GM Free Cymru

Zero benefit from the GM obsession

This interesting paper from Dr Helen Wallace shows how wasteful the obsession with GM has been, with many millions of pounds poured down the drain, no benefits at all delivered to the consumer, and a multitude of opportunities lost in other more promising fields.

Bioscience for Life? Who decides what research is done in health and agriculture?

By Helen Wallace

A Genewatch Report Email: Website:

March 2010

Executive Summary

This report is an investigation of the shaping of science, innovation and the economy in the UK and Europe. Its starting point is that research funding decisions are political decisions, about how to best spend public money, which institutions to support and what incentives to provide to researchers in academia and industry.

Looking at the biological sciences, in the context of both health and agriculture, the report describes how the idea of the ‘knowledge-based bio-economy’ (KBBE) has become a key driver of research investment in Europe and world-wide. This vision of the future assumes the biosciences and biotechnology will be a major driver of economic growth and at the same time will deliver technical solutions to health, agricultural, social and environmental problems, within Europe and worldwide.

The development of the ‘knowledge-based bio-economy’ In order to stimulate a new bio-economy significant financial and political investments have been made. Scientific institutions and funding systems have been re-structured and new systems of incentives for ‘innovation’ have been devised, with the aim of rewarding researchers who secure patents and venture capital and collaborate with the private sector to create ‘spin-out’ companies and commercialise new products, based on biological knowledge or biologically-based production systems.

These policies and investments have focused on how to exploit the commercial potential of the DNA molecule, which is found inside the cells of living organisms, including micro-organisms, plants, animals and humans.

Driven by the discovery of genetic engineering and the decision to sequence the human genome, the idea of a ‘genetic revolution’ in both health and agriculture has been widely promoted since the 1980s. Agriculture is supposed to be transformed by the ability to produce genetically modified (GM) plants, which are claimed to have higher yields and better nutritional properties, or which can be used as production systems for industrial chemicals, including pharmaceuticals and industrial-scale biofuels (agrofuels). A ‘genetic revolution’ in healthcare has also been promoted, in which knowledge of the human genome is supposed to lead to medicine becoming a more exact science, based on genetic information. In this vision of the future, each person’s individual genome (their ‘genetic make-up’) is stored in electronic medical records, allowing the tailoring of medication and lifestyle advice to a person’s genes and the ‘prediction and prevention’ of disease by treating the (presumed biological) causes, rather than the symptoms. This is sometimes known as ‘personalised medicine’ or as ‘early health’.

Structural changes to R&D systems and policies, designed to exploit the potential of biotechnology and the human genome, began in the US under the Reagan administration. These changes were mirrored by the Thatcher and Major governments in the UK, and by the European Commission (EC), which identified biotechnology as a key driver for future growth. In Europe, investments in biotechnology research began in the early 1980s, and in 1987 the Single European Act explicitly gave the EC formal power in the fields of research and technology. A decade later, in 1996, the OECD (Organisation of Economic Co-operation and Development) began to promote the idea of the ‘knowledge-based economy’, in which the rich country members of the OECD were presumed to be able to compete with emerging economies such as India and China by patenting and trading ‘intellectual property’ rather than manufactured goods. Biotechnology was seen as a key ‘technology platform’ in the knowledge-based economy, and the idea of the ‘knowledge-based bio-economy’ (KBBE) was adopted as central to European growth. The ‘vision’ of GM crops as new production systems – allowing the creating of ‘nutritionally-enhanced’ crops and the production of industrial chemicals, including pharmaceuticals and agrofuels – has been supported by officials and policy makers in the European Commission and adopted as central to the KBBE.

In Britain, the New Labour Government, elected in 1997, invested heavily in the KBBE as the presumed basis of future of economic growth. The funders of New Labour known as the ‘biotech barons’, and other key supporters of biotechnology as an engine for growth, were appointed to task forces designed to identify the policies needed for future competitiveness. They promoted the idea of a ‘genetic revolution’ in both health and agriculture and advocated policies which strengthened protection for ‘intellectual property’ (IP), opposed regulation, and attempted to create the ‘informed consumer’ (presumed to be convinced of the benefits of GM crops, and to identify collection, storage and analysis of their DNA with major benefits to their health and to society). In the 1998 Comprehensive Spending Review the then Chancellor Gordon Brown announced “the biggest ever Government-led public/private partnership for science”: this was the start of a major Government collaboration with the Wellcome Trust, designed to help Britain win the race to commercialise the fruits of the Human Genome Project.

The information contained in medical records stored in the NHS was identified as Britain’s ‘unique selling point’ (USP) in the knowledge- based economy, and a plan to create a central database of electronic medical records (‘the Spine’) was adopted and funded. The UK Biobank research project was established as a pilot study to begin linking health data to DNA and to include information from people’s genomes in their electronic medical records, with the aim of ‘predicting and preventing’ major diseases such as heart disease and type 2 diabetes.

