- Email: [email protected]
The drug evaluation activities of the college
89
News/ Drug and Alcohol Dependence 38 (1995) 87-90
tion, P.O. Box 2345, Rockville, MD 20852 USA (8007296686). Citations for the two most recent proceedings are provided below: Problems of Drug Dependence 1992,L. Harris (Ed). NlDA Research Monograph Series 132, NIH Publication No. 93-3505, 1993. Problems of Drug Dependence 1993,L. Harris (Ed). NIDA Research Monograph Series 140 and 141 (two volumes), NIH Publication Nos. 94-3148and 94-3749, 1994.
The 2-volume Proceedings of the June, 1994 meeting will be published as NIDA Research Monographs in early 1995. The nature of the Proceedings have changed over time. In early years, full reports of scientific presentations were included, but now that the meetings contain over 600 volunteered papers as well as many symposia, this is no longer feasible. Currently, the Proceedings contain I-page reports of the volunteered presentations. Summariesof the plenary lectures and symposia are also included. One feature of the Proceedingswhich has not changed significantly for many years is the publication of ‘reports’ of the CPDD Drug Evaluation Program. This program, which has been a core component of the College’s efforts for 50 years, was described recently in the CPDD News and Views (Drug and Alcohol Dependence, Volume 34:259-263, 1994). These reports contain what, in many cases,is the sole published report of the results of testing drugs for dependenceliability. The complete set of these reports comprises an enormously valuable scientific resource, particularly in the area of opiate pharmacology. Sponsorship of the Publication of Reviews and Position Papers From time to time the CPDD Board of Directors undertakes to commission special scientific meetings, review papers and position papers on topic of current interest. The CPDD Publications Committee has the responsibility for oversight of the publications which appear under the CPDD’s imprimatur. A list of recent publications sponsored by the College is provided below: Eddy, N.B. (1973)The National ResearchCouncil Involvement in the Opiate Problem, 1928-1971, National Academy of Sciences, Washington, DC. Schuster, C.R. and Harris, L.S. (eds.) (1985) Mixed AgonistAntagonist Analgesics. Special issue of Drug and Alcohol Dependence, 14(3,4). Scientific perspectives on cocaine abuse. (1987) Report on a joint American Society for Pharmacology and Experimental Therapeutics (ASPET)/College on Problems of Drug Dependence (CPDD) conference. The Pharmacologist 29, 20-27. May, E.E.L. and Jacobson, A.L. (1989) The Committee on Problems of Drug Dependence: A legacy of the National Academy of
Sciences.A historical account. Drug and Alcohol Dependence23, 183-218. Fischman, M.W. and Mello, N.K. (eds.) (1989) Testing Drugs for Abuse Liability in Humans. NIDA Research Monograph Series 92, DHHS Publication No. (ADM) 89-1613. Fischman, M.W. and Mello, N.K. (1991) Introduction. CPDD sponsored reviews on methods for testing the abuse liability of stimulant, opioid mixed agonist-antagonist, and anxiolytic and sedative hypnotic drugs in humans. Drug and Alcohol Dependence28, l-2. Foltin, R.W. and Fischman, M.W. (1991) Assessmentof abuse liability of stimulant drugs in humans: A methodological survey. Drug and Alcohol Dependence 28, 3-48. Preston, K.L. and Jasinski, D.R. (1991)Abuse liability studies of opioid agonist-antagonistsin humans. Drug and Alcohol Dependence 28, 49-82. de Wit, H. and Grifliths, R.R. (1991)Testing the abuseliability of anxiolytic and hypnotic drugs in humans. Drug and Alcohol Dependence 28, 83-l 11. Balster, R.L. (1991)Sponsorship of the journal Drug and Alcohol Dependenceby the College on Problems of Drug Dependence. Drug and Alcohol Dependence 29, v-vii. Anabolic steroids: Current and future perspectives on their use and abuse. (1993) Report on joint ASPET/CPDD conference held on June 7, 1991.The Pharmacologist 35, 86-88. College on Problems of Drug Dependence. (1995) Human subject issuesin drug abuse research. Drug and Alcohol Dependence, 37, 167-175. Prepared by Robert L. Baker, Ph.D., Chair CPDD Publications Committee SSDI 0376-8716(95)01123-G
THE DRUG EVALUATION ACTIVITIES OF THE COLLEGE The College on Problems of Drug Dependence (CPDD) has been in existence since 1929 and is the longest standing group in the country concerned with issuesrelated to drug dependenceand abuse. The CPDD has a number of important functions, including organizing the premier annual scientific meeting relating to substance abuse and providing input into public health issuesand policies related to drug abuse and education. One of its more important activities over the past 65 years has been in testing drugs for their abuse liability. Under its current organisation, the CPDD’s dependence liability drug program is overseen by the Drug Evaluation Committee (DEC). The historically pivotal role that the CPDD has played in dependenceliability testing is underscored by the fact that from the 1930suntil the early 197Os,the CPDD was an integral part of the U.S. government regulatory process responsible for assessingthe abuse potential of new drugs prior to any control decision. Although there is no longer a federally mandated requirement that CPDD test compounds with suspected
