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Il T*y countries, government officialsand doctors rely almost exclusivelv onpharmaceutical companies or their ,.Oetaitmen ' tor rnlbrmation on a drug's safety.The 1983 internal memo of Upjofrn;, [J.i_duced here is an unusuut'llirnpr"-intcorporate strategy in getting across desiredlfformatlon. In Upjohn's cover memo.rererence is made to Stephen Minkin,fgrT"t nutrition director wiih the ilG;Nations in Bangladesh, who fras *.iiien:everal articles exposing problems withuepo-ltovera and deficiencies in safetytesting of the drug._ Note our rebuttals to Upjohn's ..KeyResponse Statements. "

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l . ond 4. In mony countr ies, orug" reg is t ro t ion" i imp ly invo lve iregistering the drug with customs.Even. "opprovo l " by o fo re ignheo l lh min is te r i s o f ten bosedonly on informotion supplied bythe drug conrpony i tself . The Swe-d ish governmenl , recoon iz ingDepo-?rouero's dongers Jnless i ti s odmrn is te red w i th c lose mon i -toring, prohibits i ts internoi ionoldevelopment ogency from pro-moting the drug obrood.

2. The FDA Boord of Inquiry rec-ommended los t Ocfober tho topprovol of controceptive use ofDepo-Provero conf inue to beden ied . In 1978 the FDA i tse l fgove four reosons for i ls deniol ofopprovo l ; fh ree o f them werescienti f ic, ond o fourth wos thoino signif icont potienf populot ionneeding the drug hod been dem-onsiroled.

3 . The FDA Boord o f Inqur ryfound thot there is no proof thotDepo-Provero does no l couseconcer. Concer did result rn re-quired fests of the drug conductedon beogle dogs onO monkeys;Depo-Provero wos the only con-troceptive thot coused concer Inboth 6f these mommol fests.

5. There frcve been no studiesc o n d u c t e d o f t h e s e c h i l d r e nthrough puberty, when reproduc-t i ve obnormol i t ies wou ld mos ll ikely become evident. One studyof infonls exposed to Deoo-Pro-vero lhrough breost milk showedlhot Depo-exposed rnfonts weremore vulneroble lo common rn-fec t ions lhon o ther ch i ld ren . Anumber o f s fudres showino nodifference in Depo-exposeJondother chi ldren were reviewed bythe FDA Boord o f Inqu i ry ondfound lo be inodeouote.

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5. The FDA Boord o f Inqu i rycri t icized the scienti f ic studies o?Depo-Provero os be ing , ,hop-hozord" ond "uncoordir ioied.,, '

7. Judith Weisz, choir of the FDABoord of Inquiry, hos soid of theOB-GYN odvisory commiftee,srecommendotion of opprovol ofDepo-Provero, "Theirs wos of ree-whee l ing d iscuss ion , no tsenous onolysis. l t 's o shome lholi l wosn'1, since they now gel ci tedos ihe outhorit ies." One of theodvisory commitlee's own mem-bers commenled thot the moreyou know obout physiology, theless you wont lo toke lhis drug.8. As the FDA Boord of Inquirystoled, "The lock of odequotelong-term fol low-up of subjectsconnot be obscured or overcomeby pooling of doto from womenw h o h o v e u s e d t h e d r u o f o rd i f fe ren t per iods o f t ime"ondpresenting lhese dolo in forms of' w o m e n y e o r s ' o r m o n t h s o fuse. . . . While i t tokes nine monthsto produce o boby, nine women,eoch one conir ibui ing one monlh,connot produce o boby."

9. This is on especiol ly imporlontoreo where there hosn ' i beenlfgeuote study with long rermTOl low uD_

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10. l t 's been o mo jor concern o{women's groups ond experts l ikethe Medicol Committee in Englondthot lhe lorgefied populot io*n forthrs drug, oiten uneducofed orunderpr iv i leged women, hovethe leost obi l i ty to qive informedconsent. Grif f Ross, lhe membero f t h e F D A B o o r d o f I n q u i r vrecommended to the ponel byUpiohn, recommended ihot thedrug be opproved for use in fheU.S. 9y d rug obusers ond themenlol ly retorded. two of the verygroups un l i ke ly lo be ob le to g ivesuch consent. One of the moiorc r i t i c isms in the

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the Grody study in Atlonto wostho t ne i ther s lo f f nor po l ien lsseemed to be owore of the druo,sexperimeniol siotus.

l l . ond 12. Governmenis oroundthe world ore concerned when odrug is notopproved for use in i tscount ry o i o r rg in . Even. thoughlJepo-rrovero rs curreni ly regis_tered or opproved in 80 counirres,tnose dec ts tons ore no t i r rever_sible. Continued FDA deniol ofopprovol wi l l fuel opposit ion toi h e d r u g , o n d u n d e i m i n e U p -l o h n s r e p u i o t i o n o r o u n d t h eworld. ,r

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