Richard Smith, former editor of the British Medical Journal, has jested that instead of scientific peer review, its rival The Lancet had a system of throwing a pile of papers down the stairs and publishing those that reached the bottom. On another occasion, Smith was challenged to publish an issue of the BMJ exclusively comprising papers that had failed peer review and see if anybody noticed. He replied, “How do you know I haven’t already done it?”
As Smith’s stories show, journal editors have a lot of power in science – power that provides opportunities for abuse. The life science industry knows this, and has increasingly moved to influence and control science publishing.
The strategy, often with the willing cooperation of publishers, is effective and sometimes blatant. In 2009, the scientific publishing giant Elsevier was found to have invented an entire medical journal, complete with editorial board, in order to publish papers promoting the products of the pharmaceutical manufacturer Merck. Merck provided the papers, Elsevier published them, and doctors read them, unaware that the Australasian Journal of Bone and Joint Medicine was simply a stuffed dummy.
Fast forward to September 2012, when the scientific journal Food and Chemical Toxicology (FCT) published a study that caused an international storm (Séralini, et al. 2012). The study, led by Prof Gilles-Eric Séralini of the University of Caen, France, suggested a Monsanto genetically modified (GM) maize, and the Roundup herbicide it is grown with, pose serious health risks. The two-year feeding study found that rats fed both suffered severe organ damage and increased rates of tumors and premature death. Both the herbicide (Roundup) and the GM maize are Monsanto products. Corinne Lepage, France’s former environment minister, called the study “a bomb”.
Subsequently, an orchestrated campaign was launched to discredit the study in the media and persuade the journal to retract it. Many of those who wrote letters to FCT (which is published by Elsevier) had conflicts of interest with the GM industry and its lobby groups, though these were not publicly disclosed.
The journal did not retract the study. But just a few months later, in early 2013 the FCT editorial board acquired a new “Associate Editor for biotechnology”, Richard E. Goodman. This was a new position, seemingly established especially for Goodman in the wake of the “Séralini affair”.
RICHARD E GOODMAN, UNIVERSITY OF NEBRASKA
Richard E. Goodman is professor at the Food Allergy Research and Resource Program, University of Nebraska. But he is also a former Monsanto employee, who worked for the company between 1997 and 2004. While at Monsanto he assessed the allergenicity of the company’s GM crops and published papers on its behalf on allergenicity and safety issues relating to GM food (Goodman and Leach 2004).
Goodman had no documented connection to the journal until February 2013. His fast-tracked appointment, directly onto the upper editorial board raises urgent questions. Does Monsanto now effectively decide which papers on biotechnology are published in FCT? And is this part of an attempt by Monsanto and the life science industry to seize control of science?
To equate one journal with “science” may seem like an exaggeration. But peer-reviewed publication, in the minds of most scientists, is science. Once a paper is published in an academic journal it enters the canon and stands with the discovery of plate tectonics or the structure of DNA. All other research, no matter how groundbreaking or true, is irrelevant. As a scientist once scathingly said of the “commercially confidential” industry safety data that underpin approvals of chemicals and GM foods, “If it isn’t published, it doesn’t exist.”
Goodman’s ILSI links
The industry affiliations of FCT’s new gatekeeper for biotechnology are not restricted to having worked directly for Monsanto. Goodman has an active and ongoing involvement with the International Life Sciences Institute (ILSI). ILSI is funded by the multinational GM and agrochemical companies, including Monsanto. It develops industry-friendly risk assessment methods for GM foods and chemical food contaminants and inserts them into government regulations.
ILSI describes itself as a public interest non-profit but its infiltration of regulatory agencies and influence on risk assessment policy has become highly controversial in North America and Europe. In 2005 US-based non-profits and trade unions wrote to the World Health Organization (WHO) protesting against ILSI’s influence on international health standards protecting food and water supplies. As a result, the WHO barred ILSI from taking part in WHO activities setting safety standards, because of its funding sources. And in Europe in 2012, Diana Banati, then head of the management board at the European Food Safety Authority (EFSA), had to resign over her undisclosed long-standing involvement with ILSI (Robinson et al. 2013).
Goodman’s appointment to FCT is surprising also for the fact that the journal already has expertise in GM food safety. Of the four senior editors, José L. Domingo is a professor of toxicology and environmental health and author of two comprehensive reviews of GM food safety studies (Domingo 2007; Domingo and Bordonaba 2011). Both reviews expressed skepticism of the thesis that GMOs are safe. Consequently, it is far from clear why FCT needs an “associate editor for biotechnology”, but it is clear why Monsanto would have an interest in ensuring that the “Séralini affair” is never repeated.
