RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN 167 ment recommnendati<strong>on</strong>s for healthy post- Author Coetetbotf ... DrAnder<strong>on</strong>,. a menopausal -p<strong>on</strong>opal sity, Chieogn/E.nent<strong>on</strong>, women It: and with Robedt Wafoace, an Uni- intact iervesgotor of tre Worrrrn C<strong>on</strong>rdiating Health Initiatnve Center. hudsU Chinscal arenssto versty of the Iowa. datate. I-w the City/Daerrpsl Sian. toquEs Progarr R. Ilssom Of. Nati<strong>on</strong>a f-ear, uterus. Lung, and This trial did not address the stdyand tahesr-p<strong>on</strong>bdity <strong>on</strong> thteintegrity of fte short-termi Bl<strong>on</strong>d Instf~t.te risks and Clinical C~oodinasrg benefits of Center hor An- dots sod rte accurac of rthe data anlyses Study c<strong>on</strong>ept dt Z. LoC.<strong>on</strong>. and denigo, no<strong>on</strong> RosI<strong>on</strong>un E, Pattersn, Anders<strong>on</strong>, and Ros L. Prentice, fed H.isuctin m<strong>on</strong>es Cance givenfor Reserrh the Cente treasmentrofsneno- Prentan. Data and Safety Mu<strong>on</strong>tltorte Based: Janet Wittls pausal nymptoms. On she basis ofHlERS Acquislitio .I of data: Kooperbntg Anders<strong>on</strong> Preotire, Stnfasrrck, LaCrais, tack-n, tcftelr BeresO.d. Eugtene Howad. 8surood, cry Margaret Cohten. EUleahei Chenern Barrtt-C<strong>on</strong>nr, Hasand other sec<strong>on</strong>dary preventi<strong>on</strong> trials, Doid Detoets. Jolhmarn Kotchen, Ocleve. ten Darn. fohanna Dwyer, Robert P. Heantey, Victo the American Heart Associati<strong>on</strong> recoin- Analynis and inierpretatn ofdata mended RossuorcAndeaginst iniiating fisimen Vogei, L.eRoy Waiter, oe, Pr-nnor sod toter, IaCr-c4 YVusuf mendedagaint Ropebkeg,tStefanck,lJadns<strong>on</strong>. snitaltri postteno- Drafting or P<strong>on</strong>d1eglSatpprt the waecipt Rsoa.Anderse, The Bah<strong>on</strong>al Bl<strong>on</strong>d Heat.t lnstitstn Lung, funds the and WHI program. Wyethpausal horm<strong>on</strong>es for the sec<strong>on</strong>dary pre- Prenice t Ayrrt lR-notcs p-ouded tine study mednacn tavcntio cadiovasular ventin ofcrdiovscul, of disase."The dsease. The Critcal inlfertoa reviooo cntent: of the R.sso-, --a<strong>on</strong>yf for Andersor. inportant in- LaCrnis. tIne and ptocebhuf American Acbr-otdgrreti Hearts Associ.ati<strong>on</strong> The WIl Steele<strong>on</strong>g made Coireittee no t iKooyedsrtg. Stefani ck. alsn, aerenf<strong>on</strong>n, Homad, goate~fuckn<strong>on</strong>stedge the dednatd ryf<strong>on</strong> of firm the recommendati<strong>on</strong> for prsmary pre- Johns<strong>on</strong>, Koscien. Oske<strong>on</strong>. Staiissica WHI penyetise poticip<strong>on</strong>ti Andersn. and Prentice, of key WHI- Coopeincrstget-r staff and venis<strong>on</strong> while awaiting the at results the danicul from rnter berg aind the Clinical Coodinat- mg Center A fat Itoting of the W951 roresgaros ai randomized clinical trials such as WHII, Obtained funding, R<strong>on</strong>so<strong>on</strong>. Andersn, Prentic,, be fso<strong>on</strong>d at htrypc/cesw- hi.nrg and stated that c<strong>on</strong>tunuaui<strong>on</strong> of she treat- St1fanok, beresf<strong>on</strong>d, Ho.ard, Adnrantrac. Ktother. tcisnial, Ockern or watevel supptn R<strong>on</strong>- ___________________ mini should be c<strong>on</strong>sidered <strong>on</strong> the ba- snre And-ror, Pretice. L.Criora, loopenberg. REPO~aPCs sss of established n<strong>on</strong>cor<strong>on</strong>arv benefists Stefanick. iocksn, tiresford, Howad, lohns..n, 1. The corcten, W -nsensHealth Ockene. Initiaftiv Stedy Cr<strong>on</strong>y D.