NOTE: Biotech related extracts from the recent in-depth report about the power of commercial interests within science and technology: Science and the Corporate Agenda, by Stuart Parkinson and Chris Langley of Scientists for Global Responsibility. The report considers how the commercialisation of science "brings with it a wide range of detrimental effects, including bias, conflicts of interest, a narrowing of the research agenda, and misrepresentation of research results. It examines these effects across five sectors: pharmaceuticals; tobacco; military/defence; oil and gas; and biotechnology." For reasons of space and to assist ease of reading, GMWatch has removed the extensive references available in the original report from the extracts below.
EXAMPLE EXTRACTS: The issue of the failure to declare potential conflicts of interest is illustrated by a study of 79 papers in molecular biology (including areas in biotechnology) submitted to the journal Nature in a six-month period in 2005. This study shows that, in two-thirds of the papers in which authors had patent applications or company affiliations which might be considered to present competing financial interests, the authors did not disclose them. Only four papers in the study actually declared that some of the authors had competing financial interests.
A study for the US Department of Agriculture examined the biotechnology research that was promoted through the domination of a small group of companies in the seed industry. The study used the number of field-trial applications for GM crops from private firms and divided this number by the sales from private industry of seed for each major crop. This calculation provides a measure of 'research intensity' which can be compared across the different crops. Using this methodology for corn, soybeans and cotton indicates that, as the seed industry became more concentrated in the 1990s, private research intensity declined. The authors thus concluded that reduced competition led to less R&D, reducing innovation even in gene-based agricultural research rather than increasing it. This is despite claims from the biotechnology corporations to the contrary.
... In summary, commercial influence on biotechnology R&D is considerable, contributing to a strong focus on genetic technologies and a lack of adequate consideration of alternative approaches in fields such as agriculture and medicine. This is in an area that abounds with complex, ethical issues, and is characterised by a great deal of scientific uncertainty.
Extracts from Science and the Corporate Agenda
On consolidation of the seed and seed processing industry:
... acquisition programmes began with the 'life science' businesses buying up large seed companies, an example being Monsanto's buy-up of Cargill's seeds in 1998. Biotechnology innovation requires that companies design suitable processing and seed markets (pathways) to take full advantage of the R&D in which they have invested. The pathway is part of the sector’s business model and shapes the form of biotechnology that develops and the investments undertaken. Dominant transnational companies like Monsanto, Dow and DuPont are characterised not only by their technological integration within a given market but also, as we discuss later, by their simultaneous dominance of multiple markets within agriculture. For instance Cargill, the largest grain exporter in the USA (and probably according to available data the world), is also dominant in soybeans and cotton.
On problems related to commercial involvement in biotechnology:
... corporate-backed lobby groups not only try to influence the public acceptance of GM techniques and products, but also help shape government attitudes and the research agenda. For instance the Agricultural Biotechnology Council (set up by BASF, Monsanto, Dow Agrisciences and Syngenta) has access to the ear of government; the first chair of the Council was Stephen Smith, the former head of Syngenta Seeds. The Council has organised, through the public relations outfit Lexington Communications, a pro-GM publicity campaign targeting public perception of the technology. CropGen is another biotechnology industry-funded lobby group with a determinedly pro-GM stance; it calls itself an "education and information initiative for consumers and the media".
On the lobby group Sense About Science:
In February 2009 the UK group Sense About Science (which was set up in 2002 in order to "promote evidence and scientific reasoning in public discussion") published a new guide to GM crops and food entitled Making sense of GM. The publication was written by a group of scientists and focused solely upon the claimed benefits of GM for increasing crop reliability and yield. The guide did not discuss any of the broader scientific, ethical, social or economic aspects of GM technology and practice. Far more worryingly, whilst there were brief biographies of the authors in the guide, there was no mention that many were linked to UK institutions and groups closely connected to the GM industry.