Editing the scientific record: The case of Paul Christou
FCT is not the only academic journal that appears to have been captured by commercial interests. After the initial campaign failed to get FCT to retract the Séralini study, the journal Transgenic Research published a heavy-handed critique of the study and of the researchers themselves (Arjo et al., 2013). The lead author of that critique was Paul Christou.
Christou and co-authors castigated the editor of FCT for publishing the study, calling it “a clear and egregious breach of the standards of scientific publishing”. They insisted that the journal editor retract the study “based on its clearly flawed data, its breaches of ethical standards, and the strong evidence for scientific misconduct and abuse of the peer-review process”. “Even a full retraction of the Séralini article” wrote Christou, “will not cleanse the Internet of the inflammatory images of tumorous rats.”
The same writers further implied that the Séralini study was “fraudulent”, that the researchers failed to analyse the data objectively, and that the treatment of the experimental animals was inhumane.
This is not the first time Christou has attacked scientific findings that have raised doubts about GM crops. In 2001 Ignacio Chapela and David Quist of the University of California, Berkeley, reported in the journal Nature that indigenous Mexican maize varieties had become contaminated with GM genes (Quist and Chapela, 2001). This issue was, and remains, highly controversial since Mexico is the genetic centre of origin for maize. In an exact parallel with the Séralini study, an internet campaign was waged against Chapela and Quist demanding that the journal retract the study. Then Christou, just as he was later to do with the Séralini study, attacked Chapela and Quist’s paper in an article in Transgenic Research. The title said it all: “No credible scientific evidence is presented to support claims that transgenic DNA was introgressed into traditional maize landraces in Oaxaca, Mexico” (Christou, 2002).
Responding to the campaign, Nature editor Philip Campbell asked Chapela and Quist for more data, which they provided, and arranged another round of peer review. Only one reviewer in the final group of three supported retraction, and no one had presented any data or analysis that contradicted Chapela and Quist’s main finding. Nevertheless, Nature asserted, “The evidence available is not sufficient to justify the publication of the original paper”. Some subsequent investigations, testing different samples, reported finding GM genes in native landraces of Mexican corn (Pineyro-Nelson et al. 2009), while others did not (Ortiz-Garcia et al. 2005).
Paul Christou, in contrast, probably did not have much trouble getting either of his critiques published in Transgenic Research. He is the journal’s editor-in-chief. And, like Goodman, Christou is connected to Monsanto. Monsanto bought the GM seed company Agracetus (Christou’s former employer) and Monsanto now holds patents for the production of GM crops on which Christou is named as the inventor. It is normal practice to declare inventor status on patents as a competing interest in scientific articles, but Christou did not disclose either conflict of interest – his editorship of the journal or his patent inventor status – in his critique of the Séralini study.
The Ermakova affair: Preemptive editing of the scientific record
Not only can journal editors prevent the publication of research showing problems with GM crops in their own journals – they can effectively prevent publication elsewhere. In 2007, the leading academic journal Nature Biotechnology featured an extraordinary attack on the work of Russian scientist, Irina Ermakova (Marshall, 2007). Her laboratory research had found decreased weight gain, increased mortality, and decreased fertility in rats fed GM Roundup-tolerant soy over several generations (Ermakova, 2006; Ermakova, 2009).
The editor of Nature Biotechnology, Andrew Marshall, contacted Ermakova, inviting her to answer questions about her findings, which she had only presented at conferences. He told her it was “an opportunity to present your own findings and conclusions in your own words, rather than a critique from one side”. Ermakova agreed.
The process that followed was as deceptive as it was irregular. The editor sent Ermakova a set of questions about her research, which she answered. In due course she was sent a proof of what she thought was to be ‘her’ article, with her byline as author.
However, the article that was finally published was very different. Ermakova’s byline had been removed and Marshall’s substituted. Each of Ermakova’s answers to the questions was followed by a lengthy critique by four pro-GM scientists (Marshall, 2007). The proof sent to Ermakova, now revealed as a ‘dummy proof’, had not included these critical comments. Consequently, she was denied the chance to address them in the same issue of the journal. And in the final article the editor had preserved the critics’ references but removed many of Ermakova’s, with the effect that her statements appeared unsubstantiated.
