http://exhibits.library.stonybrook.edu/mfp/files/original/1b90fd0c31c4ad993fb2e548d39786f6.pdf 7353d39c2b965b74542b7c64168eb400 PDF Text Text T3SB~83583 20 December 1973 Richard Wittsnborn, Ph.D. Univorsity Professor Interdisciplinary Research Center Rutgers University New Brunswick, New Jersey 08903 Dear Dick: I am.utiting with regard to the ACNP~FDA Guideline Task Force Report dated October 1, 1973. I have not responded to that mailing earlier because I anticipated a meeting with the group in Palm Springs. As that meeting did not take place, I on taking this opportunity to respond with some comments. I three major sections carefully and, in of the Introduction, believe that this document may be used as part of the regulatory actions or the FDA. My com~ manta are based on this cvcntusl use. With this‘in mind, it seems to no that brevity is a virtue to be highly commanded; and negative ststemcnts, however,wcll intended. should be View have read the carefully cxpunipd. My principal criticism of the documsnt, therefbrc, is 1 and 2, the Introduction and General Principles, that Sections are much too lengthy, much too specific, and contain a number of pcjorativc ststcmcnts which may reflect the opinions of the writers but should be rcviewod carefully. I believe that those sections should be reduced to no more than a tow para» graphs of introduction. I note that many comments are made in the document which ordinarily would carry with them citations. I am struck that this lack of citations losses the reader with no recourse but to assume that the statcmcnts are opinion and not based on experimental tact. Nevertheless, there are many statements which are based on czpcrimcnts and I believe that citations should be provided. �Richard Wittcnborn,,Ph.D. —2~ 20 December 1973 Guideline Statements, Section 3, seem well written and clear. quite It is in these sections in particular that cite» tions ought to be requested. The Specific examples upon which these opinions are based follow. Introduction (Pp. 3-5) contains such pejorative state~ as, "The ‘gold rush' into the manufacture...," and "This possibility is already viewed with alarn'hy some drug houses' research d1rectora...." Page 7, Line 1, contains an error, I believe, that "June, 1950," should be "June, 1970." As an example of the specific nature of the Introduction which is undocumented, is the recommendation that certain rating scales be used, such as the IMPS, BPRS, and WPRS. Nowhere does it state the use to which these scales here already been put, and the reader is left with a catalogue without any clarification. Perhaps citations indicating those kinds of studies in which these scales hare been used successfully would be helpful. Indeed, a simple count of the number of studies each of these scales has been used in might be useful information. manta The Another example is the reference to psychomotor tests (Pp. 21-22), in which it is alleged that a "Hacker Cube drawing or a reversible staircase drawing has been seen to increase in response to effective anti-depressant medication." I do not think that this statement would be substantiated by the reference, for when we tried this test we failed to discrimi— nate imipramine from chlorpronasine. Perhaps someone else was more successful, and the citation should be given. In Section 3, "Antianxiety Agents," I found a number of gratuitous statements. For example, on Page 9 the paragraphs on indirect verbal measures, indirect clinical measures, phys~ iological measures, and behavioral measures each start with an assertion followed by an opinion. For example, "These measures provide estimates of affective states and other areas of function through content analysis of spoken or written verbal samples from the patient, by carefully trained technicians according to procedures specified in detail," is followed by "Although these procedures are less subject to some of the distortions encountered in direct measures, they are difficult and time consuming," The first sentence is useful; the second an opinion which, if true, should be documented. I believe the first sentence can stand in the record without the second. This is true for the other three paragraphs as well. I hesitate to suggest an addition, but it seems to me that the section on Phase III studies (Pp. lh-l?) might raise the question of the degrees of effettivencss of certain compounds �’73-- ,. .‘ _..-, -u .7 e... —w—'\:-m .3- Richard Wittenborn, Ph.D. 20 December l973 with continued use, i.e., "tolerance." I think this is an aspect of Phase III studies that in important for the pro— tection of the user. On Page 12, the "Criteria of drug effect" make no recom— statistical prOblems involved in such an evaluation. It is here, in particular, that the Committee can be very helpful in providing materials to the academic community and the FDA regarding statistical procedures and their pitfalls. Citations would be most helpful, particularly with regard to the problems of afipll samples, parametric and nonmandation regarding the parametric statictics, and.multivariate computer analyses. A note as to the meaning of levels of significance may or may not be added. Some of the comments with regard to the anti—anxiety sec- tion are equally applicable for the antiudepressant section, particularly the need for references and guidelines to statistics. In addition, the Opinions of the Committee are expressed on Pages 12-lh with admirable reatraint~~except Items 7 and 8. I hesitate to suggest that EEG measures provide evidence of efficacy and indices of change at least equivalent to verbal aample techniques. Indeed, in the studies which I carried out with Bob Khhn and Joseph Jarre more than 10 years ago, we found a greater sensitivity to EEG measures than linguistic measures. I have followed Lou Gottachalk'a data with interest but do not believe that the distinction implicit in Items 7 and 8 can be substan— tiated. ‘ Page 17 in Phase III studies, the Committee recommends a comparison of new anti~dapresaants with tricyclica, MAO inhibitors, and psychomotor stimulants. It might be useful to suggest that comparison of new treatments should be made with On the most effective anti~dspreeaant therapy available, that of repeated induced convulsions (BC? or ICT). I wish to command the members orally excellent set of guidelines. of the Committee for a gene_ Sincerely yours, Fink, an. Professor of Psychiatry Max MF/cis cc: Klerman, M.D. E. Uhlenhuth, M.D. G. � 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: Wiener, Murray Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-027-4-259 Date A point or period of time associated with an event in the lifecycle of the resource 1973 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. 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