Clinical Pharmacology in Denmark - The early years. Lars F. Gram

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1 Clinical Pharmacology in Denmark - The early years Lars F. Gram

2 Towards Clinical Pharmacology USA National Institute of Health BB Brodie: Variations in drug metabolism explain intra- and interspecies variations in drug response : Clinical Pharmacology Departments in Bethesda, Nashville, San Francisco, Atlanta, London, Stockholm, Textbooks: Goodman&Gillman: The Pharmacological Basis of Therapeutics (1941 -). Melmon&Morelli: Clinical Pharmacology; Basic Principles of Therapeutics ( )

3 Towards Clinical Pharmacology 1960-: Thalidomide Catastrophy: Elicited drug legislations in several countries: USA: Keefauver-Harris Drug Control Act 1962, UK: Medicines Act Pharmacovigilance: Adverse Drug Reaction Committees in most developed countries and in WHO Geneva

4 Major Clincal Pharmacology Journals 1960 : Clincal Pharmacology and Therapeutics (CPT) 1968: European Journal of Clinical Pharmacology (EJCP) 1974: British Journal of Clinical Pharmacology (BJCP)

5 World Health Organization Technical Report Series No. 403.: Principles for the Clinical Evaluation of Drugs. - Geneva 1968 No. 446.: Clinical Pharmacology Scope, Organization, Training - Geneva 1970 Contributors: P. Deniker, L. Dettli, CT Dollery, F Gross, L. Lasagna, F. Sjöqvist

6 World HealthOrganization Europe Symposia: Clinical Pharmacological Evaluation in Drug Control, Copenhagen 1973,1974, 1975, 1976, 1977 Working Group: Clinical Pharmacological Services, Copenhagen 1977 Chairmen: H. Kewitz and EF Hvidberg

7 World HealthOrganization Clinical Pharmacology, Scope, Organization and Training, Geneva 1970 : Demand for clinical pharmacology trained specialists are largely due to 1. The increasing number of drugs 2. The safe and effective use of drugs depends on systematic studies 3. The occurence of several theapeutic disasters (thalidomide and others).

8 WHO: Clinical Pharmacology, Scope, Organization and Training, Geneva 1970 The functions of the clinical pharmacologist : 1. improve patient care by promoting safer and more effective use of drugs 2. increase knowledge through research, 3. pass on knowledge through teaching 4. provide services, e.g. analyses, drug information and advise on design of experiments - -

9 : Lecturer: Pharmacology K.U. EIGILL F. HVIDBERG 1955: M.D : Dr. Sci. Med. (K.U.) : Speciality Internal Medicine : Clinical pharmacology training, Atlanta and Michigan USA.

10 Eigill Hvidberg Clinical Pharmacology - Rigshospitalet: : Weekely reunions on Clincal Pharmacolgy ; present and future : Participants: Per Buch Andreasen Eva Steiness Jens Peter Kampmann Lars F. Gram and others

11 Clinical Pharmacology in Denmark in the 1970ies : MRC Professor of Clinical Pharmacology Copenhagen : Professor of Clincal Pharmacology, Århus, : Professor of Clinical Pharmacology, Odense 1978-: Professor of Clincal Pharmacol.,Copenhagen All postions associated to the Institutes of Pharmacology and in Copehagen also to Rigshospitalet.

12 Clinical Pharmacology (CP) in Odense : Strategies and structures 1978: CP-professor - Department of Pharmacology later within Institute of Medical Biology (IMB) 1988 : CP- lecturer - Dep. Pharmacology 1990: CP separate department within IMB. 1995: 2. professor (Human Pharmacology) 1996: Center of Clincal Pharmacology (CeKFO), MRC grant 1997: CP from IMB to Inst. of Health Service Research : Service functions: DIC, GCP, TDM, CRU,

13 Clinical Pharmacology Departments : Scopes and Strategies Research : fields, methods,, resources Teaching : pregraduate -- postgraduate Services : local - regional - national - international

14 Clinical Pharmacology in Odense Major Research Fields: Antidepressants: Kinetics, TDM, Depression, Pain Pharmacokinetics - Pharmacogenetics Pharmacoepidemiology

15 Clinical Pharmacology in Odense Major Research Fields (2): Pharmacokinetics and pharmacogentics : Kim Brøsen - Disp : Relationship between imipramine metabolism and sparteine oxidation polymorphism.