Nature Biotechnology’s treatment of Ermakova attracted condemnation from many scientists. It was also strongly criticized in some media outlets. Harvey Marcovitch, former editor of a scientific journal and now director of the Committee on Publication Ethics (COPE), which sets ethical standards for academic journals, commented, “This is a type of publication which I have never encountered.” He said that while reading it he was struck by “some surprising things”. He was unwilling to speculate as to what exactly happened: “Either the editor was trying out a new form of experimentation, in which not everything went according to plan, or there was indeed a conspiracy or whatever one wants to call it.”
Dr Brian John of the Wales-based campaign group GM-Free Cymru was more blunt, calling the process “tabloid academic publishing involving deception, lies, duplicity and editorial malpractice”.
Amid the uproar, editor Marshall released his email correspondence with Ermakova on the internet. It showed that far from his having “solicited” the comments from the critics, as he had originally claimed, the four pro-GM scientists had themselves approached the journal proposing their “critique”, and even though none of them are toxicologists, Marshall had agreed. The self-selected critics judged Ermakova’s research – which they had never even seen in its complete form – “demonstrably flawed”.
Nature Biotechnology also failed to fully disclose the conflicts of interest of Ermakova’s critics. Bruce Chassy was lead author on two influential ILSI publications, which defined weak risk assessment methodologies for GM crops that were later inserted into the guidelines of the European Food Safety Authority (EFSA). Vivian Moses was chairman of CropGen, a GM industry lobby group with Monsanto among its funders. L. Val Giddings, an industry consultant, was described in the article as formerly of the Biotechnology Industry Organization (BIO). Nature Biotechnology omitted to say that Giddings occupied a senior position at BIO – vice president for food and agriculture – and that BIO’s funders include the GM crop companies, Monsanto, Dow and DuPont. The last of the four critics, Alan McHughen, developed a GM flax called Triffid that in 2009 was found to have contaminated flax supplies coming into Europe from Canada. If these interests had been disclosed, readers might have judged the criticism of Ermakova differently.
Open source scientific publishing?
These examples show that the threat to scientific publishing from industry influence is real. The avenues for researchers to publish critical views in science are already few. This is especially true for the high-impact journals that the media notices and that therefore influence public discourse. Equally problematic is that few scientific institutions will support researchers whose findings contradict industry viewpoints, as Chapela found out when UC Berkeley tried to deny him tenure following the controversial maize study. Even fewer funding sources will give to such researchers. Consequently almost all funding of biosafety research finds its way into the hands of researchers with industry ties.
This directly affects the quality of the science produced. A recent literature review found that most studies concluding that GM foods are as safe as non-GM counterparts were performed by the developer companies or their associates (Domingo and Bordonaba, 2011). . It is no coincidence that Norway, a country without an agricultural industry lobby, hosts the only publicly funded institute in the world with a mission to conduct research on the environmental, health and social consequences of genetic engineering.
There are in principle ways within the existing system to mitigate or neutralize the influence of industry on the ability of scientists to publish independent and critical research. The first is transparency in publishing. Journal editors should adopt the COPE guidelines and publish all conflicts of interest among staff and editors.
Also in line with COPE’s stipulation, peer reviewers should be selected to avoid conflicts of interest. If this proves impossible due to the spread of patents and industry research funding, then care must be taken to select a balanced panel representing a plurality of views. FCT is a member of COPE, but does not publish information on editors’ conflicts of interest, and its appointment of Goodman over Domingo shows that it does not seek to avoid them.
There may in fact be a need to critically examine the entire concept of peer review. The limitations of all types of expert opinion – whether that of an individual expert or of an expert panel – are recognized in the field of evidence-based medicine. To address this problem, bodies such as the non-profit Cochrane Collaboration have developed systematic and transparent methodologies to review and evaluate data on the effectiveness of different medical interventions. The aim is to enable healthcare practitioners to make well-informed clinical decisions. The reviewing criteria are transparently set out in advance, so there is less scope for bias in evaluations of studies. When disagreements do occur, it is easy to pinpoint the reason and resolve the problem. Cochrane also implements rules to prevent conflicts of interest among its reviewers and editorial board.
The Cochrane approach is widely respected and the lessons learned in evidence-based medicine about conflicts of interest and resisting industry pressure are being applied to other fields, such as hazardous environmental exposures (Woodruff et al., 2011). There is no reason why scientific journals, including those publishing GMO research, cannot use similar methods to evaluate papers, so that less discretion is given to experts with conflicts of interest.
Implementing such policies presumes strong support among the scientific community for independent science. But this support may not exist outside of medical research.
FCT took on Goodman, a former Monsanto employee and well-known supporter of industry viewpoints, immediately following the publication of a controversial paper that was critical of Monsanto’s principal products. In doing so, FCT senior management bypassed the normal scientific editorial culture of gradual promotion from within.
