Parliamentary Briefing No 3

HUMAN GENETICS AND HEALTH Parliamentary Briefing No.3 November 2002

Biobank UK – A Good Research Priority?

The Government is backing a controversial new genetic research project called ‘Biobank UK’. The project aims to identify the links between genetic and environmental factors in common diseases by studying DNA samples taken from 500,000 45 to 69 year olds. Each person’s genetic The Science and information will be linked with their lifestyle and medical Technology data. Committee of the Biobank UK’s aims are controversial, its science is House of Commons questionable, and there is a lack of legal safeguards to is holding a Public protect those agreeing to take part from misuse of their Scrutiny Session of genetic information. the Medical The Medical Research Council (MRC) and Wellcome Trust Research Council at 4.30pm on announced the allocation of £45 million start-up funding to th Biobank UK in April 2002. The journal Nature has since Wednesday 4 reported that 36 top-rated scientific projects have been December. The rejected by the MRC because of the resources needed to MRC’s role in fund the project1. GeneWatch believes that Biobank UK is a funding Biobank UK poor use of public money and could undermine public trust will be discussed. in medical research. The project should be shelved until the controversies surrounding it have been fully debated and resolved and alternative approaches have been properly assessed.

Biobank UK – good for public health? The aim of Biobank UK is to identify the genetic and environmental factors predisposing individuals to common diseases such as heart disease, cancer and mental illness. Biobank UK’s aims are The MRC states that this understanding would be used to controversial, its predict the likelihood that an individual would develop a science is disease so that medicines could be used to prevent its questionable, and onset rather than as a treatment for symptoms once a there is a lack of legal disease develops2. Lifestyle advice could also be targeted safeguards. at those identified as ‘genetically susceptible’ to future illness. However, this approach to disease prevention is highly controversial. Many scientists believe that prediction of future common illnesses by testing people’s genetic make- up is unlikely to be a successful or cost-effective means of disease prevention. “[The Director of the US National Human Genome Research Institute] and many others have outlined scenarios where all individuals have a battery of genetic tests early in life so that the knowledge of ‘susceptibility’ can be used to avoid development of disease. Biomedical sectors would profit from acceptance of the above approach, but it is doubtful whether it is the approach most likely to increase the health of populations.” Professor Patricia Baird, Department of Medical Genetics, University of British Columbia, Canada3.

Targeting medicines at Targeting medicines at those identified as ‘genetically those identified as susceptible’ (sometimes known as the ‘healthy ill’) also has ‘genetically serious implications. The potential costs of this approach susceptible’ may have never been properly assessed, but it may prove to be prove to be both both wasteful and unsafe (due to side-effects and poor wasteful and unsafe. compliance), ineffective (because medication does not tackle the underlying causes of disease), and extremely costly to the NHS (by vastly expanding the market for medicines for healthy people). There is also a danger of detracting from population-based approaches to disease prevention such as the need to tackle tobacco control, traffic pollution, health inequalities, and the growing incidence of obesity in children. If those identified as not ‘genetically susceptible’ become falsely reassured that they do not need to change their lifestyles this could also have serious negative impacts on public health. Neither the Government nor the MRC has made any assessment of the relative costs and benefits of a genetic approach to disease prevention, compared to alternative population-based measures (such as expanding the Government’s “fruit in schools” programme). GeneWatch believes that there should be an independent assessment of this issue and a full parliamentary debate about the potential implications for the NHS.

“…it is vital that the more conventional approaches of Neither the epidemiology and public health, particularly as they relate to tobacco-induced diseases and other aspects of lifestyle, Government nor the continue to be pursued with vigour. This is particularly important MRC has made any as there are still major uncertainties about the predictive role assessment of the and cost of genomics for controlling common diseases.” relative costs and World Health Organisation, 20024. benefits of a genetic approach to disease prevention. Biobank UK – good science? “The scientific value of focusing on gene-environment interactions has not been established, and in any case, the technical advantages of cohort studies over case-control studies in detection of statistical interactions between genetic and environmental effects are less clear than has been assumed.” David Clayton (Department of Medical Genetics, Cambridge University) and Professor Paul McKeigue (London School of

