Report blasts 'hype' over personalised medicines

By Wai Lang Chu

- Last updated on GMT

Related tags: Clinical trials, Genetics, Human genome, Pharmacology

According to a recent report, pharmacogenetics is unlikely to
become a reality within the next 15-20 years having been 'hyped' by
the media, who are unaware of the many gaps in current
understanding of how genetics relates to the causes of disease.

Pharmacogenetics, tailoring drug treatments to a person's genetic profile is also known as personalised medicines. It is said to be the future of drug research and development, paving the way for individualised treatment on an unprecedented scale.

However, media coverage of this new phenomenon has been quick to present the future ahead of schedule. In reality, the field is still in its infancy, burdened by the expectation placed upon it.

Critics have also expressed reservations about the ability of this technology to fulfil such claims, what it might cost, how soon it could be achieved and if it would impact negatively on the modern healthcare system.

Although understanding how genetic factors influence a person's response to a drug could make new and existing treatments safer and more effective, the report predicted that pharmaceutical companies would still continue to favour drugs that work well regardless of genetic differences, but where this was not possible pharmacogenetic medicines, with an associated diagnostic test, will increasingly play an important role.

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.

Most current drugs are not effective for 100 per cent of the population and some work in as few as 30 to 50 per cent of cases.

According to the report, large-scale clinical trials are needed to assess the cost-effectiveness of developing and using pharmacogenetic therapies. Investment needed to come from both the public and private sectors.

For new drugs, these trials will be conducted by the pharmaceutical industry, but for existing medicines, Government funding in public-private partnerships between medical research charities, the Department of Health and the pharmaceutical and diagnostic industries should encourage these studies.

Monitoring should continue once products are on the market with the aim of linking genetic variability with clinical outcome. Work of this kind would need to be mandated at the national and European level as an extension to the current system of clinical trials.

The report, entitled: Personalised medicines: hopes and realities,'​ published by the UK's national academy of science, The Royal Society, highlighted the issue of whether healthcare systems in the UK have the resources to implement such technologies.

Doctors, nurses and pharmacists would require a much stronger basic training in fundamental human genetics, as well as guidance on how to offer and interpret key tests

"Personalised medicines show promise but they have undoubtedly been over-hyped, said Sir David Weatherall, chair of the working group.

"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,"​ he added.

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.

With the UK's National Health Service (NHS) expected to spend £11 billion on drugs in 2005-6, there is a need to invest in gathering data on how genes influence drug response in the patient population.

"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,"​ Weatherall said.

"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."

Weatherall said that worldwide, greater harmonisation of research practice was needed. In addition, 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 would 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,"​ he said.

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