Securing Good Health for the Whole Population
Securing Good Health for the Whole Population:
Submission by GeneWatch UK to the Wanless Review
November 2003
GeneWatch UK is a policy research group concerned with the science, ethics, policy and regulation of genetic technologies. We welcome the opportunity to respond to the current review.
The Wanless Review rightly recognised that more success in public health would result in lower projected overall resource requirements (Chapter 7), and that additional resources should be targeted at public health measures such as smoking cessation. The Government has made a number of welcome commitments to public health and to reducing health inequalities. This submission discusses a significant potential threat to this approach. This is the future use of genetic tests to ‘predict and prevent’ common, complex diseases in the general population, including the targeting of health advice (including advice on smoking or diet) and/or medication at those deemed to be at ‘high genetic risk’.
With the exception of some (relatively rare) familial forms of cancer or heart disease (where mutations in a single gene dominate the risk), we believe that genetic ‘prediction and prevention’ is a poor way to seek to improve public health. This strategy is likely to be expensive and difficult to implement (requiring genetic screening of the population), ineffective, unpopular and potentially harmful to health. Our key concerns are:
1. Misleading policy statements and research priorities
The recent Government White Paper on genetics in the NHS (Cm5719-II) has reiterated claims that genetic tests will allow people with certain profiles to avoid foods, chemicals or environmental factors, such as smoking, which are particularly risky for them (para 1.16); that it may be possible in future to test for genes that increase susceptibility to exposures such as cigarette smoke (para 3.5); and that the UK Biobank genetic research project will lead to assessment of the risk of developing the common multi-factorial diseases of later life (para 5.34). The prospects of using genetic tests to produce individual risk profiles are also at the heart of the Medical Research Council’s (MRC’s) Vision for the Future document[1].
2. Poor evidence base
These claims are not supported by the scientific evidence which is now finding that the majority of claimed links between genes and common, complex diseases are not reproducible[2]. For example a recent analysis of genes linked to obesity has found that no gene has yet been confirmed as a susceptibility or modifying locus for central obesity[3]. No link between a common genetic variation and either lung cancer or heart disease (or any other disease) in smokers has been firmly established, nor has any genetic test been shown to be of high predictive value in identifying those individuals most likely to develop these diseases. The idea that common genetic variations are related to common diseases in a simple predictable way is increasingly being questioned[4]. Multiple environmental factors – particularly smoking, diet and exercise, and often infection and pollution – are usually more important than genes[5]. There is also no evidence that genetic test results will empower or enable individuals to change unhealthy lifestyles[6],[7],[8],[9].
3. Undermining public health
Smoking cessation is cost-effective and offers good value for money, particularly compared with other interventions such as statins[10],[11]. Restricting smoking cessation to a minority of supposedly ‘high risk’ individuals has been a long-term aim of the tobacco industry and is likely to be counter-productive in reducing the incidence of smoking-related disease, which is not limited to a minority of individuals with bad genes[12]. Similar problems apply to the idea of targeting dietary advice at individuals who are supposedly ‘genetically susceptible’ to obesity or to common diet-related illnesses such as Type II diabetes or heart disease. At the current rate of increase, more than one in four adults in the UK will be obese by 2010 and at a higher risk of a range of major health problems including heart disease and adult-onset diabetes[13]. The current rise in obesity is not caused by an increase in genes for obesity.
4. Genetic discrimination
Attempting to identify those susceptible to cancer caused by hazardous chemicals or radiation in the workplace or environment could lead to the exclusion of such individuals from jobs and/or insurance, rather than an obligation to improve the environment for all[14],[15],[16]. Liability for diseases in which workplace or environmental hazards play a role may also be transferred from the employer or polluter to the “genetically susceptible”. By restricting access to jobs, insurance and compensation – rather than reducing or eliminating environmental hazards - such an approach would increase ill health, rather than preventing it. Genetic screening for susceptibility to workplace hazards is opposed by the TUC and others as a false option in terms of reducing workplace risks and is unlikely to be publicly acceptable[17].
5. Medicalisation
Pharmaceutical companies have also identified “predictive medicine” (selling genetic tests and medicines together) as an opportunity to expand the drug market[18]. Sir Richard Sykes, former Chairman of GlaxoSmithKline, has predicted that we will see “Genetic testing, symptomatic and pre-symptomatic, for a variety of common diseases such as colon cancer and many mental illnesses” within 10 years and an emphasis on “pre-symptomatic treatment” (for all conditions) in developed countries within 20 years[19]. Many people dislike ‘preventive’ drug taking and prefer lifestyle changes[20] and compliance with long-term medication is usually poor. Unlike some intermediate traits, such as cholesterol levels, genes are not modifiable. Genetic tests could easily become a new example of premature medicalisation, with people labelled as ‘at risk’ for life[21]. Since the predictive value of genetic tests for common, complex diseases is poor, large numbers of healthy people may be given expensive medication without any benefit to health.
6. Lack of joined-up Government or policy evaluation
The Government’s public health strategy may be seriously undermined in future by the scientific research strategy adopted by the MRC and promoted – in the total absence of any evidence or analysis - in the genetics White Paper. As far as we are aware, no assessment has been made by any Government department of the potential costs or pitfalls of targeting preventive measures on the basis of genetic risk.
Recommendations
- The public health strategy adopted should prioritise reducing or eliminating exposures (to smoking, unhealthy diets or pollution) or increasing opportunities for exercise and healthier living and environments.