Other aspects of Science About Science (SAS) are also noteworthy in this context. Recent accounts show that SAS receives approximately half of its income from business, with large donors including the biotechnology company AstraZeneca. The founder and current Chair is Dick Taverne, whose background is in law, politics and business rather than science. He has been very critical of the attention given to a number of environmental concerns, and has, for example, derided opponents of GM crops, criticised the conclusions of the IPCC (the UN's advisory body on climate change), and accused environmental groups of 'eco-fundamentalism'. Furthermore many of the Board of Trustees of SAS do not have a background in science, and a number are involved with the ‘LM network’ which lobbies for GM food, human cloning, denial of global warming, and against restraints on corporate activity.
Such groups help to create a pro-industry backdrop both to the public understanding of the issues surrounding GM technology and to funding decisions made regarding agricultural research priorities. Public relations companies play a central role in the 'information war' which projects positive claims about GM technology and marginalises informed criticism (they play similar roles in other industrial sectors areas too). Both Lexington and the Bivings Group have been active in attempting to subdue GM-critical voices. For instance, Bivings was involved in a campaign to have Nature retract a paper it published, which alleged that native Mexican corn had been contaminated by GM pollen. Recent research has confirmed that Mexican corn has been contaminated by genetically modified plants.
On corporate involvement in biotech and effects on plant breeding research and development:
Corporate involvement in biotechnology has steered R&D (and seed supply) to focus largely on GM crops and away from more traditional plant breeding including virtually ignoring agroecological methods, such as organic farming and other forms of 'pro-poor' approaches to farming. The dominance of GM approaches, especially in the hands of large powerful companies like Monsanto, marginalises other forms of agriculture and food provision. Such technologies are primarily for large-scale commercial farmers of the rich world. The use of patents and intellectual property rights reinforces this approach, and ignores the needs and choices of the public and farmers alike.
Corporate control and ownership of seeds has profound effects upon food security, the research agenda across the biosciences, and the economic standing of farmers, especially in the poorer countries. In July 2005, Phillips McDougall, a UK-based agricultural business analyst, quoted the value of the global commercial seed market at $19 trillion and estimated that the top ten companies control around 51 per cent of the whole market. Despite continued controversy and the lack of public acceptance of GM plants in many parts of the world, GM seeds are gaining market share. In 2005 Phillips McDougall estimated that GM seeds represented about 25 per cent of the total value of the global commercial seed market, yet only a few per cent when measured by acreage.
On Monsanto's lobbying activities:
Let us spend some time now looking at the activities of Monsanto, which is the world’s leading producer of GM seeds. Monsanto is a major seed and herbicide business and dominates the global market for GM crops with specific traits. Monsanto has joined other major agribusiness companies in supporting third-party organisations such as the Biotechnology Industry Organisation, the International Food Information Council, the Agricultural Biotechnology Council and others who have vigorously promoted GM crops as a safe and appropriate technology. Monsanto's influence is projected through the R&D it funds and undertakes, the seeds it produces, and the arguments it uses to persuade government and those in science that gene technologies should be the predominant means of providing food, a corporate view neatly packaged by lobby groups, third parties like those mentioned above and public relations companies like Lexington.
Reduced competition leads to less innovation:
This high level of market dominance and financial power wielded by large companies like Monsanto has shaped the global agricultural research agenda. Work on more sustainable ways of growing food has become marginal in the face of such high technology approaches.
A study for the US Department of Agriculture examined the biotechnology research that was promoted through the domination of a small group of companies in the seed industry. The study used the number of field-trial applications for GM crops from private firms and divided this number by the sales from private industry of seed for each major crop. This calculation provides a measure of ‘research intensity’ which can be compared across the different crops. Using this methodology for corn, soybeans and cotton indicates that, as the seed industry became more concentrated in the 1990s, private research intensity declined. The authors thus concluded that reduced competition led to less R&D, reducing innovation even in gene-based agricultural research rather than increasing it. This is despite claims from the biotechnology corporations to the contrary.