The idea of a ‘genetic revolution’ in both health and agriculture was promoted at the highest levels in the British Government: for example, in the then Prime Minister Tony Blair’s speech at the joint announcement with President Clinton of the completion of the first draft of the human genome in June 2000; and in Blair’s major speech on science to the Royal Society in 2002.

The bio-economy: delivering on promises? The benefits of the ‘bioeconomy’ to the UK and EU have been extremely limited: • The net value of the bio-economy worldwide has been estimated to be zero or negative: with only two US medical biotech companies (Amgen and Genentech) and one US agricultural biotech company (Monsanto) making significant profits. • Only two types of GM crops have been commercialised on any scale: insect-resistance and herbicide-tolerance. These crops are grown largely in North and South America for use in animal feed and (subsidised) industrial-scale biofuels (agrofuels). • Concerns remain about environmental impacts, food safety, liability for contamination of non-GM crops and foods, and the extent of corporate control of seeds exercised through patents and licensing agreements. • A number of new biotech drugs have been developed, but Britain’s only blockbuster biopharmaceuticals were discovered in the 1980s. • Most new biotech ‘spin-out’ companies from UK universities are never profitable and are a net drain on the economy: they employ only 1,000 people in total. • Genetic tests of multiple genetic factors are poorly predictive of common diseases and most adverse drug reactions: none are sufficiently predictive or useful to meet medical screening criteria for use in the general population.

It is difficult to find exact figures on the cost to taxpayers of the political commitment to investing in a new bio-economy. The main costs identified are:

Time and money In the UK alone, at least 60 Government policy initiatives and reports have been commissioned to support and develop the KBBE over the last 15 years, with many more initiatives focused on the broader context of the knowledge-based economy in general. Estimates of taxpayers’ money spent or allocated include: • £12 billion plus allocated to implementing the UK centralised system of electronic medical records known as the ‘Spine’, with the aim of implementing a ‘genetic revolution’ in healthcare; • Euros 13.1 billion in national and regional government subsidies for biotechnology across the 15 old EU member states between 2002 and 2005, of which Euros 1.4 billion was spent by the UK. The breakdown across the EU was about 2.06 billion, 690 million, and 525 million Euros a year on health, agricultural and industrial biotechnology respectively. This level of spending continued but has not been documented subsequently. • An additional unspecified amount from the EU’s DG Research.

Skills lost Shortages in a wide range of skills in health and agriculture R&D have been identified as a result of an over-emphasis on the role of molecular biology: including: pharmacology, human and plant physiology, plant pathology and general botany, plant-soil interactions, weed science, and entomology/pest biology. Opportunity costs The UK and EU have failed to develop new competitive economies as a result of reliance on the idea that a new biotech economy would be developed. More practical solutions to existing problems have been neglected, as has much R&D that is not seen as contributing to the KBBE (such as agricultural extension services in England and Wales, which used to provide on-the-ground scientific support to farmers). Public sector plant breeding, which used to generate income as well as bringing significant international economic benefit and increases in food production, has been abandoned in favour of GM crop research, which has delivered zero return.

The evidence cited in this report suggests that the idea of the KBBE is failing in at least four ways: · It is not delivering, and cannot deliver, the promised revolutions in health, agriculture and sustainability. Indeed, in many situations, the false solutions that it offers may undermine alternative approaches and create significant opportunity costs. · It is not delivering, and cannot deliver, a ‘race to the top’ for Europe’s economies. · By locking ‘knowledge’ into intellectual property, it fixes old ideas (such as the idea of genes as major risk factors for common diseases) and seeks to market them, distorting research priorities and promoting misinformation, rather than stimulating creativity. · The system of investment prioritises ‘technologies of control’, designed to monopolise markets and maximise profits. · Such technologies also increase dependency (for example, dependence on scientific risk assessment to determine which foods are safe and which human genetic variants are dangerous; and dependence on the performance of technologies such as seeds supplied by distant corporations, or databases managed by government institutions). In general, people are likely to be sceptical that technologies that reduce their control over their own lives are of benefit to them. · The uncritical promotion of (often barely credible) technical solutions for major social problems, combined with the loss of independent expertise to inform policy and regulation, is undermining democratic values and trust in institutions.

This does not mean that biotechnologies and the biosciences cannot contribute to health, agricultural or sustainability objectives, or to the economy. However, it does mean that it is necessary to re-think the whole idea of the ‘knowledge-based bio-economy’ (KBBE) and its role in the knowledge-based economy in general.

