Personal genetic profiling services lack evidence for claims

October 12, 2010

Direct-to-consumer personal genetic profiling services that claim to predict people's health risks by analysing their DNA are often inconclusive and companies that sell them should provide better information about the evidence on which the results are based, says the UK Nuffield Council on Bioethics, in a new report on the ethics of so-called personalised healthcare services.

The report says that claims that these services are leading to a new era of 'personalised healthcare' are overstated and should be treated with caution. The Council recommends that regulators of these services and advertising regulators should request evidence to back up the claims made by companies.

The services are marketed to healthy people as a way of finding out their risk of developing serious conditions such as diabetes, heart disease, Parkinson's disease and some cancers. But people taking the tests are faced with complicated risk data in their results and may experience undue anxiety, or be falsely reassured, says the Council.

Professor Christopher Hood, chair of the Working Party that produced the report, said:

"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 counselling or support".

"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 behaviour," added Professor Hood.

Currently there is no overarching system of regulation for personal genetic profiling. The tests are mainly provided by companies based in the US, and they can cost up to US $2,000. During its inquiry, the Council wrote to providers of genetic profiling services to try to find out how many people are currently using them, but the companies were not willing to share this information.

The Council recommends that genetic profiling companies should provide more information about their services to consumers before they buy, such as their limitations, the fact that the results may require interpretation by a doctor or geneticist, and which other third parties may have access to the data arising from the test. Government-run health websites should provide information about the risks and benefits associated with personal genetic profiling services, including whether or not it could be necessary for people to inform insurance companies of the results.

Professor Nikolas Rose, one of the authors of the report, said:

"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."

"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," added Professor Rose.

To make these recommendations, the Working Party weighed up whether the need to reduce harm was strong enough to propose interventions that compromised people's freedom to pursue their own interests.

The report also considers another so-called personalised healthcare service - direct-to-consumer CT, MRI and ultrasound body scans as a form of 'health check-up' for people without pre-existing symptoms, a service which some companies offer at a cost of more than £1,000.

CT scans carry serious physical risks from the radiation involved, especially if whole body scans are used, and carried out on repeated occasions.

The Council says that the commercial sale of whole body CT scans as a health check for people without prior symptoms of illness should be banned, as any potential benefits do not justify the potential harms caused by the radiation. It also suggests that companies offering scans as part of a health check should be regulated to ensure they are meeting standards of quality and safety.

The Council recommends that doctors should receive specific training on giving advice to patients about direct-to-consumer genetic profiling and body imaging services, and about making referral decisions on the basis of these tests.
-end-
NOTES TO EDITORS

1 For further information contact:

Sarah Bougourd
Communications Officer
Nuffield Council on Bioethics
28 Bedford Square, London WC1B 3JS
Tel: +44 (0)20 7681 9619
Mob: +44 (0)7821 449 725

Email: sbougourd@nuffieldbioethics.org
Web: www.nuffieldbioethics.org

2 Background

The Nuffield Council on Bioethics established a Working Party in 2008 to examine the ethical issues raised by new developments and technologies that promise us more personalised healthcare. The group included members with expertise in medicine, science, law, philosophy, ethics, and health policy.

To inform its deliberations, the Working Party: The Working Party developed an ethical framework consisting of five ethical principles against which each of these new developments were examined, and on which the recommendations are based.

The principles are:

1. private information should be safeguarded
2. individuals should have freedom to make their own choices
3. the state should act to reduce harm
4. public resources should be used fairly and efficiently
5. social solidarity (the sharing of risks and protection of the vulnerable)

The Working Party also looked at the implications of consumerisation in healthcare and of people being encouraged to take more personal responsibility for their health.

The Working Party's conclusions and recommendations are published today in the report Medical profiling and online medicine: the ethics of 'personalised' healthcare in a consumer age.

3 The report

Copies of the report Medical profiling and online medicine: the ethics of 'personalised' healthcare in a consumer age will be available to download from the Council's website www.nuffieldbioethics.org from Tuesday 12th October 2010.

