Committee Clerk Trade and Industry Committee
House of Commons
7 Millbank
London SW1P 3JA
leesd@parliament.uk
Date: 19/04/02
To the Members of the Committee, we submit the following comments, using some of the points outlined in your press release, on the current and future prospects for the UK biotechnology industry:
1) The contribution which biotechnology industries can make to relative GDP growth and the performance of the UK as a knowledge-based economy;
Biotechnology industries, whilst potentially contributing to economic growth, need to be viewed warily as not all hold the promise of success. In this respect, we caution against diverting too much investment or public money to much hyped but as yet unproven technologies, such as genetically engineered crops, cloning, embryonic stem cells, genetic engineering of crops and foods and genomics.
We specifically draw your attention to the fact that there is serious scientific debate ongoing with respect to some of these technologies. That the science is still uncertain calls into question whether they will really deliver the promised benefits or not. Consider the following:
Animal cloning by somatic cell nuclear transfer: The UK has long seen animal cloning as its special province. The apparent success of Dolly the sheep persuaded many this was a way forward for the industry. Yet cloning success rates are low and abnormalities rampant. Experience from Australia's Research and Development Institute was that only 6 out of 30 cloned sheep survived [1]. Cloned monkey embryos have a similar failure rate [2].
Neither has the expected drug delivery from such technology materialised. PPL Therapeutics, who cloned Dolly, has pushed back the commercial launch of alpha-1-antitrypsin, developed to treat hereditary emphysema, as a consequence of problems at the trial stage. Last year the US Food and Drug administration told PPL that it had concerns about the future of the drug. Now biotechnology analysts are beginning to doubt whether the technology can actually work. A spokesperson for ING Barings recently stated they have had doubts about the viability of transgenic animals for some time. To date there have been no medicines issued from this branch of biotechnology [3].
Genetic engineering of crops and foods: GM food technology is also the subject of debate. For every report produced touting its benefits, there are others warning of its instability and failure. In North America problems with gene transfer via cross-pollination have compromised non-GM crops and have shattered communities as farmers have been taken to court for supposed theft of patented seeds. [4]. The UK is the EU's biggest consumer of organic foodstuffs, a market set to top £10.5 bn. per year in the next five years [5]. Yet GM's is placing the organic status of at least a hundred organic farms at risk of contamination as a consequence of field test sites [6]. A report by English Nature warns of the inevitability of "gene stacking" (where several engineered traits coincide in one organism as a result of gene transference) should herbicide resistant crops be released here [7].
In addition, the risks and uncertainties, particularly over biosafety, associated with some of these technologies warrant a precautionary approach. For example, the insurance industry in the UK and Australia is unwilling to write cover for GM related risks. Aware of events in North America, UK insurers have deemed that farmers put out of business by genetic pollution will get no compensation. Land agents are advising farmers not to get involved with GM crops [8]. In the last week Monsanto and Aventis CropScience admitted that some genetically modified canola seeds that have not been approved in the United States might have found their way to farmers' fields [9].
Genomics: The outlook here also looks bleak. As genes in themselves tell us little about the vast majority of diseases the hope is that studying how genes interact with environment and lifestyle will bring returns on the huge outlay. This will be both time-consuming and expensive. Having already spent hundreds of millions of pounds on the Human Genome Project the government has drawn up plans for a "BioBank" where 500,000 volunteers are to contribute DNA, medical records and details of lifestyle to a number of special centres devoted to correlating this mass of data [10].
Meaningful results could take decades to materialise, if ever. Just days ago Professor Nick Hastie, Director of the Medical Research Council's human genetics unit told the Edinburgh Science Festival that therapies developed from genomics would not be effective in protecting us against common diseases. Craig Venter, former director of Celera Genomics, who raced the Genome Project for completion of the sequence has stated "we simply do not have enough genes for this idea of biological determinism to be right [11]."
Further, even if efficacy at the therapeutic level were attainable, GDP growth from biotechnology could only be gained through unethical means such as patented gene sequences, royalties charged on gene tests designed to predict susceptibility to disease, resistance to developing countries granting compulsory licensing or parallel imports [12]. There is a growing concern amongst members of the public about such issues. The ethical and social dimension of these technologies should not be ignored. Ethics and social responsibility are not divorced from science, and science must act in the interest of public good. Public perceptions very much affect the investment climate.