90
News/Drug
and Alcohol Dependence 38 (1995) 87-90
abusepotential, the Controlled SubstancesAct requires the Secretary of Health and Human Servicesto obtain all relevant scientific data concerning the abuse potential of new drugs prior to a control (scheduling) decision. In practical terms, the Secretary relies upon the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), and to a lesserextent the Drug Enforcement Administration (DEA) for the provision of thesedata. These agenciesutilize CPDD as a major source of testing information: NIDA, DEA and the FDA routinely request ‘position papers’ regarding the dependenceliability of drugs. Both NIDA and DEA regularly submit compounds for the assessmentof their abusepotential when crucial data are not available. Becauseof the important role of the CPDD in assessingthe abusepotential of new drugs, the drug evaluation activities of the CPDD are now exclusively funded by NIDA through contracts and grants. This represents a major shift for the CPDD: from 1930until the mid-1970s, the testing program of the CPDD was ended almost entirely by the CPDD itself. Presently, the College funds only the administrative activities of the DEC that are necessaryto coordinate the efforts of the testing centers. In addition to the provision of vitally important testing data and position papers to national governmental/regulatory agencies,the CPDD has had both formal and informal relationships with a number of international bodies regulating drugs of abuse. In this connection, the CPDD has been designated a Collaborating Center of the World Health Organization. In these capacities, the CPDD provides abuse liability data and position papers, which are critically important in international control and drug policy decisions. Finally, the drug evaluation program plays an important role in the design and development of new drugs: the pharmaceutical industry and academic scientists submit the bulk of the compounds evaluated each year for abuse potential and pharmacological properties. Over the past decade,academic scientists and the pharmaceutical industry have submitted over 80% of the compounds assessedby the DEC.
All of the CPDD drug evaluation is done free of chargeto maintain an ‘honest broker’ status as an objective source of information for pharmaceutical firms, individual investigators and various federal and international regulatory agencies.There are two universitybasedgroups involved with the DEC’s evaluation of the analgesic-type of drugs, and four which evaluate the stimulants, depressants and hallucinogens. The analgesicsare examined at the Medical College of Virginia, Virginia Commonwealth University, and the University of Michigan Medical School. The stimulant-depressant testing groups are based in the University of Michigan Medical School, the University of Mississippi Medical School, Washington University School of Medicine, and Louisiana State University Medical Center. Compounds are received by Dr. Arthur Jacobson (NIH, NIDDK), the biological coordinator of the DEC, who is responsible for distributing the drugs and for all correspondence related to them. He codes the compounds for testing under blind conditions. A computerized list of obtained compounds is maintained at the NIH; the code is broken only when complete testing has been carried out and/or when the compound is released for publication. In the past 5 years, compounds have been submitted by pharmaceutical industries, academic institutions, NIH laboratories, NIDA, WHO and the DEA (generally as a result of their confiscation). As mentioned above, the drug evaluation activities of the CPDD are coordinated by the DEC. The DEC consists of the chairperson (currently Theodore J. Cicero, Ph.D), the biological coordinator (Dr. Arthur Jacobson), one representative from each of the testing centers, and three membersof the Board of Directors of CPDD, appointed by the President, who are not affiliated with any of the testing programs. The group meets twice yearly to discussresearchfindings, assimilate results and redirect activities as needed. Prepared by Theodore J. Cicero, Ph.D. Chair, Drug Evaluation Committee
News/ Drug and Alcohol Dependence 38 (1995) 87-90
tion, P.O. Box 2345, Rockville, MD 20852 USA (8007296686). Citations for the two most recent proceedings are provided below: Problems of Drug Dependence 1992,L. Harris (Ed). NlDA Research Monograph Series 132, NIH Publication No. 93-3505, 1993. Problems of Drug Dependence 1993,L. Harris (Ed). NIDA Research Monograph Series 140 and 141 (two volumes), NIH Publication Nos. 94-3148and 94-3749, 1994.
