http://exhibits.library.stonybrook.edu/mfp/files/original/b4e0efe5846a1ebe06a44347d3339622.pdf 02bda3309d4d7e7cab3b248f62f77b87 PDF Text Text w .—,....,.A .. December 17, 1968 Honorable Norman P. Lent Chm., Joint Committee on Health State Capitol Albany, How York Dear Senator Lent, I am writing to roquest sarious consideration to the potential hassrds in tho proposed amendmont to the public health law in relation to human research (8. 4015A, A.5586A). I have read the proposed amendments and find them too restrictive in their text with regard to the continuation of research; definitions of 'roscsrch'. and too vague in the Since 1952 I havo been engaged in rosesrch in montal illnesses. with specific sophssis on treatmouts using biological methods. First at Hillside Hospital in New York (1952~1962),thcn as tho director of tho Miaaoori Institute of Psychiatry (1962~l966) and at the New York Medical Collage whore I am Director of the Division of Psychopharmacology and Drug Addiction. I have found that none of the techniques which are needed in the study of man van be carried out in animals. neural illnesses soon peculiarly human frailtieo, and their study, while raconmonded it animals by others, are totally unsuccessful. Progress in treating the mentally ill seems to cons only from studies in patients, as with convulaivo therapy, the many now drugs, and recently, in the treatment of opiate addiction. now At present, our emphaais is in the biological troatment of opiate addicts. The peculiar nature of the illness, and the methods which are now useful ( methadone maintenance, cyclsrocine and nsloxone antagonism) have been developed in patient studios. The proposed law suggests that all studies will have to be cleared by a committee, half of whom will be laymen. Considering the difficulties with methadone maintenanco with Federal authorities, and initially with state authorities, I am sure that such a committee will prevent any research which at the timo may be considered hazardous, thereby preventing progress. Lot mo cite a specific example. In our studies of mothadouo inttho traatment of addicts, we have measured the affects of methadone on brain function and find that the changss ara so like some that we have found useful in the treatment of severe schizophrenic patients, that we proposod a study of methadone in the therapy resistant psychotic �Senator Lent December 17, 1968 2 pationta at our institution. The proposal was carefully reviewed by our College committees and approved. 0n referral to the Commissioner of hospitals. howovor, the proposal was dioapproved since mothodone is considered an dddicting drug. It is strongo that laymen are for when all hopo has been willing to allow the severe montally nbandoned after all other mthodc have been tried, to forgo a potential ill, therapeutic benefit, out of fear. All research must be daring to be oudcasaful. All human research can ho monitored by our poets, and the present committees have shown themselves to be useful. Since their introduction during tho post foo years at the urging of the Federal granting agencies, it aaams premature to antablioh another mechanism bofore this one is ‘fully established. Specific objectiona to the logialntion are as follows. will consint of laymen in the majority. Modern too complcn to be rovicwed by tho laity except when one tachuiqcos are hoscl no oxpocts responses prejudice and emotion. Research cannot be omotion and be judgod by roaaon«~ whcrovor poooiblel should by judged The Comoiosion will oit far away from the site of tho rosoarch. It goons that there will ho only one full time mentor, and it is inconceivablo tact tho alto of the roooarch. tho qualifications of the investigator, and the Quality of the protective devices can The Commission be monitored omcoyt in tho locale ohcro the study is done. If a committee of visitors is established, than the device will be overly cunbersono and oxponoivo. conflict hatwocn reoearohy at poorly dofinod, and medical treatmont as practice, is not rcoolvod by the logiolntion. If I treat a patient with a new treatment will this ho exempt if I on paid for it as part of medical practice; but not exempt if done for no fee as part of a research program ? The The problom of consent has been adequately discuoood Fodoral in the legislation of a tow years ago. Thorn are special problems in dealing with the mentally ill, and the propooed atote legislation does not dofino the safeguards which experience has shown to be useful and necessary. There are othor problems which are not clarified in the bill. It is regrettod that tho legiolnture finds it necessary to propose state legislation io.an «tons where existing legislation. if adequately administered. would be most odoq’nto to protect our fellow citizans and ourselves. American research has been in the forefront in all fieldo except in the care of the mentally 111. Most of the modern advances in their treatment have coma from Europe. In part this resulted from our ovcrinvoatmont in psychotherapy; and in port. from the restrictions placed on research in our institutions for the acuto mentally ill. The addition of this burden, on oxemplified in tho proposed lcgiolation, will handicap Amorican research even further- for such legislation is unlikely to remain restricted to our stotc. since we have been a bollwoathor state. �Senator Lent December 17, 1968 3 In writing this letter, I on acting on my own behalf as Director of the Division of Psychophnruaoology and Drug Addiction of the Department of Psychiatry; and as tho Exocutivo Diroctor of the International Association for Psychiatric Research. Inc. The IAPR was established in 1967 to provide a nochonisn whereby collaborative research could be undertaken in othor localities where the restrictions were less stringent. Because of limitations in committee actions at the Federal level, we have undertaken some important research in trottnont of mentally in Istanbul, thoroby confirming studies We hnvc also begun a study of from France. originally reported marijuana in Greece since the restrictions imposed on the study and sunply of this impotttnt agent in the United States have been so great that wn havo had to go through multiple oomnittons and 18 months delay before undertaking ouch studios in New York. ill Your consideration of these comments is appreciated. legislation will, in our opinion, do more harm to our citizens not ouroolvos than any potential good that may be imagined. Your oomnittee's disapproval is roquooted. Tho proposed Sinceroly yours, Fink, PhD. Profossor of Psychiatry Max � 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: Lent, Norman F. Type The nature or genre of the resource Text Identifier An unambiguous reference to the resource within a given context mfp-05-00-022-6-558 Date A point or period of time associated with an event in the lifecycle of the resource 1968 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