Pharmacogenetics: ethical issues

New medicines

The introduction of pharmacogenetics will have an impact on the way in which clinical trials are designed and managed. Some clinical trials already include the collection of genetic information and this practice is likely to become more widespread.

How will pharmacogenetics be used in clinical trials?

Pharmacogenetic analysis could influence the design of clinical trials. Smaller groups of genetically similar participants could be selected, potentially leading to more reliable research results. People who are likely to suffer adverse reactions from a new medicine could be identified and excluded from trials, protecting research participants. However, there is currently not enough information available to reliably assess the impact of pharmacogenetics on the design of clinical trials, and therefore also on the cost of developing medicines.

Will pharmacogenetic testing become mandatory in trials?

It is difficult to predict at this stage just how widespread the use of pharmacogenetics in research will become. Regulatory requirements or concern about litigation could put pressure on companies to include pharmacogenetic analysis in trials. However, this approach may not always be feasible or appropriate. One possibility is that pharmaceutical companies will collect genetic information at the time of a trial, but not analyse the data unless it becomes necessary.

We conclude

The appropriate use of pharmacogenetics in clinical trials should be promoted. Collection of samples for possible future pharmacogenetic analysis should be encouraged.

Will pharmacogenetics be used to improve existing medicines?

Pharmacogenetics could also be applied to existing medicines to improve the safety and efficacy of prescribing. The importance of such research depends on a number of factors:

• How widely used is the medicine?
• What is the nature and severity of any adverse reactions?
• How accurate would a pharmacogenetic test be?
• Do alternative treatments exist?

It is unlikely however that the pharmaceutical industry would have a sufficient economic incentive to carry out this research, especially if the medicine is not covered by patent protection. The Department of Health has recently announced that new funding of £4 million will be directed towards pharmacogenetic research over the next three years.

We conclude

Pharmacogenetic research on existing medicines should be encouraged. Funding and support should be made available within the public sector and public-private partnerships should be encouraged.