http://exhibits.library.stonybrook.edu/mfp/files/original/d8218b2074104e64952b7bf69df8d312.pdf fe99418477f5910e062d8a73238aea2a PDF Text Text _ : ~ wwwwxw «n-r- A4 nuw n—ww Haw: -v w 1’f'I-W-'F‘I‘Tw_fl” smug-«an. :. ~, 5‘. , -w "l ”.1. ,-. :..—.;.:v—c-.~.~ vs..-“ A”. u ,.., ,h.,.,w.r_c.,,.,,,,.,.. 1. 7.7M .4- n.” “H“, _,__ .V Aprll 23, l970 _ A l I, - A ,..l-.v — —-. Dr. Ralph Jacobson Endo IQOO Laboratorlss Sfowarf Garden Clly, New York ll530 mfi‘a-n- ‘_-.,mm—.-,;_.Wv /v“\ ‘C'IQ‘W:'-twrw"“-\vri Door Ralph, Some months ago, we dlscussod the posslblllly of a broad cllnlcal lrlal of oral naloxono ln slnqle large dally doses (2.4 lo 3.0 Gms) ln oplafs dependenf subjects. You wlll recall That no roporfed our obsorvallon lhal dolly doses of l.2 and 2.0 falled To profecl our subjects beyond l8 hours lo 25 mg lnfravonous heroln, bu? the? 2.4 and 3.0 Gms wore sffscflvo for Gms more Than 24 hours. Upon your reassurance Thal Mr. Bovld Kloln, your vlcs~ prosldonl, had personally rooussfsd fhs suppllos be made avollable, we rolurnod our romslnlng naloxone, so Thaf The larger lablols could be prepared. Durlng The pas? 6 months us have received monfhly roassurances That naloxono would shorfly be avallablo. ln your message lasl week, you slated fhal prlor calls on your suppllos. plus dlfflculflos a? Molllncrodf Chomlcsl, plus expense and olher»oommllfmsn+s a? Endo, made if unllkoly lhaf naloxono would be avsllablo for cllnlcal lrlals before Soplember of The oarllosl, and roallsflcally, probably no? unlll +he end of rho yssr. Mosnwhllo, lho publlc press lndlcalss (from your release?) an NBA for Narcan ls lmmlnonf ”wllh cllnlcal ovaluollon expoclod To be complsled wlfhln 6 lo 8 monfhs on Tho drug's efflcacy ln horoln and oplofo dopondonoo.“ Tns roporf makes erroneous references lo the work In fhls laborafory, and oven allowlng for roporfsrlal errors, l am concerned +ha+ l may be mlsquofsd - not only #0 The press, but To rogulafory agonclos as woll. lhaf Our flndlngs wlfh oral naloxono ln 7 cases have been publlshed. flndlngs wllh dosages to 3.0 Grams/day are confldenllal and were reported lo you To supporf our collaboraflon, and were not Our subsoquenf avallable for FDA submlsslon or publlc reporllng. V . , , ‘ ,fl V _ , �Fwwww om r ”aw-H Dr. Jacobson -2- April 23, l970 » A-vr V.-—..n—P—..—«>—- i hope The misquoTaTion did noT resulT from an Endo reloasa, buT did come from an enThusiasTic roporTer's misquoToTion of our preliminary reporTs To The STaTo NarcoTlc AddlcTion ConTroi Commission. ‘i am wrlTing Today for The following reasons: i. To record my undorsTandlng of your Telephone call oral naloxone ls noT available for clinical Trial in opiaTe dopendonco in daily doses of 2.4 To 3.0 Grams; and ThaT The earliesT daTo for such supplies may be SopTombor i970. ThaT us during 2. To requesT ThaT The supplies of naioxono, roTurnod by The winTor, be made available To us once again. As you recall, we have boon able To adminisTer cyciazocino very rapidly, proTochnq our subjecTs againsT The agonisTic offocTs of cyclazocine by oral nnloxono. We have found ThoT 300 mg naloxone, 3 To 4 Times a day for 3~5 days, is useful in cyciazocine lnducTion. We wish To TosT This observaTion in 50 consecufivo addlcTs, and require 4.0 Gms/ subjocT or 200 Ems. our presenT supplies are almosT exhausTod. we would like To carry ouT This sTudy as rapidly as posslbie. Can you reTurn 209 Gms naloxono in 303 mg (or lOO mo) TablaTs To us wlThln a monTh? 3. To suggosT ThaT we adhoro To our undersTandlng, ThaT oTaTemenTs regarding our work, be made by prior iniTial consonT You will recall ThaT our College has subscribed To such an undersTondlng. The enclosed reporT may roilecT a TransienT lapse of ThoT undersTanding, and i TrusT does noT soT a procedonT nor docs lT represonT a change in our undersTondlno. 0r doos lT? public only. Ha. ww-m‘rv— layover» <- w" we“ u» man-e: r-c .w;7~.w- incidonTolly, Tho reporT of progress in a long acTing naloxone prooaraTlon was encouraging. You will recall, however, ThaT The figures you ouoTed, regarding The amounTs of naloxone To onTagonlzo heroin in our subJeCTs, seamed ouT of Thenecessary range of our experience. i suggosT ThoT Those figures require revlow, parTlcularly if The pharmacouTlcai chemisTs oro using Them as bonchmarks in Their work. will call your office in lo days, if i have noT heard sooner, regarding your release of 200 Grams naloxono for a cyclazoclne-naloxone i sTudy. Sincerely yours, yruvap',"-‘WL Max Fink, M.D. Professor of PsychlaTry MF:kp GUC. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Correspondence Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. 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