2) The relationship between industry, higher education and research, including the effectiveness of the Government's Science and Technology programmes in creating a positive environment for the industry;
The relationship as it stands inhibits the free exchange of information. As research findings are patented, ostensibly to aid exploitation through placing a monopoly on a given artifact or method, researchers have become increasingly guarded so as not to transgress those patents. Consider the findings from two pieces of research from the US published recently:
A report in Nature presented a survey of US laboratories' adoption and use of genetic testing for hereditary haemochromatosis, and drew attention to the consequences of patents on genetic testing after finding that US labs were withdrawing the tests over worries about potential court cases and costs. Citing the pending court case in Europe over BRCA1 &2 involving Myriad Genetics and the Curie Institute, the report argued that the same could happen over haemochromatosis testing and pointed out that four patents relating to the iron overload disease are pending. New human genes are being patented as rapidly as they are discovered. As these patents cover the clinical diagnoses of mutations as well as the sequences for potential therapies both tests and treatments for diseases are discouraged. The net result is that neither the holders of the patents nor the public benefit from such arrangements [13].
Another survey, this published in the Journal of the American Medical Association has found that data sharing in human genetics research is hampered by concerns over intellectual property rights.
Of 1,240 geneticists surveyed by a team from the Institute of Health Policy at Massachusetts General Hospital almost half claimed they had been refused access to information by a co-worker in the past three years.
The survey suggests that material transfer agreements inhibit information sharing, as universities require researchers to ensure that the institution retains intellectual property rights to any work deriving from results before they are handed over [14].
There are clear indications that the relationship between higher education and industry leads to waste of public funding as materials and procedures developed at public expense are claimed by industry. A report issued by the US watchdog Public Citizen late last year challenged the US pharmaceutical industry's claim that drugs cost an average of $500m each to develop. This figure is used by industry to justify tight patent controls and high prices. The report pointed out that pharmaceutical companies select choice research from publically funded labs. As a consequence R&D costs per drug are closer to $100m. According to an internal NIH document obtained by Public Citizen 50% of the research resulting in the top five drugs of 1995 was carried out in the public sector [15].
Patenting laws that favour "last in line" property rights have led to absurdities such as that involving the gene coding for the EPO protein, first identified in 1977 after two decades of US government-funded research. The exclusive rights to the gene were awarded to Amgen in the mid-eighties. Amgen then extended their rights to include applications for the gene unrecognised at the time of the original patent application [16].
Genomics has further encouraged this trend, enabling companies to buy up broad gene sequences and gene fragments. This has also applied to plant genes, and has lead to concerns about food security for many millions of people.
The emergent science of Proteomics will further compound the issue as patents for genes and patents for proteins will inevitably overlap. This will bog down research in endless legal complications and court cases.
Conclusion: The hope is that investment in biotechnology could improve GDP both directly and indirectly. Firstly, gaining an advantage in an emergent industry could bring the UK plenty of profits. Secondly, improvements in the health of the nation resulting from the medical application of biotechnology would improve productivity generally, and increase total work hours thus improving the health and the wealth of the nation.
However the search for a medical application of biotechnology merely distracts research funding from developing alternative methods of treatment. In particular the environmental impact on health and the consequences of lifestyle are ignored (unless they are refracted through genomics as in the BioBank UK project). Neither the Medical Research Council nor the Wellcome Trust are interested in complementary or alternative medicines [17]. Yet millions regularly use such treatments and they are time-honoured and potentially profitable methods of treatment. Haemochromatosis, discussed below in reference to patenting and expensive therapies and often seen as a disease of the 21st century can be treated by phlebotomy, or bleeding, a technique used in the dark ages. Huge increases in late-onset diabetes, coronary illnesses and various cancers are all consequences of lifestyle and environment. A paradigm shift to preventative medicine would do more for GDP by creating more work hours annually.
The tide is turning against agricultural biotechnology. Problems with cross-pollination, gene stacking and crop instability are compounded by public resistance and the unwillingness of the supermarkets to sell such produce. The UK has the largest proportion of organic consumers in the EU. It is estimated that spending on organic produce in Europe will double over the next five years to £10.5bn [18]. The recent "Curry" report on the future of farming in England saw organic agriculture as the way forward for a sustainable food future [19]. Diet, of course, also connects up with sickness rates and therefore with GDP. Recent research suggests that consumption of organic foodstuffs actively lowers the risk of heart disease, strokes and cancer [20].
We therefore recommend that investment in both medical and agricultural applications of biotechnology be kept to a minimum and that greater funding be directed towards research into alternative and traditional medicine, and research into the influence of environment, lifestyle and diet on health.
Comments by Nicholas Papadimitriou on behalf of ISIS.
Institute of Science in Society, London.
Article first published 02/06/02
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