4 Video footage

A video interview with Professor Christopher Hood and Professor Nikolas Rose is available on request, for more information please contact Sarah Bougourd (see above).

5 Working Party members

Professor Christopher Hood FBA (Chair)
Gladstone Professor of Government and Fellow, All Souls College, University of Oxford

Professor Kay-Tee Khaw CBE FRCP
Professor of Clinical Gerontology, University of Cambridge School of Clinical Medicine, Addenbrooke's Hospital

Dr Kathleen Liddell
Senior Lecturer, Faculty of Law, University of Cambridge

Professor Susan Mendus FBA
Professor of Political Philosophy, University of York

Professor Nikolas Rose
Martin White Professor of Sociology, BIOS Centre for the Study of Bioscience, London School of Economics and Political Science

Professor Peter C Smith
Professor of Health Policy, Imperial College Business School, London

Professor Sir John Sulston FRS
Chair, Institute of Science, Ethics and Innovation, University of Manchester

Professor Jonathan Wolff
Professor of Philosophy, University College London

Professor Richard Wootton
Director of Research, Norwegian Centre for Telemedicine and Integrated Care, Tromsø, Norway

6 About the Nuffield Council on Bioethics

The Nuffield Council on Bioethics examines ethical issues raised by new developments in biology and medicine. Established by the Nuffield Foundation in 1991, the Council is an independent body, funded jointly by the Foundation, the Medical Research Council and the Wellcome Trust. The Council has achieved an international reputation for addressing public concerns, and providing independent advice to assist policy makers and stimulate debate in bioethics.

The Council has previously reported on the ethical issues raised by pharmacogenetics, the study of the effects of genetic differences between individuals in their response to medicines. See: Pharmacogenetics: ethical issues (published September 2003) available at http://www.nuffieldbioethics.org/pharmacogenetics.

Nuffield Council on Bioethics

Related Health Articles from Brightsurf:

The mental health impact of pandemics for front line health care staff
New research shows the impact that pandemics have on the mental health of front-line health care staff.

Modifiable health risks linked to more than $730 billion in US health care costs
Modifiable health risks, such as obesity, high blood pressure, and smoking, were linked to over $730 billion in health care spending in the US in 2016, according to a study published in The Lancet Public Health.

New measure of social determinants of health may improve cardiovascular health assessment
The authors of this study developed a single risk score derived from multiple social determinants of health that predicts county-level cardiovascular disease mortality.

BU study: High deductible health plans are widening racial health gaps
The growing Black Lives Matter movement has brought more attention to the myriad structures that reinforce racial inequities, in everything from policing to hiring to maternal mortality.

Electronic health information exchange improves public health disease reporting
Disease tracking is an important area of focus for health departments in the midst of the COVID-19 pandemic.

E-health resource improves men's health behaviours with or without fitness facilities
Men who regularly used a free web resource made significantly more health changes than men who did not, finds a new study from the University of British Columbia and Intensions Consulting.

Mental health outcomes among health care workers during COVID-19 pandemic in Italy
Symptoms of posttraumatic stress disorder, depression, anxiety and insomnia among health care workers in Italy during the COVID-19 pandemic are reported in this observational study.

Mental health of health care workers in china in hospitals with patients with COVID-19
This survey study of almost 1,300 health care workers in China at 34 hospitals equipped with fever clinics or wards for patients with COVID-19 reports on their mental health outcomes, including symptoms of depression, anxiety, insomnia and distress.

Health records pin broad set of health risks on genetic premutation
Researchers from the University of Wisconsin-Madison and Marshfield Clinic have found that there may be a much broader health risk to carriers of the FMR1 premutation, with potentially dozens of clinical conditions that can be ascribed directly to carrying it.

Attitudes about health affect how older adults engage with negative health news
To get older adults to pay attention to important health information, preface it with the good news about their health.

Read More: Health News and Health Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.