Meanwhile, two other prominent academic journals have served as platforms for their editors to generate unsubstantiated and unscientific abuse without any repercussions for their editorial positions. Marshall remains editor of Nature Biotechnology. The fact that journal editors get away with such behavior suggests that support for independent research among scientists is generally lacking and that accountability within the scientific publishing world barely exists.
It seems unlikely that scientific journals will address unaided the defects in scientific publishing at FCT and elsewhere. To do so would require confronting the fundamental problem that academic science now largely makes its money from exploiting conflicts of interest. This has become the underlying business model of science. Universities offer ‘independent’ advice to governments while taking corporate money for ‘research’. Corporations offer that money to universities, not for the knowledge it generates, but primarily for the influence it buys.
These same incentives are reinforced at the personal level as well. Individual scientists occupy taxpayer-funded academic positions while benefitting from patents, stocks and industry consultancies. If journals and government agencies took action to eliminate conflicts of interest, the corporate money for science would dry up, because industry-funded scientists would lose influence.
But if scientific journals do not find a way to level the playing field for critical studies, the few scientists who are still able to carry out independent public interest research may need to find an alternative publishing model: public peer review, or ‘open-source science’. Such online collaborative approaches could even revitalize scientific publishing.
Unless radical reform is achieved, peer-reviewed publication, which many hold to be the defining characteristic of science, will have undergone a remarkable inversion. From its origin as a safeguard of quality and independence, it will have become a tool through which one vision, that of corporate science, came to assert ultimate control. Richard Goodman, FCT’s new Associate Editor for biotechnology, now has the opportunity to throw down the stairs only those papers marked “industry approved”.
How should a regulatory agency announce they have discovered something potentially very important about the safety of products they have been approving for over twenty years?
In the course of analysis to identify potential allergens in GMO crops, the European Food Safety Authority (EFSA) has belatedly discovered that the most common genetic regulatory sequence in commercial GMOs also encodes a significant fragment of a viral gene (Podevin and du Jardin 2012). This finding has serious ramifications for crop biotechnology and its regulation, but possibly even greater ones for consumers and farmers. This is because there are clear indications that this viral gene (called Gene VI) might not be safe for human consumption. It also may disturb the normal functioning of crops, including their natural pest resistance.
What Podevin and du Jardin discovered is that of the 86 different transgenic events (unique insertions of foreign DNA) commercialized to-date in the United States 54 contain portions of Gene VI within them. They include any with a widely used gene regulatory sequence called the CaMV 35S promoter (from the cauliflower mosaic virus; CaMV). Among the affected transgenic events are some of the most widely grown GMOs, including Roundup Ready soybeans (40-3-2) and MON810 maize. They include the controversial NK603 maize recently reported as causing tumors in rats (Seralini et al. 2012).
The researchers themselves concluded that the presence of segments of Gene VI “might result in unintended phenotypic changes”. They reached this conclusion because similar fragments of Gene VI have already been shown to be active on their own (e.g. De Tapia et al. 1993). In other words, the EFSA researchers were unable to rule out a hazard to public health or the environment.
In general, viral genes expressed in plants raise both agronomic and human health concerns (reviewed in Latham and Wilson 2008). This is because many viral genes function to disable their host in order to facilitate pathogen invasion. Often, this is achieved by incapacitating specific anti-pathogen defenses. Incorporating such genes could clearly lead to undesirable and unexpected outcomes in agriculture. Furthermore, viruses that infect plants are often not that different from viruses that infect humans. For example, sometimes the genes of human and plant viruses are interchangeable, while on other occasions inserting plant viral fragments as transgenes has caused the genetically altered plant to become susceptible to an animal virus (Dasgupta et al. 2001). Thus, in various ways, inserting viral genes accidentally into crop plants and the food supply confers a significant potential for harm.
The Choices for Regulators
The original discovery by Podevin and du Jardin (at EFSA) of Gene VI in commercial GMO crops must have presented regulators with sharply divergent procedural alternatives. They could 1) recall all CaMV Gene VI-containing crops (in Europe that would mean revoking importation and planting approvals) or, 2) undertake a retrospective risk assessment of the CaMV promoter and its Gene VI sequences and hope to give it a clean bill of health.
It is easy to see the attraction for EFSA of option two. Recall would be a massive political and financial decision and would also be a huge embarrassment to the regulators themselves. It would leave very few GMO crops on the market and might even mean the end of crop biotechnology.