Structural problems with R&D investments The key features of the knowledge-based bio-economy distort the market in ways that make research investment decisions unaccountable to either market forces or democratic processes. Problems include that: • ‘pre-competitive’ subsidy, via research funding decisions, lacks accountability and transparency and hides political and commercial commitments to the bio-economy and to imaginary markets presumed to be created in the future; • public-private partnerships and public procurement policies shift investment risks and externalities onto the taxpayer, intermediaries such farmers, doctors and health services, and members of the public; • ‘light-touch’ regulation fails to address market failures and protect health or the environment; • a ‘cycle of hype’ drives research investment decisions, which become disconnected from reality; • policy commitments are not debated but are instead ‘sold’ to the public as if they were the inevitable consequences of science and progress.

Both the UK Government and the European Union have adopted a ‘vision- led’ approach to research investment decisions in which a future world without hunger, or free from cancer and other disease, features prominently. Enthusiasts have portrayed implementing these visions as a ‘race’ to capture the economic and social benefits of genomics and biotechnology: policy analysis and responsiveness to external critiques are then considered luxuries that cannot be afforded. Thus, the technical, commercial and economic failure of the bio-economy has generally been attributed to unfavourable policies – particularly ‘over-regulation’ and weak IP protection – and public ‘ignorance’, rather than the underlying R&D strategy and its failure to appreciate the complexities of biology, society, markets, agriculture and the environment. This results in an agenda that is self-perpetuating, as there is no mechanism to re-appraise existing policies or to stop throwing good money after bad.

The long time-scales and substantial public investments involved in the bio-economy have led to political ‘entrapment’ in particular innovation strategies. As a result, significant amounts of taxpayers’ money continue to be invested in failed or highly speculative approaches. For example, nitrogen-fixing and salt-tolerant GM crops were promised nearly 30 years ago: many scientists are sceptical that such products can be delivered and even enthusiasts predict that several decades more investment would be needed before any prospect of delivery. There is widespread recognition amongst geneticists that most diseases in most people, and many adverse drug reactions, are too complex and too dependent on environmental factors to be predictable by screening people’s genes. Yet, significant investments of taxpayers’ money continue to be made with a view to integrating scans of people’s genomes into electronic medical records to ‘predict and prevent’ disease.

Alternative ‘on-the-ground’ approaches to improving health and farming have been side-lined, starved of funding, or even axed altogether, leading to significant opportunity costs due to the failure to implement existing knowledge and best practice in areas such as public health and farmland management.

Political entrapment also means that rejection by the market is treated as an obstacle that must be overcome, with more ‘education’ (of the public and/or medical professionals) and policies which seek to make adoption of the relevant technologies inevitable. In adopting this approach, policy makers undermine the knowledge and debate which they and society at large rely on to make informed decisions and to make realistic and informed appraisals of techno- scientific claims. They become dependent on a narrow circle of advisors who promote misleading ‘visions’ of how new technologies will deliver magic solutions to social and environmental problems. They also undermine public trust in scientific and political institutions, by creating unrealistic expectations and by hiding the real motivations for public statements and decisions.

The existing system of investment in research in health and agriculture has wasted billions in taxpayers’ money and delivered nothing in terms of a viable new ‘bio-economy’. It has also exacted a high price in human lives due to wasted opportunity costs by acting as a distraction from more immediate, lower-cost alternatives. This is partly because ensuring that existing treatments and a varied, balanced diet reach everybody would save a lot more lives than any possible technological developments; and partly because the system distorts the research agenda away from human needs as well as from the broader development of scientific knowledge and understanding. The problem is not that commercial interests should not play a role in funding and helping to drive (at least some) R&D investment, or that technology (including biotechnology) has no positive applications, but that the system of policies and incentives created to drive the ‘knowledge-based bio-economy’ is deeply flawed.

The main findings of this report are that:

Major investment decisions in R&D and in research infrastructure are being made by the EU and by the UK Government without due diligence – including scientific diligence – or cost-benefit analysis. ‘Optimism bias’ – leading to significant underestimates of social, environmental and economic risks – is rife. Yet the UK Treasury does not apply its rules for economic assessment or appraisal to major R&D investments, unlike other major infrastructure projects. A one-off assessment of the costs and benefits of highly uncertain future technologies is unlikely to help, but ongoing appraisals and analysis, combined with a greater awareness of the assumptions on which claims of progress have been based, would reduce the risk of throwing ‘good money after bad’.

Expertise from a narrow range of commercial interests and perspectives seen as key to the KBBE has been integrated into the scientific institutions, government departments and research councils where research funding decisions are made. These advisors are likely to influence research strategies and choose research priorities from their own perspective, without being answerable to taxpayers or responsive to public concerns. This is taken to a new level by the European Technology Platforms, where research strategies in food, health and agriculture are being determined by the ‘vision’ of a small number of advisors to the relevant commercial sectors.

