Synopsis

Clinical pharmacology comprises all aspects of the scientific stud/ 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, partial agonists, inverse agonists and antagonists. And interference with genetic disease processes is now possible. Increasingly large numbers of substances will deserve 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 potential for good, comes capacity for harm, whether inherent in the substances or as a result of human misapplication.

Successful use of the power conferred (by biotechnology in particular) requires understanding of the enormous complexity of the consequences of interference. Willingness to learn the principles of pharmacology and how to apply them in individual circumstances of infinite variety is vital to success without harm: to maximise benefit and minimise risk. All these issues are the concern of clinical pharmacologists and are the subject of this book.

The drug and information 'explosion' of the past six decades combined with medical need has called into being the discipline, clinical pharmacology. The discipline is now recognised as both a health care and an academic specialty; indeed, no medical school can now be considered complete without a department or subdepartment of Clinical Pharmacology.

The clinical pharmacologist's role is to provide facts and opinions that are useful for optimising the treatment of patients. Therapeutic success with drugs is becoming more and more dependent on the user having at least an outline understanding of both pharmacodynamics and pharmacokinetics. And this outline is quite simple and easy to acquire. However humane and caring doctors may be, they cannot dispense with scientific skill.

• che general aspects of rational, safe and effective drug therapy

• drug therapy of Individual diseases

• introduction of new medicines.

Pharmacology is commonly practised in concert with other clinical specialties. More detailed aspects comprise:

1. Pharmacology

• Pharmacodynamics: how drugs, alone and in combination, affect the body (young, old, well, sick)

• Pharmacokinetics: absorption, distribution, metabolism, excretion or, how the body, well or sick, affects drugs

2. Therapeutic evaluation

• Whether a drug is of value

• Formal therapeutic trials

• Surveillance studies for both efficacy and safety (adverse effects): pharmacoepidemiology and pharmacovigilance

3. Control

• Rational prescribing and formularies

• Official regulation of medicines

• Social aspects of the use and misuse of medicines

• 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 influential studies in the 1930s showed us how to be clinical pharmacologists. In 1952 he wrote in a seminal article:

1 Gold H 1952 'The proper study of mankind is man',

American Journal of Medicine 12: 619. The title is taken from

An Essay on Man by Alexander Pope (English poet,

1688-1744); the whole passage is relevant to modern clinical pharmacology and drug therapy; it is best read aloud whether the reader be alone or in company.

Know then thyself, presume no God to scan,

The proper study of mankind is man,

Placed on this isthmus of a middle state,

A being darkly wise, and rudely great:

With too much knowledge for the sceptic side,

With too much weakness for the stoic's pride,

He hangs between; in doubt to act or rest;

In doubt to deem himself a god or beast;

In doubt his mind or body to prefer;

Born but to die, and reas'ning but to err;

Alike in ignorance, his reason such,

Whether he thinks too little or too much;

Chaos of thought and passion, all confused;

Still by himself abused, or disabused;

Created half to rise, and half to fall;

Great lord of all things, yet a prey to all;

Sole judge of truth, in endless error hurled;

The Glory, jest and riddle of the world!

a special kind of investigator is required, one whose training has equipped him not only with the principles and technics of laboratory pharmacology but also with knowledge of clinical medicine ...

Clinical scientists of all kinds do not differ fundamentally from other biologists; they are set apart only to the extent that there are special difficulties and limitations, ethical and practical, in seeking knowledge from man.2

Pharmacology is the same science whether animal or man is investigated. The need for it grows rapidly as not only scientists, but now the whole community, can see its promise of release from distress and premature death over yet wider fields. The concomitant dangers of drugs (fetal deformities, adverse reactions, dependence) only add to the need for the systematic and ethical application of science to drug development, evaluation, and use, i.e. clinical pharmacology.

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