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Biomedical subjects

Tom Ling

Publications and source records attributed to Tom Ling.

3 recordsLinked to original sources

Pharmacogenetics and uncertainty: implications for policy makers.

Uncertainty for policy makers is not new but the pressure to make decisions under conditions of uncertainty is perhaps greater than ever. The arrival of new scientific developments such as pharmacogenetics offers potentially great benefits (as well as significant risks). They have passionate supporters as well as doubters. The evidence is often extensive but unclear and policy makers may find themselves under pressure to make decisions before they feel that the evidence is compelling. The UK is particularly well placed to play a leading role in the development of pharmacogenetics and is equally well placed to derive the benefits to both health and wealth that could flow from this. However, the uncertainties threaten to overwhelm the capacity of policy makers to act effectively. The uncertainties are both about the context within which the science and delivery of pharmacogenetics is being developed and about the interests that could be served. This paper maps these uncertainties and concludes with some suggestions, drawing on deliberative democracy and futures thinking, as to how policy makers might manage the tensions and dilemmas they face by moving from an unstable, emergent policy arena to a more stable one.

Administrative Personnel↗

Pharmacogenetics: policy needs for personal prescribing.

Pharmacogenetics involves genetic testing of individual patients to guide drug treatment. Proponents argue that pharmacogenetics will achieve major gains in drug safety and efficacy, and revolutionise marketing. Pharmacogenetics also raises several policy concerns, including the need for sound information for clinical decision-making on drug-genetic test combinations. Currently, the pharmacogenetics science base and the rate of emergence of clinical applications are uncertain. Most commentary on pharmacogenetics focuses on new compounds, yet older drugs cause most adverse events. Test regulation in the USA appears fundamentally different from Europe, where evidence of safety or efficacy may not be required. Genetics research is needed as part of post-marketing surveillance systems. In routine clinical practice, computer-based health records with relevant decision support systems will also be needed. Without health policy action, pharmacogenetics could produce a new generation of poorly evaluated tests and drugs, with medicine becoming significantly less evidence-based, leading to rising costs, patient hazard and exclusions of drug-related 'genetic minorities' from evaluated treatments.

Drug Approval↗