- and risks, possibhle cor<strong>on</strong>ary beneftss and Studs sopewmi<strong>on</strong> R-ossu, Ander<strong>on</strong>, loCroin sign of tine Wo-nen Healt Initt<strong>on</strong>n canica teial and risks, and patient preference. Stefa-icti, Jackso, Oeresfod, Howard, sohnso obeco1 nl tdr1otolCi Results ros9sat from XVrHI indicate that the Ktotcn "Orline. 1. O nf9 MCIl .E~e p-~ combbsned postmsneoopuLhomne .Stef<strong>on</strong>oc Ictrint. Stanf<strong>on</strong>d Center, for pausal hor fRech in th-rpyiandcnrnay nam<strong>on</strong>es et<strong>on</strong> hseatdoresn. Safod aq-athtuWn nnrit. a- e<strong>on</strong>o CEE, . 0.625 sensnent mg/d, of plus the MPA, rdenpid 2.5 olo mg/d, evidenc Di.- Pre P-en<strong>on</strong>StanfnlUniiwtC Sled eb 1 a. Gray9,91 een20 Pti47fet63oo<strong>on</strong> should not be inuiiated orc<strong>on</strong>tinued for i. AMen. Unioerstyofshtcnoin, foodisn: A-snifrs therain te preent di..os and profog life in p05 t the primary . prevenris<strong>on</strong> of CH D. In ad- B. Assf, B-na Urr<strong>on</strong>ityr. Providenc, RI: Tomn meoasa .oeren Ann tneter Med. 1992;1 17: disi<strong>on</strong>, the substanstial risks for cardio- Bi.My A LAhresyforAc owTcfiinsr Cowe ReSN itti7 vascular disease and breaost cancer must serh Center, Henry gOan. RosinPrebyterian-St fAc Rfpin A.t-. vn e SndrAn RfOf f be wesgbed agatinst she benefit for frac- Lokes hfndicol Unesi-dy Cente,. Choago,.I. of Nevda, Seem fitRbert Gregoy BrOn, L. r. Bathe. treray<strong>on</strong>seraniphtsandhyioprncerns Wake, untan. 1990;t2:2s9-2os. -Are - Ma4 sure sin selectisng from she available baret Itorcerty Schoof of Medicine, Winst<strong>on</strong>. 5. Adam MR. ogents Ktaplan so prevent Jo. Manisc St. osteoporosis. et al1 lohihi- Deere, NC, Mtle Caun, Kan-rP-intanefewisn s<strong>on</strong>fso-enoyarterythrruscle-osbys7-ketaer- W of Ilenhni. Oaklnd, Calif; Roma T. Chlebnnmst, trastlo in vanectomend m<strong>on</strong>keys: fork ot an effert Wrikeg Grap foe the Wnmos.W Reaso eassass.na. Harinu-UCLA Researh nod Educatin Institte, To- of added -etigutprogestr<strong>on</strong>. orn aqun Arter<strong>on</strong>cleris_ F.RuoM 1990.10. rB MD. N- roe ColA, Dard Curb, 0 Unmeor"a of Hama, Ho- 10s1-to57. It cf.W. nd ore,., Iliosncrra w ---,ttrys- w,.ia~~ Ga-ns iCin~u, L. Audrrs, PhD, Ca,- B. Bas 1. Prentie, PhD. Werss An-. NS. cinn Ore CL, . Ohio. .B fad Jennifer ifH. Wd4ant Hays. AB, Baylor Wahng Collge dm of JR Derneaud risk of fratoMs uf Z. LaCena., PhD, and Ch 'K-lopbekeg, tine PhD. hip and Medokire, lower Hout<strong>on</strong>. Tev, Gerrd Hel~s. Un-osty FIn~dnatdr<strong>on</strong>-Cac-ueeR of Iorroerovn pstnenop..asa sh Cenmer Seattle, -n Wash ofetg-nt Nnstir NFoci Caoia a 1fc ;s Susa Hendro, Mama Wayne L. stfnckk I Med. PhD l9oScasn31195-1198. St-nor Unoeroty Cncl State Snroerdy, School of Medklne/Htaef H<strong>on</strong>ystal CenoterStantntd. 7. Genat Cald, HKc. RreccaD Bylink lavso.unoMD Di. Gallagher )C, hro Ham Detroit. ST, Win,h Borbara V. Ho-cad, State MedStar Unootnty Re- Clinica Steig,,rfPHerbersn. Center. CoabS:htiid ffenr ofestnenesafate<strong>on</strong>np-rt- A. neahi lointid, W<strong>on</strong>hivof<strong>on</strong>, DC; ladi<strong>on</strong> Hssa, Georg e rropuosa h<strong>on</strong>e A. los. Be-eford, cusses Cynecol PhD, Fred HaclorN 1990:7k: Carm esarh Woshrgten Lln-fty, Wavyhrgtoo, Cevim, DC, F- Seaftil, dl~er Nb- Wash. Baiboar 579 t5B4. Hoadi. e bt Uwenityrof Star Reveurci Caliloria, Institate, loome ufntnDR Orange KooC. S. Steinihng inh<strong>on</strong>o, <strong>on</strong> arhker unr<strong>on</strong>styof taSSitinSi, Tennese, eta. Memphis; Amt-U Hnoard airhyn nthe effert ofestroen MDkso ,M. piacmnntrhrrapy MPH, U<strong>on</strong>esl ofToeseMo. add. U.Niersty of Catevorar, Los Aigde,;s sane 510- <strong>on</strong> Bhe rkobfn ph brass caer. JAMA. n591,2655r9B5. th lasefdodey fKatchenMOMD. duogutl. fy Xitrcnen, Medical Coflege -<strong>on</strong>o, Miknaake,l.dth of Wuc<strong>on</strong>~n, Mlifoo- OchrhDinut 1990. kt en; Le--n curler, tiN-vrityof Pittsburgh, M.ncactraei Pitts. 