On lack of testing on health and environmental impact of GM crops:
A great deal of the antipathy towards GM crops shown by the public in the UK and in other European countries concerns the potential health and environmental impacts of such crops. With powerful industrial lobbies strongly influencing both governments and scientific research, there is much distrust of the safety assurances given in this area. The four principle areas in which safety assessments are undertaken are: (a) direct health effects toxicity; (b) the ability to provoke an allergic reaction; (c) the stability of the gene which is inserted into the crop (or animal); (d) any unintended effects that are triggered by the inserted gene.
Many of the tests that have been undertaken to assess these effects depend upon animal models of dubious relevance to humans. [GMWatch comment: Animal testing is the first step in safety testing for food additives and medicines. If no problems show up, then human trials are the next step. Testing of GM foods is voluntary, often does not include rigorous animal feeding studies, and does not include human studies.] Long-term assessment of humans consuming GM food is either not being undertaken or is so over-simplified as to risk missing complex effects. A robust large scale study in places where people are already consuming GM products (such as the USA) could give data about the long-term consequences of GM crops in the diet over time and in different populations. However, trying to unpick the many complicating factors within human populations with respect to diet and its influence is notoriously difficult. Nevertheless this does not remove the need for there to be firm data on human health consequences of consuming GM food.
The movement of GM genes into conventional crops or related species in the wild (outcrossing) as well as the mixing of non-GM with GM crops may have an unintended effect on food safety and security. Evidence that this risk is real comes from the case of a GM maize harvest that was only approved for animal feed use being mixed with maize for human use in the USA. In order to be sure of the human and environmental safety and impact of GM crops, it is essential to have in place robust postmarketing monitoring of GM food products. There are also difficult issues concerning who carries the liability for environmental harm should the monitoring pick up problems. Simple assurances from GM lobbies and governments should not stand in place of reliable data and a more precautionary approach.
On biotechnology research and conflicts of interest:
As described earlier, there is a marked tendency for bias and conflicts of interest to follow from corporate sources of research funding. In chapter 4 we examined the twin issues of conflicts of interest and bias in the case of research into new therapies and the testing of potentially new pharmaceuticals that had been funded by pharmaceutical companies.
Biases such as these not only compromise the validity of research results, but also adversely impact on the quality of, and public confidence in, science and technology. As we discussed earlier it is essential that any possible or actual conflicts of interest and the potential for bias should be disclosed in order to enable peer reviewers of journal papers, editors and readers to be able to judge for themselves the nature of the findings and the reliability of data and conclusions.
In new and emerging areas like those found in biotechnology, bias is also likely to arise in the form of exaggerated claims made about the new approaches or products. Such bias is difficult to control or account for in the early stages of development of new technologies. The claims made of synthetic biology clearly show that a great deal is expected of the discipline. A recent BBSRC report looked at the social and ethical challenges presented by synthetic biology. The authors, independent researchers with knowledge of the impact of new technologies, warned that one area of biotechnology in particular synthetic biology “must not be over-hyped by its supporters and critics should not exaggerate the risks it poses”.
The issue of the failure to declare potential conflicts of interest is illustrated by a study of 79 papers in molecular biology (including areas in biotechnology) submitted to the journal Nature in a six-month period in 2005. This study shows that, in two-thirds of the papers in which authors had patent applications or company affiliations which might be considered to present competing financial interests, the authors did not disclose them. Only four papers in the study actually declared that some of the authors had competing financial interests. This is despite the International Committee of Medical Journal Editors stating that interests must be declared “whether or not the individual believes that the relationship affects his or her scientific judgment”. The impact of such conflicts of interest, including financial ones, is highly likely to introduce 'publication bias' (a form of sponsorship bias) into data presentation and so pose questions about the reliability of journal reports .... Clearly in areas where funders are powerful and the stakes are high, journal editors must enforce the disclosure of financial interests far more rigorously than is presently the case.
