http://exhibits.library.stonybrook.edu/mfp/files/original/78f9d773f1b6d7c000b897bf36b09f59.pdf 65905657956453fe40e070a9a92c336d PDF Text Text ‘ ,. \\ g ‘ YR ,. ,vvmrgpu September 14, 1970 Dr. Norman Pitts Chas. Pfizer G Co. Groton, Connecticut 06340 Dear Norm, I have read with interest the proposed guidelines for evaluating novel anti-anxiety compounds (received 9/8/70). Such an outline reflects prevailing practice, but makes no effort to either justify the practice as acceptable nor to highlight the hazards of our present practices. As on a statement of present procedures, special studies is interesting evaluating methods now it is acceptable. The section and provides clues as to novel under study. Some specific comments are found on pages 3 and 4. In the introduction, the marked paragraph may be omitted as gratuitous; and on page 4, the section should be omitted since the NIMH—ACNP report is and should not a discussion of problems and issues, not guidelines be so dignified, especially since the documents are not completed. Would it not be premature for the PMA Committee to incorporate an unpublished report before it is issued? — The initial single and multiple dose studies should be done in paid volunteers, to assess safety and not in pagients (page 6). qualities that is a statement that would describe the steps a potentially effective trials, The animal pharmacology which is used; the (chemical and pharmacologic) of known anti«anxiety agents What I miss most leading to clinical therapeutic agent. seem common and criteria for to this therapeutic group; and especially, those For example, all accepted anti-anxiety drugs are anti—convulsant, sedative (hypnotic), produce seizures on rapid withdrawal and tolerance. But other drugs have anti—anxiety qualities as various “anti-psychotic” drugs, some anti—depressants, calcium salts and such,additional substances as ethyl alcohol, opiates 33g, aspects of present drugs that need improvement. - �Dr. Norman Pitts ~.2— September 14, 1970 In making these suggestions, I am reacting to the limited goal of these notes - i.e., minimum guidelines for clinical assay; as perhaps too limit33~?or industry. By broadening the document to include animal pharmacology, criteria for early identification, and suggesting that the drugs are symptomatic (therefore, not easily categorized), PMA may highlight the complexity of the issues and minimize the utility of 1970 issued, rigid ”guidelines”. I am also concerned with the lack of supporting citations for of the introductory statements. A detailed, academic presenta— tion would be a more powerful statement. many Thank you for the opportunity to read this document. Sincerely yours, Fink, H.D. Professor of Psychiatry Max MF:kt � 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: Pitts, Norman Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-024-8-413 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