9. Gerhord<strong>on</strong>de Medical atos. VM, Lnndn orese S. BeprIdaciesarbargh, Pa, Oortfrj Lane, State Unicrsdyuof Financf5 NrscYok Dislosr.tor, DInaCnn. eugeno-a in femle oi-vestigafo hnorm<strong>on</strong>s and ot St<strong>on</strong>y cuinrecta Brok: tben D. Langt, UvNurty of Caii- cance by safote Cane <strong>on</strong>)2 Caunes ossnop-ces Cuntro 19923:3 .stahssparatly forded by Merk fre<strong>on</strong>, Sue Diego. Lasftia/Choia and Ptarr Vita; Dr tacm Norma L-nse, 359-3600 in an inesingutor <strong>on</strong> I ostn- Lrcorroy nf Medicine and ON~tisfr of New por-ss iersy. stdy funded It, HidIny by Mend S. Grady and D, 1 horm<strong>on</strong>e Basin T. et 01. Ra.nizevad stady N-madi Co.s tina E. Lends~, univrsty of Alabam at Bitun libidninmncen of estrgen PInsfandndtby progesin rntrr for & sernday GamtlrPlu.p-eentiur wnmgtiam Munran Liacher, Unroersty of Flordd. -aeuticak nf cnocray hrartdis.eosin postnenpaasIomv G<strong>on</strong>eAenuiytobsoes Foe ).A.n Camespod-e Ma<strong>on</strong>o,. Begkm lacquer end F. aAMA. R..-.am t99820,605 Macho, i-St13. Wames Hmprtal, Hror Medial Schoblof,Bos<strong>on</strong>. MD, 11. OiMo Godstem of F, W-mns~ Mans<strong>on</strong>i, Heal<strong>on</strong> Stample Irotiavie, orf. Pustineen- Nati<strong>on</strong>al Ma..: gore &argo. Uninrcrsdof Mnneuto. Hear. Mo- Lang, pos.frirnh and Binod Insttt.W r us and 0705 sec<strong>on</strong>day BRkfdedge pitevnb.o Dr. aiof -epnsis: ldith Ockene. univerity of Musach- nary One ecnnt Rockiedgo in the Nurse Ctr Heal<strong>on</strong> tote 300, Stady MSrl966, dun intern Bethsda setis Medal School, Woceste, MD May Jo 20017 O'SRivtmn, e -ma Med. rsou 2001.t35s-B. .ih~g<strong>on</strong>f Gamnes i. U.Ninoy ofcaioLMi. eami. Pla; Lor-ence Andero, Philips, PhD , DMssno 12, orAndeig&,P.NesvyLKHnflk.mpAS~e.rti.lin of Pablir ealthr Soenoeve Fred E.ma ry-ior ty, Agantm Ga; Cheryf Ritenbaugh. Hutchin-o Ka- Cancer cati<strong>on</strong> Reseach of horm<strong>on</strong>e Center, replacement f tODO Fii-aer therapy .er after Peoannte ouut Center nI. Health Ace- Reseowi N, MP-1002, Port- nyicndiW PO tnn 19020, infarcti<strong>on</strong> Seattle, is assossted WA mite land. woe Ors~uiiohnobmn. cadiac UnreNity of Cate<strong>on</strong>ia, Dau. evnts dutng foow Wino9 up. J2dm 10204e~o Coil Candlot goevetoroin 2001; orgl. Sacannto ORprlnt: Rober WHI Schehenk, Chrnrco University Coordinatung of Tecas Cent<strong>on</strong>., 3B Divc 1-7. Healtitorcr Centor, SandAniteaoyfciaWasnertrdnn<strong>on</strong> of Pablic '10. Heelth Heckbert Sv~en-e, S<strong>on</strong> Koplin Fred RC, Hosihinso W~ins NS, C<strong>on</strong> et - 01~ R~ik tote, of Albert cinstei Coadege of Medicidne. cer Blows, Researc recrrnt C<strong>on</strong>tnc, cornary f tO Pairiem -rol Ace in relui.t<strong>on</strong> N, teoc and r- MP- NYr: M-mrn rreUno, State Unruersy uf New rek 1002, cnt PO ivihoatino sac 19024. of pnstnenpa...aM Seattlr, WA 9B109-f hurrvne 020. therapy at Baiafl.; Linda Van H.n, BNotinwet-r Uneren. dmint It Med 2001,101:17W9 1173. us2 JAAw.ylal 7i, 2002-SVcl200.14.Sn3(fRyinote 02if02 Aoserics Medical Asnir itun. Asll righf csrevr ed_ DDw loa de d frm. u-s cm nat -- at Noti<strong>on</strong>al l steirr c HIh, A <strong>on</strong> Apri 1 6. 2007
