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
The birth of a new protein
20.10.2017 | University of Arizona
Building New Moss Factories
20.10.2017 | Albert-Ludwigs-Universität Freiburg im Breisgau
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.
It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...
17.10.2017 | Event News
10.10.2017 | Event News
10.10.2017 | Event News
20.10.2017 | Information Technology
20.10.2017 | Materials Sciences
20.10.2017 | Interdisciplinary Research