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|Year : 1976 | Volume
| Issue : 2 | Page : 47-49
Rationalisation of Therapeutics ... A confused scene ...
Department of Pharmacology and Clinical Pharmacology Unit, Seth G. S. Medical College and K.E.M. Hospital, Parel, Bombay-400 012, India
U K Sheth
Department of Pharmacology and Clinical Pharmacology Unit, Seth G. S. Medical College and K.E.M. Hospital, Parel, Bombay-400 012
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Sheth U K. Rationalisation of Therapeutics ... A confused scene ... J Postgrad Med 1976;22:47-9
Some years ago, practicing therapeutics was a `taken for granted art' by clinicians. Adequate information on drugs commonly used was available from text books of pharmacology and medicine. This was backed by years of clinical experience learnt in wards and practice. One had periodically to face with a situation where some patients did not 'tolerate' a particular drug or were allergic or hypersensitive to it. In these cases one had to either adjust individual dosage or avoid the use of that particular drug.
This therapeutic scene got complicated and became a little more difficult with introduction of many new drugs in the last three decades. Availability of specifically useful and desirable drugs, made therapeutics more effective and the results more rewarding. But at the same time these desirable drugs also created problems of side effects, some of which were too disturbing and at times even led to fatalities or fatal abnormalities. The result was an increasing amount of care introduced in the use of new drugs and at times confusion in terms of dosages, often under prescribing for fear of side reactions and at times therapeutic nihilism. In scientific circles more basic studies were initiated to clarify the usage of drugs and find causes of mishaps. Such studies also began being demanded by the Drug Control Administration. More close attention began to be focussed on animal studies, and attempts at finding a suitable animal species which would correspond closely to human species in drug actions, metabolic pathways, teratogenic effects, etc. with a hope that such studies would ensure greater human safety. Experience proved that animal studies, carried out howsoever carefully, could not always predict human reactions to the test drug. Animal experiments were good pointers, but still left uncertainty in predictability. It became clearly evident that the best model for study of drugs for man, was man; leading to development of `human pharmacology' or what is now termed as `Clinical Pharmacology'. Studies carried out in a few human beings in depth, would ensure far more reliable data on effective doses, dose related toxic effects, duration of therapeutic effect after single dosage, amount of drug needed to maintain therapeutic efficacy, tolerance, and acceptability. To study this in man, ethics, use . of volunteers, informed consent, formation of hospital drug safety committee, permission from Drug Controller, and a whole gamut of legal and ethical measures to ensure safety of participating subjects, become essential. Drug formulations, drug metabolism, human pharmacokinetic studies, use of labelled compounds, half-life of drugs, etc. became subjects of concentrated studies in the hands of clinical pharmacologists. Equivalent preparations brought in the problem of bioavailability and biovalidity to forefront.
Specialised journals of Clinical Pharmacology, Human Pharmacokinetics, and related subjects, appeared on the medical scene. The mathematics-oriented theoretician, began playing about with theoretical models of drug absorption, drug metabolism, and drug distribution. The Clinical Pharmacology literature became full of language which is so foreign to practicing clinicians. Single and multiple compartment models, K-values, various statistical formulae, often extending over 2 to 3 pages, graphs with various slopes of lines, regression values, and other statistical and mathematical jargon published in these journals today, bewilders and effectively drives away a clinician, from following it, though the subject of Clinical Pharmacology has originated for the benefit of clinicians. Every drug used in combination with another one, seems to produce some interaction or other. In clinical practice patients do get four to five drugs at a time. Clinical Pharmacology journals are often full of detailed discussions on drug interactions, drug induced enzyme inductions, interference with drug metabolism when drug combinations are used in experimental situations in healthy volunteers, which may have marginal practical implications, though they may seem very interesting theoretical exercises. A clinician who reads through this voluminous literature, without correct interpretations about drug interactions that really matter clinically, becomes either afraid or skeptical of using more than one drug that is really needed in a clinical situation or feels all the reported literature unpractical and uses multiple drug therapy with impunity.
Clinical Pharmacology which originated to make therapeutics rational, suggest correct dosage schedule, avoid dangerous drug combinations, and offer explanations for observed side reactions, unfortunately seems to be lost in a maze of complicated, highly theoretical, mathematically oriented discussions, which hardly touch the practical aspects of the problems, or define what findings are really clinically meaningful.
These are some of the reasons why the discipline of Clinical Pharmacology has failed to make a significant impact on the prescribing pattern by clinicians. This is true all over the world to a greater or lesser extent. The lessons are clear for clinical pharmacologists. Arising out of his studies, he should give a clear guidance on what is practical and useful, rather than cover it with a mass of technical details, which are difficult to be followed by clinicians. A clinician needs clear cut information on dosage schedules which will help effective drug interactions which `really' matter in clinical practice, side effects which are of `real' clinical importance, drug combinations which are useful and those which are `positively' dangerous. Such knowledge which a clinician can use in his day-today practice to make his therapeutics effective and safe, will build up his faith in clinical pharmacologists and Clinical Pharmacology as a science and lead to an active collaboration. The therapeutic scene which seems to have been made so confused with a plethora of facts needs to be cleared and made more meaningful by a Clinical Pharmacologist.
Evaluation of new drugs which is of great importance to the clinician seems to attract very few academic clinical pharmacologists. There seems to be an impression that evaluation of new drugs is an exercise of less preferred category for clinical pharmacologists which has only to be done by those employed in pharmaceutical industries. Drug metabolism, pharmacokinetic studies, safety and effective evaluation of new drugs, are equally important, and should attract attention of academic clinical pharmacologists.
A clinician or a pharmacologist whoever desires to function as a Clinical Pharmacologist will have to function as an integral member of the clinical team, helping in improving therapeutic drugs.