168 RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN 14. Grodsten F. Mrts<strong>on</strong> JE, Colditz GAA Wi/St WC, 25. Grady D. Herrngt<strong>on</strong> D. Bitter V. et a, for the 34. SIhalter C. Luhbn J. Trla R. Sturge<strong>on</strong> S. 8rit<strong>on</strong>W Speneer FE. St.epfer MJ. A prnpectre. obserna- HERS Reesarnfh Group. Cardunaouolur diusW out- L. Homler R. Menopausal estrogen and entgenti<strong>on</strong> study of paeerpaosal hano-<strong>on</strong> thferopy rod c<strong>on</strong>e di6hrti8 yers of hnomniebrorpy- Heat and prosgti.repyetent tepy nd brertu uarcernuk. pim-ry preenter of rardbuasular disease AnnM. Ersroen/progestl Ropiacenent Study Ellow.up JAMA. 2/001023 485.491 ten Med. 2000:133:933-941. (HERS I1) JAMA. 2002.288:49-57. 35. Ross PK. PanhnHi HA, W. PC. Pke MC. Effect 15. The Wrntrg Group forI the PEP TrW Effects of 26. Sm<strong>on</strong> A. Hul. Caleyn A. et a. Po-tmeno- of hr-<strong>on</strong> pereplarenttherapyor breast cancer k: ho..<strong>on</strong>erpdacenrent therpy no erndmetra hiStoo- pausal hrn thepy e and i f stke th Heart enger<strong>on</strong>us estog ph. progeshe. J N&af Cnogy In poetneeopaasal woen: the Pnstrnnso ard EstrogAn -ptogSen Replaceent Study (HERS). rt itL 2000.92:328 332. po.usal Errogen/Pros0n. ntetseno tPEPillTteal. Ciratr 2001.103:638-642. 36. Coldit GA. Hnkis<strong>on</strong> SE, Hter D), et a. The JAMA. 1996;275370-375. 27. V-uor CM, B. LM Keern N, Sorrel PM So- urof etrgens and proge-tor and tre ikofrbrast 16. tNe DG. Fitrpnatk ALt BiMd DE. et at SurMit isea S. Hoenit. Rf. A linroul trial of astrngen. rcr-in postrrreoaamr.EnglJMed. 1995. ostertainmrotntotdinoodscoloresntr -nerefand the replcement therapy after irhenri stroke. N Engf J 332:1589-1593. Cardiosrsculur HealthStudy. An Fridnnco( 1995; Med. 2001345:1243-1249. 37. MgnourotC, Baro M C) ortEN, BergsbomR, 5:275-285. 28. Hodis HN. Mack WJ. Lob.RA, at. B.Estrogen in Admi H-0, Perur<strong>on</strong> .I1. Breant-cerinskfolfolndg 17. C<strong>on</strong> DR. RMgmo<strong>on</strong> Ort-alyss and life tables. J R the pr.eentl<strong>on</strong> of atherosclroois a randomired, l<strong>on</strong>g.-tenr rstrogen and nestrogen-progesttn Slat Stx 1972;34:187 220d d- blnd rorrbolted tetl. Ann tItem Med. 2001; repacement therapy. Itl Cancer 1999-81:339- 18. O rlen PC, Fleeing RT. A mldtple testng pro- 135S39-953. 344. cedre for dinita Mal btiometrice. 1979:35:549- 29. Arngem P. Stot S, Kothry W Smerft P. r<strong>on</strong> 38 Greendab GA. Rebheorin 8A, Sle A. et ad Effesr 556 Sdurky C. Effed of o.a pmobenn2pisat hormnne of estrogen and estroger-progetin <strong>on</strong> raror- 19. Feedmrn LS, Andersor G, Kipni V, t d. Ap- repLrent <strong>on</strong> progresut<strong>on</strong> of athnrosdoeis: a n. graphk pareechymot delity. AMtn totem Med. 1999: proacfeu to morito<strong>on</strong>g the reiults of org-term dt- domedzmnveedtrW AlnnnrosfermTh,- iV-SWo, 130:262-269. eaSa pre-ert<strong>on</strong> spat: no.Ptles hom the Womrens 207l1;21:262-26d. 39. Gmdtein F. Nnenmb PA, Stlmpfer Ml. Pot. Heaith lortwuen C<strong>on</strong>trol C/n Trils. 1996517:509- 30. Castefsgar ), Petre Gortham S. G-ri. Rod. moenopousil homrn e therapy and tie ik of coIn- 525. ngoa LA. Recent epidriologcd studes of the a- rectal -anuer are-le and me-anolysoi. A. lMed 20. Gail MH. Bnrto- LA. Byat DF. et at. Proeutng snttiohbetrcenn f<strong>on</strong><strong>on</strong>nreptcmenmttherapy nd 1999,106.574-582. Heruiduared probebilithesof deeloping bremtstcan reno s nthmoerbhofm a reroec.n Dg Sa.I 1998 40. hi1eS MR. MeadeTh. Wile SC. Hmnre rctor f hitn f-NakIs whore being eaaOned anna- 18:117-123. placemnt therappynda cedo-ascidardoearr. the caus ay Nal Cancer est 1989:91:1879-1886. 