Regulators, in principle at least, also have a third option to gauge the seriousness of any potential GMO hazard. GMO monitoring, which is required by EU regulations, ought to allow them to find out if deaths, illnesses, or crop failures have been reported by farmers or health officials and can be correlated with the Gene VI sequence. Unfortunately, this particular avenue of enquiry is a scientific dead end. Not one country has carried through on promises to officially and scientifically monitor any hazardous consequences of GMOs (1).
Unsurprisingly, EFSA chose option two. However, their investigation resulted only in the vague and unreassuring conclusion that Gene VI “might result in unintended phenotypic changes” (Podevin and du Jardin 2012). This means literally, that changes of an unknown number, nature, or magnitude may (or may not) occur. It falls well short of the solid scientific reassurance of public safety needed to explain why EFSA has not ordered a recall.
Can the presence of a fragment of virus DNA really be that significant? Below is an independent analysis of Gene VI and its known properties and their safety implications. This analysis clearly illustrates the regulators’ dilemma.
The Many Functions of Gene VI
Gene VI, like most plant viral genes, produces a protein that is multifunctional. It has four (so far) known roles in the viral infection cycle. The first is to participate in the assembly of virus particles. There is no current data to suggest this function has any implications for biosafety. The second known function is to suppress anti-pathogen defenses by inhibiting a general cellular system called RNA silencing (Haas et al. 2008). Thirdly, Gene VI has the highly unusual function of transactivating (described below) the long RNA (the 35S RNA) produced by CaMV (Park et al. 2001). Fourthly, unconnected to these other mechanisms, Gene VI has very recently been shown to make plants highly susceptible to a bacterial pathogen (Love et al. 2012). Gene VI does this by interfering with a common anti-pathogen defense mechanism possessed by plants. These latter three functions of Gene VI (and their risk implications) are explained further below:
1) Gene VI Is an Inhibitor of RNA Silencing
GENE VI (UPPER LEFT) PRECEDES THE START OF THE 35S RNA
RNA silencing is a mechanism for the control of gene expression at the level of RNA abundance (Bartel 2004). It is also an important antiviral defense mechanism in both plants and animals, and therefore most viruses have evolved genes (like Gene VI) that disable it (Dunoyer and Voinnet 2006).
GENE VI (UPPER LEFT) PRECEDES THE START OF THE 35S RNA
This attribute of Gene VI raises two obvious biosafety concerns: 1) Gene VI will lead to aberrant gene expression in GMO crop plants, with unknown consequences and, 2) Gene VI will interfere with the ability of plants to defend themselves against viral pathogens. There are numerous experiments showing that, in general, viral proteins that disable gene silencing enhance infection by a wide spectrum of viruses (Latham and Wilson 2008).
2) Gene VI Is a Unique Transactivator of Gene Expression
Multicellular organisms make proteins by a mechanism in which only one protein is produced by each passage of a ribosome along a messenger RNA (mRNA). Once that protein is completed the ribosome dissociates from the mRNA. However, in a CaMV-infected plant cell, or as a transgene, Gene VI intervenes in this process and directs the ribosome to get back on an mRNA (reinitiate) and produce the next protein in line on the mRNA, if there is one. This property of Gene VI enables Cauliflower Mosaic Virus to produce multiple proteins from a single long RNA (the 35S RNA). Importantly, this function of Gene VI (which is called transactivation) is not limited to the 35S RNA. Gene VI seems able to transactivate any cellular mRNA (Futterer and Hohn 1991; Ryabova et al. 2002). There are likely to be thousands of mRNA molecules having a short or long protein coding sequence following the primary one. These secondary coding sequences could be expressed in cells where Gene VI is expressed. The result will presumably be production of numerous random proteins within cells. The biosafety implications of this are difficult to assess. These proteins could be allergens, plant or human toxins, or they could be harmless. Moreover, the answer will differ for each commercial crop species into which Gene VI has been inserted.
3) Gene VI Interferes with Host Defenses
A very recent finding, not known by Podevin and du Jardin, is that Gene VI has a second mechanism by which it interferes with plant anti-pathogen defenses (Love et al. 2012). It is too early to be sure about the mechanistic details, but the result is to make plants carrying Gene VI more susceptible to certain pathogens, and less susceptible to others. Obviously, this could impact farmers, however the discovery of an entirely new function for gene VI while EFSA’s paper was in press, also makes clear that a full appraisal of all the likely effects of Gene VI is not currently achievable.
Is There a Direct Human Toxicity Issue?
