Report Expects Long Delay Before Personalized Medicines are Widely Available

2005-09-27 - London, England: A report by the Royal Society, the UK's national academy of science, has concluded that the widespread use of personalised medicines, in which patients are prescribed treatments based on their genetic make-up, will not be with us for at least another 15 to 20 years.

In the report, entitled 'Personalised medicines: hopes and realities', the Society concludes that personalised medicines, also known as pharmacogenetics, have a promising future. However, it will be another 15 to 20 years before their use is widespread because of the many gaps in our understanding of how genetics relates to the causes of disease. Current examples of what the future might hold are the approaches used in the treatment of some cancers and the use of a genetic test with a drug so it is only given to patients with the right genes for it to be effective.

The report covers a wide range of issues relating to personalised medicine, including drug development, clinical applications of pharmacogenetic tests, implications for the use of pharmacogenetics, and ethical issues and public dialogue.

Sir David Weatherall, chair of the working group, said: "Personalised medicines show promise but they have undoubtedly been over-hyped. With the human genome sequenced, some people are expecting personalised medicines within a few years, but the reality is still many years away. There are some examples around today, but the complex multiple causes of diseases mean it will be at least 15 to 20 years before a patients genetic make-up is a major factor in determining which drugs they are prescribed."

The report warns that the development of personalised medicines is being hampered by a lack of knowledge among healthcare professionals of the relevant science and a shortage of researchers who have specialised in the areas required to carry out pharmacogenetic research.

The report also recommends introducing financial incentives at the national and European level to encourage pharmaceutical companies to work on developing pharmacogenetic drugs with relatively small potential markets.

Pharmacogenetics is a broad term which encompasses the recognition of subsets of common diseases that can be treated differently, the identification of genes that make drugs effective or harmful and the use of differences in susceptibility to infectious diseases to develop new medicines or vaccines.

Sir David said: "We need to lay the groundwork now if we are ever to realise the potential of personalised medicines. With the NHS (Britain's National Health Service) expected to spend eleven billion pounds sterling on drugs in 2005-6, there is a need to invest in gathering data on how genes influence drug response in the patient population. This is to try and reduce the risk of adverse reactions and to target drugs so they are only given to the patients for whom they will be most effective."

Sir David continued: "Investment needs to come from both the public and private sectors. For new drugs we would like to see better use made of the genetic data collected by pharmaceutical companies during clinical trials. Also, monitoring should continue once products are on the market with the aim of linking genetic variability with clinical outcome. We believe this kind of work should be mandated at the national and European level as an extension to the current system of clinical trials.

"Further private sector input should come from the companies which produce diagnostic DNA tests, because accurate, easy-to-use and reliable tests will be essential for correctly administering the drugs. Where a drug has been in use for some time and is no longer under patent, the onus will be on the Government to fund or provide incentives for carrying out pharmacogenetic investigations where appropriate."

According to the Royal Society's report, in the short term, training and awareness-raising among doctors and other healthcare professionals is needed, as few currently have a clear understanding of the area and the benefits it could bring to patients. There is also a shortage of scientists trained in the appropriate areas to really progress this avenue of research.

Another relevant issue is the gathering and analysis of patient data. This introduces issues of how the information is stored securely, who has access to it and how far it is anonymised. There is recommends that consultation should take place between government and other interested parties, following which an ethical framework for industrial and academic researchers should be outlined where those researchers will be creating or accessing large databases of patients."

Sir David said: "Worldwide, we need greater harmonisation of research practice. Variation in the laws for conducting genetic research between countries makes it difficult to combine data from across the globe into large-scale clinical trials. The guidelines and regulations for conducting genetic research across international borders need reviewing. "Pharmacogenetics may prove valuable in the fight against the big killers worldwide, such as malaria, tuberculosis and HIV. Research is needed to establish the cost-effectiveness and clinical value of this approach for developing countries."