- Population-based preventive measures (such as banning tobacco advertising, increasing tobacco taxes or tackling smuggling) are generally more effective than individually targeted measures[22]. Where measures need to be targeted this should be done on the basis of identifying high-exposure groups (often linked with health inequalities), or by identifying other modifiable risk factors, not on trying to identify individuals who are supposedly “genetically susceptible” to these exposures.
- No claims relating to the benefits of genetic ‘prediction and prevention’ should be made without first assessing the predictive value of the proposed genetic test, the robustness of the evidence, the numbers needed to screen and treat to prevent one case of disease, the maximum potential impact on the incidence of the disease and the likely reactions of individuals and society to such risk assessments (including potential increases in exposure of the ‘low risk’ group). Costings should take account of the highly contested and resource intensive process of allocating individuals to ‘high’, ‘moderate’ and ‘low risk’ groups in the NHS, and the large uncertainties and likely errors.
- An independent statutory regulator should be set up to assess the marketing claims made for genetic tests and associated interventions (which are not covered by existing legislation[23],[24]).
- The regulatory framework for ‘preventive’ medication should be reviewed, taking into account the public preference for, and cost-effectiveness of, non-medical interventions in public health. Particular attention should be paid to the process of defining and identifying ‘high risk’ groups.
- The public should be involved in setting medical research priorities and health strategies[25],[26]. This is particularly important in public health, where public reactions and compliance are critical to the success or failure of different strategies. Without public involvement it will be impossible to answer the question posed by this consultation: “What are the priorities in public health over the next 20 years that will help us to meet the fully engaged scenario?”.
- The Government should not adopt and subsidise a medical research strategy that undermines its own public health agenda.
[1] .
[2] Ioannidis JPA, Trikalinos TA, Ntzani EE, Contopoulos-Ionnidis DG. Genetic associations in large versus small studies: an empirical assessment. Lancet 2003; 361: 567-571.
[3] Rosmond, R. Association studies of genetic polymorphisms in central obesity: a critical review. International Journal of Obesity 2003; 27,1141-1151.
[4] Wright, AF, Hastie, ND. Complex genetic diseases: controversy over the Croesus code. Genome Biology 2001, 2(8): comment2007.1-2007.8 .
[5] Baird, P (2001), The Human Genome Project, Genetics and Health, Community Genetics, 4, 77-80.
[6] Marteau, TM, Lerman, C (2001), Genetic Risk and Behavioural Change, British Medical Journal, 322, 1056-1059.
[7] Lerman C, Gold K, Audrain J, Lin TH, Voyd NR, Wilfond B, Louben G, Caporaso N. Incorporating biomarkers of exposure and genetic susceptibility into smoking cessation treatment: effects on smoking-related cognitions, emotions, and behavior change. Health Psychol 1997; 16(1): 87-99.
[8] Audrain J, Boyd NR, Roth J, Main D, Caporaso NE, Lerman C. Genetic Susceptibility Testing in Smoking-Cessation Treatment: One-Year Outcomes of a Randomized Trial. Addict Behav 1997; 22 (6): 741-751.
[9] McBride C, Bepler G, Lipkus IM, Lyna P, Samsa G, Albright J, Datta S, Rimer BK. Incorporating genetic susceptibility feedback into a smoking cessation program for African-American smokers with low income. Cancer Epidemiol Biomarkers Prev 2002; 11: 521-528.
[10] Parrott S, Godfrey C. The cost-effectiveness of smoking cessation programs. J Clin Psychiatry Monograph 2003; 18(1), 50-57.
[11] Britton, J. Clinical Practice Guidelines to Promote Smoking-Cessation Treatment: European Guidelines and UK Experience. J Clin Psychiatry Monograph 2003; 18(1), 58-63.
[12] Vineis P, Schulte P, McMichael AJ. Misconceptions about the use of genetic tests in populations. Lancet 2001; 357: 709-712.
[13] National Audit Office (2001), Tackling Obesity in England, 15 February 2001.
[14] US Department of Labor, Department of Health and Human Services, Equal Opportunity Commission, Department of Justice (1998), Genetic Information and the Workplace, 20 January 1998. Available on .
[15] Kaufert, PA (2000), Health Policy and the New Genetics, Social Science and Medicine, 51, 821-829.
[16] Staley, K (2003), Genetic Testing in the Workplace. GeneWatch UK, 2003. Available on .
[17] .
[18] Gilham I, Rowland, T (2001), Predictive Medicine: Potential benefits from the integration of diagnostics and pharmaceuticals, International Journal of Medical Marketing, 2, 18-22.
[19] Sykes, R (2000), New Medicines, the Practice of Medicine and Public Policy, A Nuffield Trust Publication, The Stationary Office, London, pp202.
[20] Lewis, DK, Robinson, J, Wilkinson, E (2003). Factors involved in deciding to start preventive treatment: qualitive study of clinicians’ and lay people’s attitudes. Br Med J, 327: 1-6.
[21] Melzer, D, Zimmern, R (2002), Genetics and Medicalisation, British Medical Journal, 324, 863-864.
[22] Rose, G (1985), Sick Individuals and Sick Populations, International Journal of Epidemiology, 14 (1), 32-38.
[23] Human Genetics Commission (2003), Genes Direct: Ensuring the Effective Oversight of Genetic Tests Supplied Directly to the Public. .
[24] .
[25] Harrison A, New B. Public interest, private decisions: health-related research in the UK. London; The Kings Fund; 2002.
[26] Mayer S. Science out of step with the public: the need for public accountability of science in the UK. Science and Public Policy 2003; 30(3):177-181.