NEW YORK (GenomeWeb News) – A UK-based bioethics council has issued a new report on consumer genomics that recommends that in order to avoid some possible pitfalls of genetic testing, more information about these tests should be shared between companies, government, and consumers.
The Nuffield Council on Bioethics says direct-to-consumer genetic testing companies are making claims about personalized healthcare that are “overstated and should be treated with caution,” and it recommends that regulators request evidence to back up claims that companies are making and that more information be available to consumers.
The council advises that regulators request evidence about the clinical value of online personalized healthcare offerings, including DTC genomics tests, that government websites provide information about the risks and benefits of personal genetic profiling and buying medicines online, and that government set up accreditation processes for online health records.
“Commercial genetic profiling services may seem to be providing more choice to consumers, but the test results can be unreliable and difficult to interpret and they are often offered to people with little or no genetic counseling or support,” Christopher Hood, a professor of government a the University of Oxford who chairs the Nuffield’s working group that produced the report, said in a statement yesterday.
"Genetic profiling services come with the promise that people will be able to take more responsibility for their health – but it is not clear what that responsibility would imply,” added group member Nikolas Rose, a professor of sociology at the London School of Economics and Director of LSE’s BIOS Centre for the Study of Bioscience, Biomedicine, Biotechnology, and Society.
"You may feel a responsibility to change your lifestyle on the basis of your results, without the help of a doctor to interpret the ambiguous risk statistics. You may feel a responsibility to inform family members, insurers or potential employers of your risks, even though you may never develop the conditions in question," Rose continued.
The Nuffield Council recommends that regulators in the UK pay attention to claims companies are making about their products, even if they are only implied through customer testimonials, and evidence to support those claims should be sought by the departments covering healthcare and medicine products and advertising standards.
Independent research funded by the National Institute of Health Research on the health and psychological impact and effects of multifactor genetic susceptibility testing on individuals should be conducted, including information about how many people are taking using these services, the report argues. Such information would enable consumers to make better decisions about what to do with the information they receive from their test results, according to the report.
The group also recommends that publicly-funded health service websites should include general information about consumer genomics services, including references to potential risks and benefits, questions about clinical validity, the potential of discovering risks for untreatable conditions, issues concerning children in particular, and whether any results could have implications on insurance.
Other information should be provided by these companies, including who is conducting the services, how the results are interpreted, the limits of the tests, how the relative risk is determined, and other related information, the report advises.
At the point of sale, the working group says, genetic testing companies in particular should have customers who will have their DNA analyzed click on a consent statement, and parental consent should be necessary for children.
Consumer genetic testing may have unknown impacts on the healthcare system, and organizations responsible for training healthcare professionals should provide training on best practices for advising patients on such tests.
The Nuffield report also argues that details should be provided to consumers about what will happen to private genetic data if the company should change administrations or ownership.
"People should be aware that other than prompting obvious healthy lifestyle choices such as taking more exercise, eating a balanced diet, and reducing alcohol consumption, the tests are unlikely to inform them of any specific disease risks that can be significantly changed by their behavior,” Hood added.
The Nuffield Council on Bioethics was established in 1991 by the Nuffield Foundation to examine ethical issues surrounding new developments in biology and medicine. It is an independent body funded by the foundation, the Medical Research Council, and the Wellcome Trust.