When Gene VI is intentionally expressed in transgenic plants, it causes them to become chlorotic (yellow), to have growth deformities, and to have reduced fertility in a dose-dependent manner (Ziljstra et al 1996). Plants expressing Gene VI also show gene expression abnormalities. These results indicate that, not unexpectedly given its known functions, the protein produced by Gene VI is functioning as a toxin and is harmful to plants (Takahashi et al 1989). Since the known targets of Gene VI activity (ribosomes and gene silencing) are also found in human cells, a reasonable concern is that the protein produced by Gene VI might be a human toxin. This is a question that can only be answered by future experiments.
Is Gene VI Protein Produced in GMO Crops?
Given that expression of Gene VI is likely to cause harm, a crucial issue is whether the actual inserted transgene sequences found in commercial GMO crops will produce any functional protein from the fragment of Gene VI present within the CaMV sequence.
There are two aspects to this question. One is the length of Gene VI accidentally introduced by developers. This appears to vary but most of the 54 approved transgenes contain the same 528 base pairs of the CaMV 35S promoter sequence. This corresponds to approximately the final third of Gene VI. Deleted fragments of Gene VI are active when expressed in plant cells and functions of Gene VI are believed to reside in this final third. Therefore, there is clear potential for unintended effects if this fragment is expressed (e.g. De Tapia et al. 1993; Ryabova et al. 2002; Kobayashi and Hohn 2003).
The second aspect of this question is what quantity of Gene VI could be produced in GMO crops? Once again, this can ultimately only be resolved by direct quantitative experiments. Nevertheless, we can theorize that the amount of Gene VI produced will be specific to each independent insertion event. This is because significant Gene VI expression probably would require specific sequences (such as the presence of a gene promoter and an ATG [a protein start codon]) to precede it and so is likely to be heavily dependent on variables such as the details of the inserted transgenic DNA and where in the plant genome the transgene inserted.
Commercial transgenic crop varieties can also contain superfluous copies of the transgene, including those that are incomplete or rearranged (Wilson et al 2006). These could be important additional sources of Gene VI protein. The decision of regulators to allow such multiple and complex insertion events was always highly questionable, but the realization that the CaMV 35S promoter contains Gene VI sequences provides yet another reason to believe that complex insertion events increase the likelihood of a biosafety problem.
Even direct quantitative measurements of Gene VI protein in individual crop authorizations would not fully resolve the scientific questions, however. No-one knows, for example, what quantity, location or timing of protein production would be of significance for risk assessment, and so answers necessary to perform science-based risk assessment are unlikely to emerge soon.
Big Lessons for Biotechnology
It is perhaps the most basic assumption in all of risk assessment that the developer of a new product provides regulators with accurate information about what is being assessed. Perhaps the next most basic assumption is that regulators independently verify this information. We now know, however, that for over twenty years neither of those simple expectations have been met. Major public universities, biotech multinationals, and government regulators everywhere, seemingly did not appreciate the relatively simple possibility that the DNA constructs they were responsible for encoded a viral gene.
This lapse occurred despite the fact that Gene VI was not truly hidden; the relevant information on the existence of Gene VI has been freely available in the scientific literature since well before the first biotech approval (Franck et al 1980). We ourselves have offered specific warnings that viral sequences could contain unsuspected genes (Latham and Wilson 2008). The inability of risk assessment processes to incorporate longstanding and repeated scientific findings is every bit as worrysome as the failure to intellectually anticipate the possibility of overlapping genes when manipulating viral sequences.
This sense of a generic failure is reinforced by the fact that this is not an isolated event. There exist other examples of commercially approved viral sequences having overlapping genes that were never subjected to risk assessment. These include numerous commercial GMOs containing promoter regions of the closely related virus figwort mosaic virus (FMV) which were not considered by Podevin and du Jardin. Inspection of commercial sequence data shows that the commonly used FMV promoter overlaps its own Gene VI (Richins et al 1987). A third example is the virus-resistant potato NewLeaf Plus (RBMT-22-82). This transgene contains approximately 90% of the P0 gene of potato leaf roll virus. The known function of this gene, whose existence was discovered only after US approval, is to inhibit the anti-pathogen defenses of its host (Pfeffer et al 2002). Fortunately, this potato variety was never actively marketed.
A further key point relates to the biotech industry and their campaign to secure public approval and a permissive regulatory environment. This has led them to repeatedly claim, firstly, that GMO technology is precise and predictable; and secondly, that their own competence and self-interest would prevent them from ever bringing potentially harmful products to the market; and thirdly, to assert that only well studied and fully understood transgenes are commercialized. It is hard to imagine a finding more damaging to these claims than the revelations surrounding Gene VI.