31. Grdy D, Weeer NK. Hemngt<strong>on</strong>D et0 a . Post- heorndorred ettoled ha. Cr Found Symp. 21. Pitue 0. Catlun AM. LerJ. IEstrogenre- reropustJ heot<strong>on</strong>e thertpy incasesrisk tare- 1995.191:150-160. ptac ent theriapy: defen<strong>on</strong>ants of persutroce roth roos tnrorboernolkrtd-eera the Heart tnd Esgenl 41. Torgeprn Dl, EI-Seyer SE. Homooe replacetreatment Ooset GYeNyO-. 200t197:97-100. pmgestrr RepaeetSt/udyyAnn In/ter Mee. 2000: ment therapy and pre-eobtn of n<strong>on</strong>nerteorna harc- 22. WrtgGroup for the PEP Toil Efects of etra- 132:689-696. rre-: a meto-anoysir of raodoroktd thils. lAMA. gen or retorpnlprogestin "m m-s <strong>on</strong> hetd di..e 32. Col.bativoeGr -p<strong>on</strong>Hmnrca Fartsirres it 2001.285:2891-2897. rrk futors<strong>on</strong>post-qinoaulm.s <strong>on</strong>rn lAMtA.1995. Cancer reat cancer and hormoe reptucement 42. Writg Group for the PEPI Tnil. Effects of 273 199-200. therapy:colhborat reanarlysIs of data fro 51 epa- h<strong>on</strong><strong>on</strong>e therapy <strong>on</strong> b<strong>on</strong>e mineral dueity: results 23. HeerklgtnDM. RebusooDM. r8rarhunKB.etM d ierobgiWoltradiecofS2.7J5 -er o thrbeea t/n- from the Posteenop.uoal Estrogen/Progestin at. Efects of esbogen replacement <strong>on</strong> the progres- ce rnd 10 .411 ro<strong>on</strong>ent with.ut b-rstrarort ta-n Inteesent<strong>on</strong>s (PEPI) Trul. )AMA. t99627S5l36dskn of remoury rteryathr-snlerois. N EnglMed. cet. 1997,3S0.1047-1OS9. 1396 2000:343:522-529. 33. Huelty S, Furberg C. BRaett-Coeno E. et a, for 43. Mnsca L. Cot/ms P, Henhgt<strong>on</strong> DM. et /a Ho- 24. Srhulan SP. Thieman DR. Oyang P. et al. EE- the HERS Rfeearrh Group. N<strong>on</strong>cardiooaruulr dis- mo<strong>on</strong> replacenst therapy and cidbousracuh disfectt of oa-te hro<strong>on</strong>e therapy <strong>on</strong> rcurrent isWhe- eas outA<strong>on</strong>es dunng 6.8 year of hnomroe therpy: - ase atent t hr heuhthcae prfesrorut lio the ula in poterenopuasal 0meo wdh -nst.We un- Hearsand Eroenlprobgestt RqaycmrtStudy oF- American Heart As.uti<strong>on</strong>. Crrruturin. 2001,104: gir I Am Coll Cardinl 2002.39:231-237. bw-up (HERS I1). JAWM. 2002;288:58-6. 499-503. 02002 Amiri-r etdi,,al Afrmsiote AU rights roseroed. tReorted) lAMA. July 17. 2002-Vol 2883 No. 3 333 Dotloaded fum cnrj~ba-.rom at Natl<strong>on</strong>at Iorituct of Hldh. <strong>on</strong> April 16,2007
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S. HRG. 110-129 Bioidentica
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CONTENTS Page Opening Statement of
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2 The sale of bioidentical hormone
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4 ever, as Dr. Wartofsky points out
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6 with every stage of the disease:
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8 I am pleased to appear before thi
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10 When the trials began, many rese
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Women who began treatment more than
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14 One small trial using oral estra
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16 FDA is aware that a growing numb
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18 DEPARTMENT OF HEALTH & HUMAN SER
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20 safety and efficacy. However, as
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22 adulteration and misbranding pro