16 Clinical Pharmacology in Odense Major Research Fields (1): Antidepressants: - Pharmacokinetics - Depression, - DUAG Pain (neuropathy) - Søren H. Sindrup Disp : Antidepressant in the treatment of diabetic neuropathy symptoms

17 Clinical Pharmacology in Odense Major Research Fields (3): Pharmacoepidemiology : Jesper Hallas - Disp : Drug related hospital admissions in subspecialities of internal medicine.

18 Clinical Pharmacology in Odense - International International Meetings Clincal Pharmacology engagements in Psychiatry (IMCPP). Seven Symposia (published), E. Usdin, S.G. Dahl and L.F. Gram.- WHO Working Group on Clinical Pharmacology in Europe Two publications in EJCP J. Birchner, M. Bogaert, M.N.G. Dukes, M. Eichelbaum, LF Gram, H. Hüller, M. Orme, F. Sjöqvist, G. Tognoni. COST- European Cooperation in the field of Scientific and Technical Research. COST Action-B-1 in 3 parts , Danish members: K. Brøsen and LF Gram

19 COST European Cooperation in the fields of Scientific and Technical Research COST- Action B1 DK members: K.Brøsen, LF Gram : Choice and Definition of Healthy Volunteers and Patients for Phase I and II Studies : Metabolic and Kinetic Studies in Drug Research and Development : Managing Variabilty in Kinetics of Drugs during Discovery, Developement and Use. Postion papers and Meetings in Besançon, Manchester, Geneva, Badajoz. Liege,

20 Minestry of Research and MRC : 1995 Five Years Center Grants for Research and Research based Education in Clinical Pharmacology. Three Centers Granted: Copenhagen: Clincal Pharmacology Network of Copenhagen (CPNC) Rigshospitalet, Bispebjerg Hospital, Gentofte Amtssygehus Århus: Clinical Pharmacology Center. Århus University in collabotation witrh hospital sectors in 5 surounding counties (Nordjylland, Viborg, Ringkøbing, Vejle, Århus) Odense : Center for Clinical Pharmacology in Odense (CeKFO) Clinical Pharmacology and several other departments at the

21 Minestry of Research and MRC : 1995 Five Years Center Grant for Research and Research based Education in Clinical Pharmacology. Odense : 6 mio. DKK /year for 5 years : Center for Clinical Pharmacology in Odense (CeKFO) : Clinical Pharmacology Research Unit, Inst. of Public Health, SDU Clin. Pharmacology Section, Dep. Clin. Biochemistry, OUH - Institut of Public Health (General Practice, Health Economics, Epidemiology ) - Institute of Medical Biology (Pharmacology, Physiology) - Odense University Hospital, OUH (Endocrinology, Gastroenterology, Neurology, Oncology, Psychiatry )

22 . Center for Clinical Pharmacology in Odense (CeKFO) Final report february Researh Publications : About 100 original works published in international peer reviewed journals Ph.D. Studies: About 20 completed before 2004 Speciality training in Clincal Pharmacology: About 20 completed before 2004

23 . Center for Clinical Pharmacology in Odense (CeKFO). Final report february HEALTH SERVICE FUNCTIONS established: - Center for Drug Information - TDM service unit - GCP unit - Hospital Drug Committee (reinforced) - Drug Hearings - Written Drug Information (local, national)

24 FIN

25 Clinical Pharmacology in Odense Coworkers who became professors:. Kim BRØSEN Human Pharmacology, SDU Jesper HALLAS Clinical Pharmacology, SDU Søren H. SINDRUP Neurology, SDU Jens SØNDERGAARD General Medicine, SDU Morten ANDERSEN Pharmacoepidemiology, KI, Stckh. Lars BJERRUM General Medicine, KU, Copenhagen David GAIST - Neuroepidemiology, SDU

26 The Drug Scene in the 20. Century Constantly rising problems with : - Increasing number of drugs, indications, drug -combinations, adverse drug reactions, drug interactions, - Increasing costs of drugs, adverse events, surveillance, --- Size and severity of problem intolerable CLINICAL PHARMACOLOGY

27 USA 1962 Congress hearings on the drug industry (Kefauver-Harris) Testemony by professor Walter Modell: A great multiplicity of drugs do harm by their very existence in the drug market. I take the stand that as a general principle everything that adds to the difficulity in dealing with and understanding drug also makes drugs more dangerous. Thus the excessive number of needless drugs constitutes a present danger. We can make the usefull drugs both less dangerous and more efficient by weeding out the useless, the ineffective and the duplicates, and by so doing, make it possible for the physician to learn in depth about potent drugs he will prescribe for his patients.

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