http://exhibits.library.stonybrook.edu/mfp/files/original/a190f04974d61f9aa85cc12b119d7f22.pdf 38aa534f3f43c984901da0ee914c2596 PDF Text Text .‘ Y'fies-«v'w Irraw- February 12, 1970 Dr. Edward Woodward, A. H. Robins Company 1407 Cummings Drive Ridhmond, Virginia Jr. 23220 Dear Dr. Woodward: fcnfluramine-behavior study (#0761) was undertaken following our observation that the EEC profile was more like amobarbital than dextro-amphetanine. Since we had no prior experience with studies of weight reduction and anorexia, we proposed a study to observe the behavioral effects of fenfluramino and placebo. Since this was not feasible without a protocol, one The was filed. double-blind, with neither the subjects nor the observer aware of the medication given. Tfie study was In tho during the subjects, sedation and somnolence occurred first few 2—4 days of drug trial, and did not with placebo, initial which by the 1.8., reports of the subject we were able medication they received. We confirmed this breaking the first 7 codes. after to discern 7 subjects by An analyses of the behavioral data indicated that sedation At this point, was indeed the most prominent symptom. we cases. found only one Since we were continued the study and with succeeding reporting stimulation. ill-equipped to questions of weight reduction, difficult group of subjects. we answer the many relevant had prohloms in managing this In a telephone discussion, I indicated that I was satisfied with the behavioral data, remarked on the difficulty with the weight reduction aspects, and recommended the study be discontinued. �//- Dr. Woodward With February 12, 1970 ~2— this badkground, the following are Specific answers to the questions: 1. Study was double-blind. Crossover resulted from a desire to assess the differences, if any, in behavior. Also, since the subjects signed a permit that included "placebo“, at the end of the study they inquired whether they had received "drug” or “placebo”. For the pationts who received placebo, a trial of active drug was 2. offered. 3. 4. I \soo notes this letter. Suppliofig see attached. FDA: trust this is reogonsivo and usefbl. it Siggoroly yours, '5.“ Fink, H.D. Professor of Psychiatry Max ‘ Mszp /‘\\ //A7[\Jx7 � 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: Woodward Jr., Edward Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-024-2-057 Date A point or period of time associated with an event in the lifecycle of the resource 1970 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