Biotechnology, it is often forgotten, is not just a technology. It is an experiment in the proposition that human institutions can perform adequate risk assessments on novel living organisms. Rather than treat that question as primarily a daunting scientific one, we should for now consider that the primary obstacle will be overcoming the much more mundane trap of human complacency and incompetence. We are not there yet, and therefore this incident will serve to reinforce the demands for GMO labeling in places where it is absent.
What Regulators Should Do Now
This summary of the scientific risk issues shows that a segment of a poorly characterized viral gene never subjected to any risk assessment (until now) was allowed onto the market. This gene is currently present in commercial crops and growing on a large scale. It is also widespread in the food supply.
Even now that EFSA’s own researchers have belatedly considered the risk issues, no one can say whether the public has been harmed, though harm appears a clear scientific possibility. Considered from the perspective of professional and scientific risk assessment, this situation represents a complete and catastrophic system failure.
But the saga of Gene VI is not yet over. There is no certainty that further scientific analysis will resolve the remaining uncertainties, or provide reassurance. Future research may in fact increase the level of concern or uncertainty, and this is a possibility that regulators should weigh heavily in their deliberations.
To return to the original choices before EFSA, these were either to recall all CaMV 35S promoter-containing GMOs, or to perform a retrospective risk assessment. This retrospective risk assessment has now been carried out and the data clearly indicate a potential for significant harm. The only course of action consistent with protecting the public and respecting the science is for EFSA, and other jurisdictions, to order a total recall. This recall should also include GMOs containing the FMV promoter and its own overlapping Gene VI.
1) EFSA regulators might now be regretting their failure to implement meaningful GMO monitoring. It would be a good question for European politicians to ask EFSA and for the board of EFSA to ask the GMO panel, whose job it is to implement monitoring.
A restriction on the use of three pesticides belonging to the neonicotinoid family was today adopted by the Commission. These pesticides (clothianidin, imidacloprid and thiametoxam) were identified as being harmful to Europe’s honeybee population. This restriction will enter into force as from 1 December 2013 and will be reviewed, at the latest, within two years. It targets pesticides used in the treatment of plants and cereals that are attractive to bees and pollinators.
“Last month, I pledged that, based on the number of risks identified by the European Food Safety Authority’s scientific opinion, I would do my utmost to ensure that our honeybee population is protected. Today’s adoption delivers on that pledge and marks another milestone towards ensuring a healthier future for our honeybees, as bees have two important roles to play: not only that of producing honey but primarily to be a pollinator. About 80 % of all pollination is due to the activity of bees – this is natural and free of costs” said Tonio Borg, Commissioner for Health and Consumer Policy.
Today’s measure forms part of the Commission’s overall strategy1 to tackle the decline of Europe’s bee population. Since the publication of the Commission’s bee health strategy in 2010, several actions have been taken or are underway. These include: the designation of a EU Reference Laboratory for bee health; increased EU co-financing for national apiculture programmes, co-financing to carry out surveillance studies in 17 voluntary Member States (€3.3 million were allocated in 2012) and EU research programmes such as BeeDoc and STEP which look into the multifactorial aspects that could be attributed to Europe’s bee decline.
Member States must withdraw or amend existing authorisations to comply with the EU restrictions by 30 September 2013. They can allow the use of existing stocks until 30 November at the latest. National authorities are responsible for ensuring that the restrictions are correctly applied.
As soon as new information is available, and at the latest within 2 years, the Commission will review this restriction to take into account relevant scientific and technical developments.
Following the absence of an agreement (qualified majority) between Member States during the appeal committee of 29 April 2013, the Commission announced that it will proceed with the restriction as foreseen.
The restriction applies to the use of 3 neonicotinoids (clothianidin, imidacloprid and thiametoxam) for seed treatment, soil application (granules) and foliar treatment on plants and cereals (with the exception of winter cereals) that are attractive to bees. The remaining authorised uses are available only to professionals. Exceptions will be limited to the possibility to treat bee-attractive crops in greenhouses, in open-air fields only after flowering.
Pesticides have been identified as one of several factors which may be responsible for the decline in number of bees. Other factors also include parasites, other pathogens, lack of veterinary medicines or sometimes their misuse, apiculture management and environmental factors such as lack of habitat and feed and climate change.
