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Concern over medical tests

Genetic tests which aim to provide information on individual responses to drugs are being regulated in a confusing and possibly dangerous way, say UK researchers. The UK Pharmacogenetics Study Group, a group of collaborating scientists from Sussex, Plymouth, Cambridge, York, Exeter and Nottingham universities are calling for careful changes to EU regulations to protect patients.

Pharmacogenetics is the study of genetic variation and its influence on people's different responses to drugs. Each individual has a unique genetic makeup, and increasingly clinicians are performing pharmacogentic tests in an attempt to predict how a patient will react to treatment. But a new study has concluded that the lack of regulation of these tests, coupled with the fact that they offer only incomplete information, could pose serious risks to patients.

"Pharmacogenetic tests can tell you the extent to which a particular person can metabolise a drug," explains Dr Michael Hopkins, a Research Fellow at SPRU Science and Technology Research at the University of Sussex. "But they don't ensure that a person won't have a negative reaction, because not all toxic reactions are due to genetic traits. Similarly, these tests can tell you if someone has a mutation that may be relevant to a condition. But they don't tell you whether or not this link is tight enough to base prescription information on it. Importantly, this latter step is the bit that isn't covered by regulation. If tests are not fully validated, people will be prescribed drugs that are inappropriate," he says.

"The problem is that pharmacogenetic tests are lumped together with the regulations of all the other genetic tests," says Dr Adam Hedgecoe, a Senior Lecturer in the Sociology Department in the University of Sussex. "European legislation classifies pharmacogenetics as low risk, meaning that they are not overseen by regulatory authorities."

"What we need to do is to introduce a degree of discrimination into the European legislation; to accept that pharmacogenetic tests are not necessarily low risk and to acknowledge that the safety or risks associated with these tests must be judged in their own terms," he says.

The team describe their concerns in their report, "Policy Issues in Pharmacogenetics", which is to be published today following a number of research projects funded by the Wellcome Trust. This finding - and a number of others - are the result of extensive qualitative research over the last 6 years, including interviews with over 300 clinicians, scientists, policymakers, industrialists and regulators in the UK, US and Europe, and analysis of company reports and other information from the largest academic database on the genomics industry, created by team member Paul Martin, at Nottingham University.

"Our conclusions have been drawn based on actual evidence, rather than just a concern or worry," says Hedgecoe. "They are based on what companies are actually doing. We have looked at that the large companies are not investing in: pharmacogenetic tests for drugs already on the market. It is only possible to do this with studies that are based on actual evidence."

"As for the European legislation, as far as I am aware, we are the first to raise the issue of the danger of lumping pharmacogenetic tests with other genetic tests." says Hedgecoe.

Dr Adam Hedgecoe | alfa
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