... In summary, commercial influence on biotechnology R&D is considerable, contributing to a strong focus on genetic technologies and a lack of adequate consideration of alternative approaches in fields such as agriculture and medicine. This is in an area that abounds with complex, ethical issues, and is characterised by a great deal of scientific uncertainty. The evidence we have presented demonstrates how commercial pressures can marginalise the proper consideration of wider concerns, with industry-supported lobby groups exerting strong influence over the debate, especially in the policy realm.
On the Berkeley/Syngenta deal:
Conflicts of interest, aside from publication bias, which involve corporate collaboration in the biosciences, have been discussed in the professional press. The University of California (Berkeley) began a five year partnership in 2003 with Syngenta (the Swiss biotechnology firm formerly part of Novartis) which provided $25 million to the university’s plant research effort. Although the deal brought research income to the university it also raised a number of ethical worries, not least about the propriety of the arrangement and the question of intellectual property rights. In 2004 an independent analysis of the collaboration, undertaken by Lawrence Busch, was begun because of widespread unease in the University’s Department of Plant and Microbial Sciences which received the Syngenta funds. The view of the resultant Busch report in 2004 was that the partnership arrangement with Syngenta “compromised the mission of the university” and created serious conflicts of interest. Out of the 20 patents which arose as a consequence of the collaboration, Syngenta followed only six and no licence agreements had been negotiated with the University of California. This example demonstrates how patents can be taken out (thus restricting academic research) even when there is little potential for commercial benefit.
On medical biotech and xenotransplantation:
Work in xenotransplantation was initially held back due to fears of pig viruses being inadvertently imported into the transplant host. The field has seen a revival, however, following the genetic manipulation of pigs to overcome such risks of infection. The early corporate players included Imutran, owned by the pharmaceutical company Novartis. Now companies in the USA like Revivicor are producing GM pigs to supply tissues and perhaps whole organs for transplant into humans. Even if GM pig organs are accepted in human patients, donors face not only the suppression of their immune systems for life but also, potentially, the need to take other drugs to stop unwanted blood clotting and other symptoms of rejection.
The momentum behind the creation of animal models and xenotransplant organ ‘donors’ owe a great deal to corporate pressure, since undertaking and commercialising such research is of great potential interest to them if they hold the gene patents. In fact, the technique relies on simplified views of gene function in health and disease. Focusing on this type of high-tech approach pushes funding for research that supports preventative health care to the margins. A further consideration is whether the problems that xenotransplantation seeks to address would be better tackled through changes to the donor system for human organs.
On the dangers of synthetic biology:
Although synthetic biology is still a relatively new discipline it is highly likely to involve an increasing level of corporate interest in the UK, as is already the case in the USA. Companies like BP, Shell, Chevron and DuPont are currently heavily investing in synthetic biology in the USA. Although presently the UK situation is less well developed than in the US, several UK Research Councils have begun a number of collaborative programmes to enhance the UK synthetic biology research base.
... several professional bodies in the UK and USA including the Royal Society and US National Science Advisory Board for Biosecurity have warned of some potential negative effects of developments in synthetic biology. Some of their concerns echo our own. For instance, the costs and technical barriers impeding gene manipulation and the building of artificial life forms are being rapidly removed. The ETC Group estimates that the price of synthetic DNA has fallen to a tenth of 2000 prices. Such cost reductions are likely to continue. Laboratory costs for undertaking synthetic biology are also low and falling. Similarly the skills needed to undertake such research are to be commonly found at the undergraduate level. The implications for biosecurity (possible weaponisation and similar threats see section 8.4.4 below) and biosafety (accidental release) are of considerable concern and could directly follow from manipulations of the genes of various organisms to make them into bioweapons. For instance the synthesis of a virus or bacteria is highly feasible in the very near future using existing synthetic biology methods, steps having already been made by US-based research groups.
There are at present more than 70 commercial firms which offer gene-synthesising and building short genome segments (DNA libraries). Such developments have the potential to pose serious environmental and security problems...
