For immediate release: 22 April 2002
GeneWatch UK challenges the MRC, Wellcome Trust and Department of Health to allow an independent scientific peer review of Biobank UK
GeneWatch UK today accused the Government of pushing ahead with plans for the controversial £60 million genetic research project Biobank UK (1), without a proper independent review of the science, value-for-money or necessary safeguards for the public. A decision on the project is expected later this month, by review panels at the Medical Research Council and the Wellcome Trust , who will consider the scientific protocol and peer reviewers comments (2).
"Fundamental questions have been widely raised about the scientific validity and purpose of the biobank," said Dr Helen Wallace, "Scientific peer review of the MRCs pet project should not be an inside job. Peer reviewers for such a controversial project should not be chosen solely by those advocating it. Nor should their comments be considered secretly behind closed doors."
GeneWatch called for:
- the projects scientific peer review to be run by a body independent of the Medical Research Council (MRC), Wellcome Trust or Department of Health (who are the major backers of the project);
- an assessment of the projects value-for-money to be made by an independent body;
- a debate in the House of Commons to review the ethical issues and need for legal safeguards.
GeneWatch UK is concerned about both the scientific validity of the project and the lack of safeguards to protect the public from the misuse of genetic information, and has twice called for the project to be shelved whilst these issues are resolved (3). The proposed research has been criticised by many scientists as poorly designed and based on simplistic assumptions (4). GeneWatch UK believes that the proposed scientific protocol (5) is hopelessly inadequate and could lead to spurious links being identified between genes and diseases.
The Wellcome Trust is holding a consultation workshop on the ethics of BioBank UK on 25 April. However, the consultation side-steps the key design changes and safeguards needed to ensure this type of research is beneficial and not harmful to peoples health.
A major concern expressed by the public in recent workshops on the proposal was the "unclear benefits to individuals and society"(6). A key aim of BioBank UK is to develop genetic tests to predict future disease, with a view to giving medicines to healthy people before they get the predicted illness (7). This approach to disease prevention is of doubtful scientific validity and dubious benefit to health. Genetic test results could also be misused by others, such as insurers or employers.
"Ministers are in danger of falling for their own genetic hype in believing common diseases can be predicted from your genes," said Dr Wallace, "The growing epidemic of obesity, for example, is not caused by an increase in obesity genes, but by poor diets and lack of exercise."
Although the Government has promised to address concerns (8), the necessary legal safeguards have not been put in place to protect the public from future misuse of genetic information, and the study design has not been reconsidered in the light of serious scientific criticisms.
Dr Helen Wallace: 01298-871898 or mobile: 07903-311584.
Notes for Editors:
- Biobank UK is being developed jointly by the Medical Research Council (MRC), the Wellcome Trust (http://www.wellcome.ac.uk/en/1/biovenpop.html) and the Department of Health. The plan involves collecting half a million blood samples from volunteers aged 45 to 69, beginning with some pilot studies towards the end of 2002. The idea of making NHS patient information and linked genetic data available to the pharmaceutical industry was originally proposed by the former chief scientist of SmithKline Beecham, George Poste in 1999, and funding was allocated in principle to the Biobank project by the MRC and Wellcome Trust in June 1999. A smaller sum has been allocated by the Department of Health. The biobank is seen by the government as a first step to a national genetic database, including all NHS patients.
- See - www.biobank.ac.uk . At the Wellcome Trust, the review panels recommendations will be considered by the Trusts governors later in the year.
- Press releases and briefings are available on www.genewatch.org .
- "A wild gene chase", New Scientist, 9 December 2000; Clayton, D & McKeigue, PM (2001), Epidemiological methods for Studying Genes and Environmental Factors in Complex Diseases, The Lancet, Vol 358, October 20, 2001.
- "Protocol for BioBank UK: A Study of Genes, Environment and Health", The Wellcome Trust/Medical Research Council and Department of Health, February 2002.
- "BioBank UK: A Question of Trust: A Consultation Exploring and Addressing Questions of Public Trust", Report prepared for the Medical Research Council and Wellcome Trust by People Science and Policy Ltd, March 2002.
- The MRCs view on the need for the project is outlined here.
- Speech by Rt Hon Alan Milburn MP, Secretary of State for Health at the international conference Genetics and Health - a Decade of Opportunity,16 January 2002. Available on http://www.doh.gov.uk/speeches/jan2002milburngenetics.htm