Genomic Medicine
This article was originally published in RAJ Devices
Executive Summary
UK House of Lords seeks evidence for its genomic medicine inquiry
UK House of Lords seeks evidence for its genomic medicine inquiry
A parliamentary subcommittee has initiated an inquiry into genomic medicine and is seeking evidence to ascertain if the UK's existing regulatory framework allows optimal development and translation of new technologies into clinical practice. The genomic medicines subcommittee of the House of Lords science and technology committee will also identify regulatory gaps and compare the policy framework in an international arena1,2.
The subcommittee was appointed on 14 January and is being chaired by Lord Narendra Babubhai Patel, who will lead the inquiry. “We have heard many ambitious predictions of the positive impact genomic medicine could have on a whole range of complex common diseases. Our inquiry will seek to identify what exactly is the state of genomic medical research both within the UK and world-wide,” says Lord Patel. The subcommittee is expected to publish its final report by the end of this year.
The panel members will assess current technologies and their actual and potential impact on clinical practice in the post-genome era. Areas of interest include genetic tests that use genome variation data and the progress that has been made in their regulation. The subcommittee will also inquire into the impact of genomic information on disease aetiology and diagnostic labels.
As genomic information has a huge bearing on advising people on personalised medicine, the subcommittee will investigate existing provisions that seek to ensure that individuals understand the risks and uncertainties involved with such data and whether there should be a regulatory code (mandatory or voluntary) covering the provision of such advice.
It will also examine whether medical information is at present being recorded in a suitable format to allow optimal interpretation of genomic data. It will assess the impact of genomic information on data emerging from biobank projects like UK Biobank, Generation Scotland and others.
It will decide on whether a common public genomic database should be allowed and will identify who should provide the framework for optimal evaluation of data and translational opportunities. Given the pace of technological advancements, it will examine how to “future-proof” healthcare investment in this area.
The deadline for submission of written evidence is 21 April, after which the subcommittee will hold public meetings.
UK scientists, doctors want stricter regulation of genetic tests
Meanwhile, experts from the Royal College of Pathologists and the PHG Foundation, an independent charity, have issued a report calling for the establishment of a “national system” to oversee laboratory diagnostic tests and for the creation of a publicly accessible database containing evidence of test performance, or lack of it3,4.
The report says there are no formal guidelines in place to ensure that individual tests are safe and useful for patients or their physicians. The experts agreed to a set of recommendations for the evaluation and regulation of clinical laboratory tests and complex biomarkers. They suggest creating an independent body for evaluating evidence of test performance and making recommendations about clinical use. The findings and other concerns of the medical experts will feed into the genomic medicine subcommittee's investigation described above.
Following the release of the report, scientists and several practitioners put together a public guide, Making Sense of Testing, to warn against dangers from diagnostic tests that are not researched or adequately regulated5. It says such tests can cause harm, especially in healthy people.
Separately, the BMJ has published an analysis by researchers calling for stricter regulation of genetic tests6. Author David Melzer and colleagues say that DNA variants provide new insight into the cause of diseases, but their clinical applications are still mostly unclear. They are concerned that commercial genetic testing services are being marketed directly to the public in the absence of such knowledge. They warn that using tests without proper evaluation could trigger erroneous treatment, with hazardous results.
References
1. UK Parliament, Lords Committee press notice, 28 February 2008, www.parliament.uk/parliamentary_committees/lords_press_notices/pn280208st.cfm
2. UK Parliament, House of Lords Science and Technology Committee, www.parliament.uk/parliamentary_committees/lords_s_t_select/genomic.cfm
3. Sense About Science press release, 11 March 2008, www.senseaboutscience.org.uk/index.php/site/project/232/
4. PHG Foundation press release, 10 March 2008, www.phgfoundation.org/pages/work7.htm#summit
5. Sense About Science, Guidebook: Making Sense of Testing, www.senseaboutscience.org.uk/pdf/makingsenseoftesting.pdf
6. BMJ, 15 March 2008, http://press.psprings.co.uk/bmj/march/ac590.pdf