CLINICAL PHARMACOLOGY 2003 (PART 4)

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Clinical pharmacology comprises all aspects of the scientific study of drugs in man. Its objective is to optimise drug therapy and it is justified in so far as it is of practical use. Over recent years pharmacology has undergone great expansion resulting from technology that allows the understanding of molecular action and the capacity to exploit this. The potential consequences for therapeutics are enormous. All cellular mechanisms (normal and pathological), in their immense complexity are, in principle, identifiable. What seems almost an infinity of substances, transmitters, local hormones, cell growth factors, can be made, modified and tested to provide agonists,...

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2 Clinical pharmacology SYNOPSIS circumstances of infinite variety is vital to success without harm: to maximise benefit and minimise Clinical pharmacology comprises all aspects of risk. All these issues are the concern of clinical the scientific study of drugs in man. Its pharmacologists and are the subject of this book. objective is to optimise drug therapy and it is The drug and information 'explosion' of the past justified in so far as it is of practical use. six decades combined with medical need has called into being the discipline, clinical pharmacology. The discipline is now recognised as both a health Over recent years pharmacology has undergone great care and an academic specialty; indeed, no med- expansion resulting from technology that allows the ical school can now be considered complete with- understanding of molecular action and the capacity out a department or subdepartment of Clinical to exploit this. The potential consequences for thera- Pharmacology. peutics are enormous. All cellular mechanisms The clinical pharmacologist's role is to provide (normal and pathological), in their immense com- facts and opinions that are useful for optimising the plexity are, in principle, identifiable. What seems treatment of patients. Therapeutic success with drugs almost an infinity of substances, transmitters, local is becoming more and more dependent on the user hormones, cell growth factors, can be made, modified having at least an outline understanding of both and tested to provide agonists, partial agonists, pharmacodynamics and pharmacokinetics. And this inverse agonists and antagonists. And interference outline is quite simple and easy to acquire. However with genetic disease processes is now possible. humane and caring doctors may be, they cannot Increasingly large numbers of substances will deserve dispense with scientific skill. to be investigated in therapeutics and used for altering physiology to the perceived advantage (real or imagined) of humans. But, with all these developments and their poten- • the general aspects of rational, safe and effective drug tial for good, comes capacity for harm, whether therapy inherent in the substances or as a result of human • drug therapy of individual diseases misapplication. • introduction of new medicines. Successful use of the power conferred (by bio- technology in particular) requires understanding of the enormous complexity of the consequences of Pharmacology is commonly practised in concert interference. Willingness to learn the principles of with other clinical specialties. More detailed aspects pharmacology and how to apply them in individual comprise: 37
2 CLINICAL PHARMACOLOGY 1. Pharmacology a special kind of investigator is required, one • Pharmacodynamics: how drugs, alone and in whose training has equipped him not only with the combination, affect the body (young, old, principles and technics of laboratory well, sick) pharmacology but also with knowledge of clinical • Pharmacokinetics: absorption, distribution, medicine ... metabolism, excretion or, how the body, well Clinical scientists of all kinds do not differ or sick, affects drugs fundamentally from other biologists; they are set 2. Therapeutic evaluation apart only to the extent that there are special • Whether a drug is of value difficulties and limitations, ethical and practical, in • How it may best be used seeking knowledge from man.2 • Formal therapeutic trials Pharmacology is the same science whether animal • Surveillance studies for both efficacy and or man is investigated. The need for it grows rapidly safety (adverse effects): as not only scientists, but now the whole community, pharmacoepidemiology and can see its promise of release from distress and pharmacovigilance premature death over yet wider fields. The con- 3. Control comitant dangers of drugs (fetal deformities, adverse • Rational prescribing and formularies reactions, dependence) only add to the need for the • Official regulation of medicines systematic and ethical application of science to • Social aspects of the use and misuse of drug development, evaluation, and use, i.e. clinical medicines pharmacology. • Pharmacoeconomics. If it is desired to single out a pioneer clinical pharmacologist it would surely be Harry Gold1 (1899-1972) of Cornell University, USA, whose in- GUIDETO FURTHER READING fluential studies in the 1930s showed us how to be Brater D C, Daly W J 2000 Clinical pharmacology in clinical pharmacologists. In 1952 he wrote in a the middle ages: principles that presage the 21st seminal article: century. Clinical Pharmacology and Therapeutics 67: 447-450 1 Gold H 1952 'The proper study of mankind is man', Breckenridge A1995 Science, medicine and clinical American Journal of Medicine 12: 619. The title is taken from pharmacology. British Journal of Clinical An Essay on Man by Alexander Pope (English poet, Pharmacology 40:1-9 1688-1744); the whole passage is relevant to modern clinical pharmacology and drug therapy; it is best read aloud Breckenridge A1999 Clinical pharmacology and drug whether the reader be alone or in company. regulation. British Journal of Clinical Know then thyself, presume no God to scan, Pharmacology 47: 11-12 The proper study of mankind is man, Dollery C T 1996 Clinical pharmocology: future Placed on this isthmus of a middle state, prospects for the discipline. British Journal of A being darkly wise, and rudely great: With too much knowledge for the sceptic side, Clinical Pharmacology 42:137-141 With too much weakness for the stoic's pride, He hangs between; in doubt to act or rest; 2 In doubt to deem himself a god or beast; Self-experimentation has always been a feature of clinical In doubt his mind or body to prefer; pharmacology. A survey of 250 members of the Dutch Born but to die, and reas'ning but to err; Society of Clinical Pharmacology evoked 102 responders of Alike in ignorance, his reason such,, whom 55 had done experiments on themselves (largely for Whether he thinks too little or too much; convenience) (van Everdingen et al 1990 Lancet 336:1448). A Chaos of thought and passion, all confused; spectacular example occurred at the 1983 meeting of the Still by himself abused, or disabused; American Urological Association at Las Vegas, during a Created half to rise, and half to fall; lecture on pharmacologically-induced penile erection, when Great lord of all things, yet a prey to all; the lecturer stepped out from behind the lectern to Sole judge of truth, in endless error hurled; demonstrate personally the efficacy of the technique The Glory, jest and riddle of the world! (Zorgmotti A W 1990 Lancet 336: 1200) 38
CLINICAL PHARMACOLOGY 2 Grahame-Smith D G 1991 Clinical Pharmacology. Reidenberg M M 1999 Clinical pharmacology: the Roles and responsibilities in academic research. scientific basis of therapeutics. Clinical British Journal of Clinical Pharmacology 32:151 Pharmacology and Therapeutics 66: 2-8 Laurence D R 1989 Ethics and law in clinical Walley T 1995 Drugs, money and society. British pharmacology. British Journal of Clinical Journal of Clinical Pharmacology 39: 343-345 Pharmacology 27: 715-722 39
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