Current applications of pharmacogenetics

Our knowledge of pharmacogenetics can be applied in two main areas - (a) in improving the use of existing commonly prescribed drugs and (b) in the development and use of new drugs by the pharmaceutical and biotechnology industries. a) Current drugs

The ability to individualize the use of currently used drugs will not only permit the identification of individuals vulnerable to drug side effects but, perhaps more importantly, will allow us to identify those patients who will or will not respond to a particular drug treatment. As discussed above, there are certain research areas where this is of vital importance, e.g. in the treatment of cancer, but also for other diseases such as the control of serum cholesterol with statins or the use of non-steroidal anti-inflammatory drugs, where a significant proportion of the population do not respond to these agents. For certain drugs there are already prescribing guidelines; for example, in the treatment of childhood leukaemia with 6-mercaptopur-ine (Armstrong et al., 2004) and in the use of Glivec (Vastag, 2004) and Herceptin (Bell et al., 2004). There is, however, still an urgent need for new studies to identify genes which influence drug metabolism and efficacy, and to correlate genetically determined variation in these genes with treatment response. It is, of course, possible that such pharmacogenetic studies could be incorporated within other existing large population-based studies such as deCODE (www.decode.com) and the UK Biobank (www.ukbiobank.ac.uk). However, unless the requisite protocols and infrastructure for pharmacogenetic analysis are embedded in the conceptual and design phases of these studies it will be impossible to collect this information retrospectively.

Although pharmacogenetic approaches to increase our understanding of individuality in drug response have enormous implications for routine medical practice, studies on currently used drugs are unlikely to be sponsored by the pharmaceutical industry and it therefore increasingly becomes the responsibility of central Government to support this type of research at an international level. One way to carry out these studies effectively is to use a population-based approach where pharmacogenetic factors that determine patient response can be correlated with genetic background and detailed computer-based information on drug prescribing and outcome in individual patients. b) The development of new drugs

The pharmaceutical industry is acutely aware of the need to consider the implications of pharma-cogenetics on the discovery and use of new drugs. It has important implications for the industry as, in the first instance, many new drug targets are identified as susceptibility genes and are therefore by definition polymorphic in the human population. A number of major pharmaceutical companies now routinely screen new drug targets to establish the extent to which genetically determined variation is of significance to new drug development programmes. If a drug target is polymorphic, this information may be used to identify individuals who will respond differently to drug treatment. Although this information is not currently publicly available, new FDA (Food and Drug Administration) guidelines in the USA will require the inclusion of pharmacogenetic information as part of future regulatory submissions for all new drugs (Lesko and Woodcock, 2002).

The most appropriate time to establish whether a polymorphism in a new drug target is an important determinant of therapeutic efficacy is during Phase 3 clinical trials, where blood samples are routinely collected from all trial participants and where the incorporation of additional genotype analysis will therefore be relatively routine and will not have significant cost implications. The ability of pharmaceutical companies to use genetic information to subdivide their patient populations into respon-ders and non-responders may, on the one hand, reduce their market share, as it may not be possible to design new ''blockbuster'' drugs suitable for all patients. However, it is also possible that genetic testing may identify a subpopulation of responders, which would permit limited drug registration. The concept that future new drugs may be licensed together with an appropriate genetic test is attractive, although it would be necessary to limit prescription to areas/countries where both genetic testing and appropriate qualified interpretation is routinely available.

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