The 2-volume Proceedings of the June, 1994 meeting will be published as NIDA Research Monographs in early 1995. The nature of the Proceedings have changed over time. In early years, full reports of scientific presentations were included, but now that the meetings contain over 600 volunteered papers as well as many symposia, this is no longer feasible. Currently, the Proceedings contain I-page reports of the volunteered presentations. Summariesof the plenary lectures and symposia are also included. One feature of the Proceedingswhich has not changed significantly for many years is the publication of ‘reports’ of the CPDD Drug Evaluation Program. This program, which has been a core component of the College’s efforts for 50 years, was described recently in the CPDD News and Views (Drug and Alcohol Dependence, Volume 34:259-263, 1994). These reports contain what, in many cases,is the sole published report of the results of testing drugs for dependenceliability. The complete set of these reports comprises an enormously valuable scientific resource, particularly in the area of opiate pharmacology. Sponsorship of the Publication of Reviews and Position Papers From time to time the CPDD Board of Directors undertakes to commission special scientific meetings, review papers and position papers on topic of current interest. The CPDD Publications Committee has the responsibility for oversight of the publications which appear under the CPDD’s imprimatur. A list of recent publications sponsored by the College is provided below: Eddy, N.B. (1973)The National ResearchCouncil Involvement in the Opiate Problem, 1928-1971, National Academy of Sciences, Washington, DC. Schuster, C.R. and Harris, L.S. (eds.) (1985) Mixed AgonistAntagonist Analgesics. Special issue of Drug and Alcohol Dependence, 14(3,4). Scientific perspectives on cocaine abuse. (1987) Report on a joint American Society for Pharmacology and Experimental Therapeutics (ASPET)/College on Problems of Drug Dependence (CPDD) conference. The Pharmacologist 29, 20-27. May, E.E.L. and Jacobson, A.L. (1989) The Committee on Problems of Drug Dependence: A legacy of the National Academy of
Sciences.A historical account. Drug and Alcohol Dependence23, 183-218. Fischman, M.W. and Mello, N.K. (eds.) (1989) Testing Drugs for Abuse Liability in Humans. NIDA Research Monograph Series 92, DHHS Publication No. (ADM) 89-1613. Fischman, M.W. and Mello, N.K. (1991) Introduction. CPDD sponsored reviews on methods for testing the abuse liability of stimulant, opioid mixed agonist-antagonist, and anxiolytic and sedative hypnotic drugs in humans. Drug and Alcohol Dependence28, l-2. Foltin, R.W. and Fischman, M.W. (1991) Assessmentof abuse liability of stimulant drugs in humans: A methodological survey. Drug and Alcohol Dependence 28, 3-48. Preston, K.L. and Jasinski, D.R. (1991)Abuse liability studies of opioid agonist-antagonistsin humans. Drug and Alcohol Dependence 28, 49-82. de Wit, H. and Grifliths, R.R. (1991)Testing the abuseliability of anxiolytic and hypnotic drugs in humans. Drug and Alcohol Dependence 28, 83-l 11. Balster, R.L. (1991)Sponsorship of the journal Drug and Alcohol Dependenceby the College on Problems of Drug Dependence. Drug and Alcohol Dependence 29, v-vii. Anabolic steroids: Current and future perspectives on their use and abuse. (1993) Report on joint ASPET/CPDD conference held on June 7, 1991.The Pharmacologist 35, 86-88. College on Problems of Drug Dependence. (1995) Human subject issuesin drug abuse research. Drug and Alcohol Dependence, 37, 167-175. Prepared by Robert L. Baker, Ph.D., Chair CPDD Publications Committee SSDI 0376-8716(95)01123-G
THE DRUG EVALUATION ACTIVITIES OF THE COLLEGE The College on Problems of Drug Dependence (CPDD) has been in existence since 1929 and is the longest standing group in the country concerned with issuesrelated to drug dependenceand abuse. The CPDD has a number of important functions, including organizing the premier annual scientific meeting relating to substance abuse and providing input into public health issuesand policies related to drug abuse and education. One of its more important activities over the past 65 years has been in testing drugs for their abuse liability. Under its current organisation, the CPDD’s dependence liability drug program is overseen by the Drug Evaluation Committee (DEC). The historically pivotal role that the CPDD has played in dependenceliability testing is underscored by the fact that from the 1930suntil the early 197Os,the CPDD was an integral part of the U.S. government regulatory process responsible for assessingthe abuse potential of new drugs prior to any control decision. Although there is no longer a federally mandated requirement that CPDD test compounds with suspected