There has been a loss of expertise in important areas needed to achieve societal aims such as improved health and more sustainable agriculture. Whole areas of research and development, such as farmland management and public health, have been neglected. A lack of ‘counter- expertise’ also makes policy-makers and the public vulnerable to misleading claims about what can be delivered by genomics and biotechnology.

The financial, social and environmental risks of public-private partnerships are largely borne by the general public and the taxpayer, who are excluded from decision-making. For example, the ‘Plants for the Future’ EU Technology Platform was developed by the biotech industry to set the agenda for funding from DG Research. Its commitment to winning more public subsidy in order to develop new GM crops was never debated by voters or consulted on. The desire to build a genetic database of the whole British population underpinned the UK Government’s decision to invest £12 billion in building a centralised system of electronic medical records. The Government has never been open about why it made this decision, nor did it assess the costs, supposed benefits, or risks to privacy.

A small number of enthusiasts for particular approaches dominate the decision-making processes for R&D investments. These individuals often have vested interests in promoting these approaches. They have led a ‘vision-based’ approach to policy-making, which involves promoting claims, rather than assessing their validity or their dependence on (often out-dated) assumptions about biology. Barely credible claims are often made that the development of genetics and genomics, including GM crops and large-scale genetic databases, will eliminate problems as diverse as hunger, cancer, crime, obesity and adverse drug reactions. Typically no independent analysis of these claims is made and critics are dismissed as ‘anti-science’ or ‘anti-progress’.

Political commitments to particular approaches and the role of vested interests are often hidden and rarely open to proper public scrutiny. For example, the UK Government and the EU’s DG Research have both endorsed a paradigm shift in medicine to personalised prevention based on genetic risk prediction. At various times, this approach has been supported by the tobacco, nuclear, chemical, food and pharmaceutical industries as a means to expand the market for medicines and functional foods and to avoid controls on unhealthy products and pollution, by promoting genetic explanations for cancer and obesity. There is no evidence that it is of benefit to health or likely to be cost-effective.

The research funding system encourages the patenting, promotion and marketing of scientific discoveries, even though most published research findings are later refuted by further research. This undermines the concept of the scientific method as a means of formulating and testing hypotheses with experimental evidence, and replaces it with a system that encourages exaggerated claims, including to policy makers and investors and to the public via the media.

Science and innovation has become increasingly disconnected from the users of research. This is most striking in food and farming research, where agricultural colleges, extension services for farmers, and traditional plant breeding have largely disappeared and research priorities are driven by what can be patented by commercial seed companies or ‘add value’ for food manufacturers.

There are likely to be significant opportunity costs as a result of poor investments made via the current research funding system. Billions of pounds and euros are being spent on ineffective or spurious solutions to major social, environmental, health and economic problems: including hunger and obesity.

The public is becoming increasingly alienated and disillusioned and is sceptical that research priorities are being set in the public interest or that they will deliver economic benefits. For example, the Science Horizons project found that it is widely assumed that policy- makers in government and big business are not candid with citizens and that technology is being developed by industry and/or government in order to make profits, rather than in response to societal needs.

Recommendations There is an urgent need to re-assess what has been delivered by the major political and financial investments made in the bio-economy over the past three decades, and to review whether current funding structures, institutions and review mechanisms are fit-for-purpose to deliver genuine solutions to the problems that we face.

Review of the research funding system should lead to a major overhaul, including significant reforms to improve the scientific and technical advice available to the UK Government and to the European Union; reform the patents system; and re-structure funding institutions and systems of incentives for researchers. Objectives should include: · More democratic decisions about research funding priorities and a more diverse research agenda; · Greater accountability and scrutiny of major research investment decisions: including economic assessments and appraisals, scrutiny of scientific and technical assumptions, and active steps to prevent political ‘entrapment’ in research agendas based on false assumptions and misleading claims; · A role for public engagement in setting research questions and priorities: including consideration of a variety of alternative approaches to addressing problems, and greater democratic accountability for science policy decisions; · More public engagement in research itself, involving closer co- operation between universities, communities and civil society organisations; · More funding for research which does not necessarily benefit large corporations but may deliver other benefits: including economic ones (for example, public health research, and research into improving agro-ecological farming methods); · Funding for ‘counter-expertise’ and multi-disciplinary research which can identify long-term scientific uncertainties and regulatory gaps; · Ensuring a thriving scientific culture that can analyse, critique and develop the theoretical concepts that often underlie decision-making, and which are key to developing new understandings; A commitment to take public opinions into account in decisions about science and innovation, including methods to ensure full consideration of the broader social, environmental and economic issues associated with adopting particular approaches and technologies.