http://exhibits.library.stonybrook.edu/mfp/files/original/52c9a0b11c7163a848f89c5a32a3edb7.pdf c8e1bb6f0f4d12bcae5e817b665a94cb PDF Text Text 7583—07383 13 February 1974 n E M O R A R D U H To: Stanley P. Yollco. M.D., for walton W. Shrcava, H.D.. Ph.D., Acting Aaaociata Chief of Staff for Raaoarch, VAH~Notthpott From: Max Fink. M.D., Profcaaor of Psychiatry Subject: Proposed Studios of Alcohol Dapondance at VAB-Northport were urged to develop studies in alcoholism at VAR—Notthport to oupplomant the ongoing rascarch weafforts 1n proposad the treatment of opiate dopendenon. In Soptanbor, a notion of studies to answer thrno questions: Last guano: we tolerance dovalop to long-acting bannediasopinoa? Docs Boas coloranca to a bonnodinaopino pto~ Vida "blockade" to alcohol (by cross- tolarance)? If such blockade occura, can it be put to clinical use tn tha maintenance of chronic alcohol~dapandant Iubjocta by high doses of a lags—acting bonnodiasopine? In this projact. wa proposed to no: a new bonzodiachinc, is particularly promising because wc hava obaarvou a duration of action that in conoidotably longar than other known bonaodiaaopinaa, nonaurcd by clinical observa— I have extions, KEG oxaninntiono, and blood level studies. Unitad States tonaiva axpartenca with this compound, both in tho OR!~8063. This compound and Turkay, whora cally acttvc. I havo found it -1- to ba Info to use and clini- �YolleslShreeve 13 February 1975 -2~ Since submitting this proposal, on have been asked many questions by the Research Committee. Most questions are focussed on the legality of our use of ORF~8063, and only occasionally have questions been asked regarding the design or safety of the experiment. I believe we have answered the design and safety questions satisfactorily. In Decenber the Committee requested that we give than an nunber; 1 indicated that this would be a study under the IND of the Ortho Research Foundation. When they insisted on written evidence, I requested a copy of the IND letter, and the monitor sent us a letter they had on file. The letter, dated April 8, 1971. referred to studies than approved and indicated single doses were then under study. IND Since that time, the Ortho Research Foundation has submitted protocols to the FDA for repeated administration of the drug in can. These studies have not only been undertaken but have been published, and include two reports submitted to the Committee: "On the Anticsxisty Properties of'a New Benso~ gygg;.Thsr..Rss., 15: 288 (19?3). In this study, Sskalis and his co~workers have given 0R3a8063 for 21 days from diasepins, oar—8063." 30~150 as a day. - "08F;8083, an Early fluctuation of'a Haw Anti— anxisty Agent.” Curr. Ther. Rust, 14:664 (1973). In this study, Gallant and his nodworkers re— ported the treatment of 8 chronic alcoholic inpatients for an average of to 160 as daily. 25 days, from 10 mg In addition to these two published studies, I have submitted capies of reports of my own work; and indicated that I an personally aware of 20 additional neurotic patients treated for 6 weeks in doses up to 90 mg per day. in a study which I am aonitoriug in Istanbul. I also attended a conference (June, 1973) at which 7 investigators (including Sakalis and Gallant) presented data on varying dosage schedules in man for extended periods. in requiring a letter from the FDA justi~ tying this study. is asking for a procedure which the FDA does not ordinarily follow. In this request. I believe the Committee is exceeding its charge. Should the Committee persist in this denand-that we obtain prior approval for a study from the FDAr— the centers would abrogata their responsibility to decide whether a study should or should not be dons at the VAHrHorthport on the data presented. Continued insistence on IND approval as a pre~ requisite for studies will not facilitate research at VAR-“orthport and will not establish that hospital as a center for human The Committee. studies. �YollcsZShtnnvc ~2~ 13 Pabrunty 1975 w-mw "'Wrwwwr» I halicvu that the Connittcc salad «finitely in its original ruquast for 130 duct; tad that I aattd unwingly 1n attunptins to lag: thslr dcuand. I hulicvn I! havo submittod sufficient in— foranttan to warrant the judgnoat that the study should be approvud. ¢nd nah your udv1¢o is to the aux: stop for us. M3/cil 3-th � 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. Note that facsimiles or images of texts are still of the genre Text. 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 to: Guy, William Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-027-5-367 Date A point or period of time associated with an event in the lifecycle of the resource 1974 Creator An entity primarily responsible for making the resource <a title="Fink, Max, 1923-" href="http://id.loc.gov/authorities/names/n79039548" target="_blank">Fink, Max, 1923-</a> Subject The topic of the resource Correspondence -- Correspondence Relation A related resource The Max Fink Collection Description An account of the resource Rights Information about rights held in and over the resource <a title="IN COPYRIGHT - EDUCATIONAL USE PERMITTED" href="http://rightsstatements.org/vocab/InC-EDU/1.0/" target="_blank">IN COPYRIGHT - EDUCATIONAL USE PERMITTED</a> Source A related resource from which the described resource is derived Special Collections and University Archives, University Libraries. Stony Brook University Libraries (State University of New York). Language A language of the resource en-US Format The file format, physical medium, or dimensions of the resource application/pdf Publisher An entity responsible for making the resource available Contributor An entity responsible for making contributions to the resource Correspondence