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24 The 2002 CPG reflects FDA's curr
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26 Equally concerning are claims by
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28 concerned about the use and mark
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30 Part I: Materials and Partnershi
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32 drugs, when the compounding of t
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34 Our staff identified 34 Web site
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1. Introduction 36 Chairman Kohl, R
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diet and fitness products. 5 For ex
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include "natural" progesterone crea
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42 unique to the computer age, such
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computer users to spam(ftuce.0ov -
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46 accuracy of advertising for heal
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48 Now, you have identified in your
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50 claim." Therefore, since the ter
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52 Such quality control problems ha
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54 Statement Before the U.S. <stron
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in the U.S., whereas WHI participan
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58 between science and hearsay and
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60 How can we determine whether bio
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62 doctors-are not getting the obje
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64 27. Writing Group for the PEPI T
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66 Dr. MANSON. Well, I think that m
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68 Statement of Leonard Wartofsky,
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70 in the WHI. In fact, no study as
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In summary, the Endocrine Society i
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74 The FDA also regulates aspects o
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Statement of Loyd V. Allen, Jr., Ph
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Statement of Loyd V. Allen, Jr., Ph
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Statement of Loyd V. Allen, Jr., Ph
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82 Senator SMITH. Dr. Allen, as I h
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84 Now, when you are talking about
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86 The only thing the WHI proved wa
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88 Testimony Of T.S. Wiley before t
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Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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106 and the patient can be can reas
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108 Estradiol and Analytical Resear
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110 A controlled systematic pilot c
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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- Page 125 and 126: 122 These products that have been s
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- Page 129 and 130: 126 These are experiments by other
- Page 131 and 132: 128 cerebro-cellular inflammation c
- Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
- Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