90
News/Drug
and Alcohol Dependence 38 (1995) 87-90
abusepotential, the Controlled SubstancesAct requires the Secretary of Health and Human Servicesto obtain all relevant scientific data concerning the abuse potential of new drugs prior to a control (scheduling) decision. In practical terms, the Secretary relies upon the National Institute on Drug Abuse (NIDA), the Food and Drug Administration (FDA), and to a lesserextent the Drug Enforcement Administration (DEA) for the provision of thesedata. These agenciesutilize CPDD as a major source of testing information: NIDA, DEA and the FDA routinely request ‘position papers’ regarding the dependenceliability of drugs. Both NIDA and DEA regularly submit compounds for the assessmentof their abusepotential when crucial data are not available. Becauseof the important role of the CPDD in assessingthe abusepotential of new drugs, the drug evaluation activities of the CPDD are now exclusively funded by NIDA through contracts and grants. This represents a major shift for the CPDD: from 1930until the mid-1970s, the testing program of the CPDD was ended almost entirely by the CPDD itself. Presently, the College funds only the administrative activities of the DEC that are necessaryto coordinate the efforts of the testing centers. In addition to the provision of vitally important testing data and position papers to national governmental/regulatory agencies,the CPDD has had both formal and informal relationships with a number of international bodies regulating drugs of abuse. In this connection, the CPDD has been designated a Collaborating Center of the World Health Organization. In these capacities, the CPDD provides abuse liability data and position papers, which are critically important in international control and drug policy decisions. Finally, the drug evaluation program plays an important role in the design and development of new drugs: the pharmaceutical industry and academic scientists submit the bulk of the compounds evaluated each year for abuse potential and pharmacological properties. Over the past decade,academic scientists and the pharmaceutical industry have submitted over 80% of the compounds assessedby the DEC.
All of the CPDD drug evaluation is done free of chargeto maintain an ‘honest broker’ status as an objective source of information for pharmaceutical firms, individual investigators and various federal and international regulatory agencies.There are two universitybasedgroups involved with the DEC’s evaluation of the analgesic-type of drugs, and four which evaluate the stimulants, depressants and hallucinogens. The analgesicsare examined at the Medical College of Virginia, Virginia Commonwealth University, and the University of Michigan Medical School. The stimulant-depressant testing groups are based in the University of Michigan Medical School, the University of Mississippi Medical School, Washington University School of Medicine, and Louisiana State University Medical Center. Compounds are received by Dr. Arthur Jacobson (NIH, NIDDK), the biological coordinator of the DEC, who is responsible for distributing the drugs and for all correspondence related to them. He codes the compounds for testing under blind conditions. A computerized list of obtained compounds is maintained at the NIH; the code is broken only when complete testing has been carried out and/or when the compound is released for publication. In the past 5 years, compounds have been submitted by pharmaceutical industries, academic institutions, NIH laboratories, NIDA, WHO and the DEA (generally as a result of their confiscation). As mentioned above, the drug evaluation activities of the CPDD are coordinated by the DEC. The DEC consists of the chairperson (currently Theodore J. Cicero, Ph.D), the biological coordinator (Dr. Arthur Jacobson), one representative from each of the testing centers, and three membersof the Board of Directors of CPDD, appointed by the President, who are not affiliated with any of the testing programs. The group meets twice yearly to discussresearchfindings, assimilate results and redirect activities as needed. Prepared by Theodore J. Cicero, Ph.D. Chair, Drug Evaluation Committee