A number of US government agencies, including the Departments of Defense and Energy, the National Institutes of Health, and the National Science Foundation (NSF), have invested of millions of dollars in synthetic biology centres and research projects. Venture capital companies have also been providing funds for synthetic biology projects. The published NSF research priorities for 2009 indicate synthetic biology funding may increase. Foundations with a science portfolio such as the Bill and Melinda Gates Foundation are investing in synthetic biology projects. Establishments like the Whitehead Laboratory and the University of California at Berkeley have been recipients of such funding. This will very likely drive science to address predominantly economic objectives rather than those of a broader importance and scope.
The situation is more difficult to assess in the UK, but a study by the Royal Academy of Engineering and the Academy of Medical Sciences (its main brief being systems biology as well as synthetic) suggested in 2007
that the establishment of new specialist centres be made a priority. They also added that further investment in the area is urgently required, together with the fostering of interdisciplinary skills and supportive research environments for systems and synthetic biology.
The BBSRC in the UK has already set up seven systems biology centres and, together with the EPSRC and other research councils, plans to devote monies to develop the infrastructure for synthetic biology to thrive. At present Imperial College London, and the Universities of Cambridge, Edinburgh, Glasgow and Manchester have large research groups in synthetic biology. The drive to develop synthetic biology is thus well underway and, given the economic focus that all the Research Councils are supposed to champion in the universities, there will be significant commercial programmes with corporate partners participating in all these developments. As has been seen elsewhere in this report there is little evidence of plans for public or non-partisan oversight. This is despite the advice of an independent BBSRC Report and the joint Royal Society/Royal Academy of Engineering Report on Nanotechnology, which stressed the need for both public engagement and oversight in such new technologies.
The BBSRC allocates around £19 million a year to research activities in synthetic biology whilst the Economic and Social Research Council (ESRC) is funding a Genomics Network to the tune of a modest £12 million, designed to better facilitate both expert and lay discussions of the social, economic, ethical and practical issues which are raised by advances in gene technologies including those to be found in synthetic biology.
What is missing, however, is some substantial objective input to the decision-making process in order to balance the power of the economic agenda (apparent within both corporate and public funding) that is present within synthetic biology - both in the UK and the USA. An independent and influential over view that gathered views from the public as well as expert opinion would help to monitor the pace of development in this powerful field.
On 'garage biotech', biosecurity and biotechnology:
The Royal Society convened an international workshop in 2006 which brought together 84 leading researchers and policy experts to discuss the Biological and Toxins Weapons Convention (BTWC) and various developments in science and technology, including in synthetic biology. The workshop warned that there were significant security problems associated with synthetic biology advances not least the cheapness of DNA technology which could lead to ‘garage biology’, with the consequent risk of bioweapons development... The workshop participants stressed the need for well-constructed regulatory mechanisms, which did not hinder legitimate research. However, they did not comment on the fact that the corporate sector is a powerful and largely unaccountable driver of the growth of this area of research. It is clear that commercial influences were an important aspect in the failure of negotiations on the BTWC verification protocol in 2001: these collapsed under industry pressure that commercial confidentiality arrangements should not be compromised...
Powerful new technologies that may use infective organisms in their research have the potential for 'dual use', i.e. although not intentionally related to military use, the research has the potential to create bioweapons. A number of areas in biotechnology possess the risk, albeit at present quite remote, of abrogating the BTWC. These include:
* Increasing the virulence of existing pathogens or novel agents by changes to the gene(s);
* Changing existing non-pathogenic (harmless) organisms to enable them to cause infections and attack humans and other animals by means of genetic modification;
* Modification of infective agents to avoid human immune mechanisms and thus increase their ability to kill or cause harm;
* Genomic targeting - the use of techniques from gene therapy to target bioweapons to distinct ethnic groups.
Whilst some of these techniques are still in their infancy, the rate of development in biotechnology presents a possible future risk of biosecurity lapses. This is made more likely given the negative aspects - such as secrecy and lack of transparency - that stem from corporate funding and involvement in biotechnology research and governance.