- Page 137 and 138: 134 *Labor intense for patient and
- Page 139 and 140: 136 Senator SMITH. Thank you very m
- Page 141 and 142: 138 makes these hormones uniquely s
- Page 143 and 144: 140 tomize the Wiley Protocol by ra
- Page 145 and 146: 142 "natural," because all lead to
- Page 147 and 148: 144 maceutical commerce, often with
- Page 149 and 150: 146 WHITE PAPER #1 DID YOU KNOW THA
- Page 151 and 152: 148 WHITE PAPER #2 Pharmacy Compoun
- Page 153 and 154: 150 bleeding of the bowel, locate t
- Page 155 and 156: 152 compounding standards can be en
- Page 157 and 158: 154 I. The FDA's definition of a "N
- Page 159 and 160: 156 ORIIGINAL CONTrMIBTION JANMA-EX
- Page 161 and 162: Initially, the design allowed women
- Page 163 and 164: ards analyses," stratified by clini
- Page 165 and 166: year). These 'drop-in" rates were a
- Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
- Page 169: trogen plus progestin exposure. Clo
- Page 173 and 174: EFFECTS OF POSTMENOPAUSAL ESTIROGEN
- Page 175 and 176: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 177 and 178: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
- Page 181 and 182: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 183 and 184: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 185 and 186: 10000 isoor i I ea '° a wan 20-24
- Page 187 and 188: ~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
- Page 189 and 190: Is associated with an Increased ris
- Page 191 and 192: 188 Postmenopausal hormone therapy
- Page 193 and 194: group (P= 04001), and In this subgr
- Page 195 and 196: Treatmnent recommendations Based on
- Page 197 and 198: 21.Grodsteln F. Manson JE, Colditz
- Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
- Page 201 and 202: showed no striking differences in H
- Page 203 and 204: (214 cases; P for trend=.72): howev
- Page 205 and 206: 202 HORMONE THERAPY USE AND RISK OF
- Page 207 and 208: mal studies, and laboratory studies
- Page 209 and 210: 206 HORMONE THERAPY USE AND RISK OF
- Page 211 and 212: 208 HORMONE THERAPY USE AND RISK OF
- Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
- Page 215 and 216: 212 ,mucmai rimi &ronos farty bstro
- Page 217 and 218: 214 LntIucwu miau: rronos nary estr
- Page 219 and 220: XVI. PNharmacy Licensure Requiremen
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XVI. Pharmacy Licensure Requirement
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220 Roster of Board of Pharmacy Ece
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050. 0l7404405400 Al-h. PeVbU 03283
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Conclusions * Age is a powerful ris
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Women's Health Initiative Trials of
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Hormone Therapy after WHI * Change
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Statement of the American Pharmacis
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232 APhA Statement to the S
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234 APhA Statement to the S
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236 APhA Statement to the S
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238 APhA Statement to the S
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240 Written Testimony of Steven F.
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242 STATEMENT OF DAVID G. ADAMS On
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244 Report on State Laws and Regula
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246 Only one state, Utah, requires
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248 5. Compounding Copies of FDA-Ap