a IrccdcJ drul; :n•c utinincd. As utucn as FDA may talk abotd Ilte need lu spccd lhc :Ipliruval pro- ccss, lltc instiltttional lin•ccs dc- scribed alwrvc inl, vilably result in (k•- IaycJ access 14) new lh n/!s :u1J prucclltu'cs. '1'his oulruml• wnn'I Irr cltanl,cd by t•clin•Ins 111.11 ooly tinkcr 441 I'1)A's tnart.ins. I(caJ rcli(rut in- vulvcs ch:roging Ihcsc filrccs by dclwliliciiiu{; lhc syslcm. 'fhc Coutpetitivc I•:utcrprisc tu- slitutc, a nt:lrkct-uricntcd poticy I;roup, has prulHutYl unc way to (lu this: cllcml;c FDA 1'ront :lu at;cncy that appruvcs dru/,s into atte Ih:d ccrtil-ics thclu.'I'lic sal•cly and clfcc- livcnctis uf ucw drugs wnuld con tinuc Iu be cvalu:ucd by thc at,cnry. Itatltcr lh:ut hcing hanucd, koax:vcr unappruvoJ dru{;s wnuld he nvail- ablc - by prescri;llion, on an in- fin'mcd consent basis witk clear w:u•nint; uf thcir un:tpprovcd slalus. In this way, lifc wuukl not chanltc liu• Ihosc d(n:lors and palicnl5 wiru Irust F1)A. Ilul for Ihosc who do unl. Ihrrc wuuld now lie :1 ucw, pnssibly lifc- savinl; opt ian. Siulil:u' rtdcs cotliJ lie tqtplicd Incvuh'inl; surl;ic:d dcvict•.. 'I'Itis :qtpr(iaclt w(luld milil;:dr FI)A's inltcrcnl 1cnJcncy Iow:u•d what CI•:I allarucy Sant I::n.m:ul ck:u-aclcrizcs as "dcadly (ovcrcan- SEC77Ui lion:' In Mr. Nazntan:s words rea.uut litr uur currcnt unh:tkl syslcut is lhis: "Wc havc all sccn lotiraplts of IhaiidolniJc viclinc we know notltinl; about Ihe vii of I'1)A:ti 11(-yc:u' dcl:ty ul' bcl:t li: ers or of its lwo-yc:m dclay au ditlc 11u-ontbolytics or :my ol ullier delays that FDA Itas silt wuscd:' Ity pulting Illcsc mcdic:d sions back in llic h:mds ol' th( licnls rlnJ tltcit- Itkysicians, wotdQn'l havc Io w(n•ry so it a1wu1 Iwlitics intrndiug ildn n cinc. We wouldn'I have to w alwnl 1he polilical prinrity nl' A therapies resulliui; in sltnvduwt such Jiscascs as kidncy cancct would Itc utorc cutl»/wcrcd as vi(luads lo t•ttn uto•owu livcs, aind, wtntW Irc nll lin' lltc bcllcr. I'cfe dn f'unf is u f(Irntcr Rcin emt f;overnor of bciuwurc. fiZ69969M