Human Genetics and Health 2 Parliamentary Briefing No.3 Hygiene and Tropical The science behind Biobank UK importance, Medicine)5. has been criticised by geneticists together and others for three key reasons: with the implications 1. The study design (a ‘cohort’ for stigma rather than ‘case-control’ and study) may be inadequate to discriminati identify the proposed gene- on.” environment interactions. Expert 2. The study is too large to Working allow sufficiently detailed Group to lifestyle and environmental the NHS data to be collected to test Executive hypotheses about the causes and the of complex diseases. Human Genetics 3. Medical records are Commissio inadequate to provide the n7. necessary data for meaningful research. For People will example, only 50% of people be asked to with chronic diseases take donate their their medication as samples to 6 recommended . Biobank UK Although the MRC has reportedly on the already refused funding for several grounds that important research projects the research because of the resources required will benefit for Biobank UK (see above)Error: those who Reference source not found, the are basis on which the project has susceptible been given such high priority is to future unclear. No assessment has been illness made of alternative proposals to because of undertake a smaller but more their genetic detailed project, which may have make-up. more chance of successfully Yet genetic identifying genetic factors in tests disease as well as being cheaper. developed using GeneWatch believes that Biobank Biobank UK UK should undergo a new, could be transparent and independently run used in scientific review process and an future to independent assessment of its discriminate likely value-for-money. These against issues could then be publicly people debated and resolved. identified as ‘genetically The lack of legal safeguards susceptible’ - by refusing “Ethical considerations, and legal, them are fundamental to the whole issue insurance or of genetic testing…The a job for consequences for individuals with regard to insurance and example. employment are also of the greatest There is also concern about b ar. potential a failures of si strict s privacy o and n confidentia w lity for hi genetic c informatio h n, th including e The MRC the need p has to clarify ol reportedly the ic already grounds e refused on which m funding for the police ig several or the ht important Governme b research nt could e projects gain g because of access to r the the a resources informatio nt required for n. e Biobank d UK. Currently, fu there are tu no laws to r prevent e genetic a discriminat c ion, the c Governme e nt has not s signed s and to ratified the th European e Conventio bi n on o Human b Rights and a Biomedici n ne, there k is no r specific e legislation m for the ai protection n Genetic of s tests personal u developed genetic n using informatio cl Biobank UK n, and the e could be used in le The patenting of gene genetic make-up future to ’. sequences is morally is unlikely to be a discrimin objectionable to many successful or ate people and allows cost-effective against unprecedented means of disease people monopolies over future prevention; identified genetic tests and  the serious as treatments, which can scientific ‘genetical stifle future research limitations of ly and innovation and Biobank UK mean susceptib increase costs. that genetic Peopl factors in disease e are GeneWatch believes or drug response also that legal safeguards will be hard to conce need to be in place identify correctly; rned before volunteers are about asked to donate their  the Biobank UK the samples to Biobank UK. project will take potent This is particularly resources away ial for important because the from more useful profite biobank is seen as a and effective ering pilot study for a national medical research; by genetic database,  Biobank UK will pharm potentially including the not contribute aceuti whole of the NHS. directly to the cal development of and “The strategy, of new medicines biotec course, is not to go to a but may allow hnolo national genetic commercial gy database as a first step, companies to go comp the strategy is to join ‘gene fishing’, anies the MRC and the patent gene Wellcome Trust in involv sequences and assembling a large ed in cohort of approximately gain excessive Bioba half a million people… monopolies over nk UK There is an element of future treatments; resear this which is going to  there is a lack of 8 ch . be, as it were, worked legal safeguards Curre out with a large to protect nt research study.” participants from legisla Professor Sir John future misuse of tion Pattison (Director of their genetic does Research and information. not Development, Department of Health), There is a real need for requir 9 e December 2000 . public and peopl parliamentary e to involvement in be Conclusions decisions on such a inform major project. Without GeneWatch UK is proper legal safeguards ed if concerned that: their and open debate, there  prediction of genes is significant potential future common are for a loss of public trust patent illnesses by in medical research. testing people’s ed. References 1 "Top projects suffer as medical funding falters", Nature, 418, 714, 15 August 2002. 2 http://www.mrc.ac.uk/index/public-interest/public-consultation/public-biobank/public-biobank_why.htm . 3 Baird, P (2001), The Human Genome Project, Genetics and Health, Community Genetics, 4, 77-80. 4 World Health Organisation (2002), Genomics and World Health. 5 Clayton, D, McKeigue, PM (2001), Epidemiological Methods for Studying Genes and Environmental Factors in Complex Diseases, The Lancet, 358, 1356-1360. 6 Audit Commission (2001), A Spoonful of Sugar: Medicines Management in NHS Hospitals. 7 “Laboratory Services for Genetics”, Report of an expert working group to the NHS Executive and the Human Genetics Commission, August 2000. 8 Qualitative research to explore public perceptions of human biological samples. Report prepared for the Wellcome Trust and MRC, October 2000. 9 House of Lords Science and Technology Committee, Human Genetic Databases: Challenges and Opportunities, 4th Report, Session 2000-01. Minutes of Evidence.