For more information:
The crisis of dramatic bee population decline has been a top issue in media and political debate in Europe. A wide variety of culprits are under scrutiny, including certain parasites, viruses, pesticides and industrial agriculture. But new scientific evidence from British and French research institutions, published in Science in early 2012, suggests that neonicotinoids pesticides in particular might be one of the main drivers. Syngenta and Bayer, two companies producing these substances, are waging an all-out lobbying war against the proposed partial ban of these substances by the European Commission following EFSA’s (European Food Safetey Authority) opinion warning of the risk they pose to bees. Will the pesticide lobby succeed in convincing Member States to vote no to a ban?
New scientific evidence triggers EU concern
Neonicotinoids are a class of insecticides that came onto the market in the mid 1990s and early 2000s. Many crops such as corn, soy, wheat or rapeseed are now treated with them. They are normally applied directly to seeds or in soil treatments, in an attempt to preserve seeds and plants from insect attacks at an early stage. As systemic pesticides, once in the seed, they enter the whole plant through its vascular system and are found in every plant tissue (leaves, flowers, pollen…); but they can also remain active in the soil for a long time (up to three years). Particularly controversial among the neonicotinoids are Thiametoxam, Imidacloprid and Clothianidin, substances patented by biotech and pesticide companies Syngenta and Bayer.
The French scientific study reported the loss of honeybee foragers caused by exposure to low doses of Thiamethoxam (Syngenta). The British study reported that low doses of Imidacloprid (Bayer) affected the colonies of bumblebees, reducing their development and their reproduction, including a dramatic loss of queens. Authors stated that, “given the scale of use of neonicotinoids, we suggest that they may be having a considerable negative impact on wild bumble bee populations across the developed world.”
In March 2012 the European Commission mandated the European Food Safety Authority (EFSA) to deliver a scientific opinion on a report that led Italy to temporarily suspend the placing on the market of maize seeds treated with neonicotinoids. In April 2012 the Commission broadened its request to include the new scientific evidence published in Science. In addition to Italy, Slovenia and Germany had already applied protective measures, including temporary suspensions or bans in certain uses of neonicotinoids.
A furious lobbying campaign
In June 2012, the French Government announced its intention to withdraw the registration of Thiamethoxam. The pesticides industry immediately started putting pressure on the Commission. This was the beginning of a furious lobbying campaign; a series of letters sent by Syngenta, Bayer and the European Crop Protection Association (ECPA, the pesticides producers’ lobby whose members include Bayer, Monsanto, BASF, Dow, and DuPont / Syngenta) to the European Commission and EFSA, seen by CEO, have enabled us to reconstruct its story. Here are the main arguments used by these two companies:
- It’s farmers’ fault. Bayer, in a letter addressed to Commissioner Dalli, claims that past incidents of pesticide poisoning that affected honey bees were the result of inappropriate use and/or lack of precaution in applying the substance, thus they offload responsibility onto farmers rather than the product itself.
- Just a small group of activists and hobby beekeepers. Syngenta made the accusation that some Member States, “driven by a small group of activists and hobby beekeepers” are lobbying to suspend, “their insecticide and all other neonicotinoids. And they urged the Commissioner to “resist this pressure” for the sake of the credibility of the EU’s regulatory process.
- Me and my friend Obama. Syngenta’s CEO, Michael Mack, personally wrote to Commissioner Dalli to remind him that just two weeks before he had lunched at the G-8 summit with US President Obama, President of the European Council Van Rompuy, President of the European Commission Barroso and France’s President Hollande, discussing the contribution of the private sector to global food security and the money Syngenta was committed to spend in Africa.
- Keep calm, and use neonicotinoids. In another letter sent in November to Commissioners Ciolos (Agriculture) and Geoghegan-Quinn (Research) in November, and to all EU Agriculture Ministers, Syngenta called for a comprehensive review, that they insisted was necessary to avoid “wrong conclusions from a rushed process that could have disastrous implications for agriculture and ironically for bee health”. This, added to the fact that it was only three neonicotinoids (including Syngenta’s Thiamethoxam) being singled out, was “desperately disappointing” for Syngenta.
- “Independent” analysis show that Europe can’t survive without neonicotinoids. According to Syngenta, who didn’t provide any references to back up the claim, “the loss of this technology will cost farmers and consumers up to €1 billion and undermine the production of safe and affordable food”. In a letter they sent in November they stated that according to “independent analysis” there would be significant damage to European agriculture if their product was banned (more than €17 bn over the next five years) as well as the risk of relocation of corn production. In addition, ECPA claims potential yield losses of up to 10% in oilseed rape and cereals, 30% in sugarbeet and 50% in maize as a result of a potential ban.Another study promoted by industry was research carried by the Humboldt Forum for Food and Agriculture, that concluded that neonicotinoid pesticides make a significant socio-econonomic and environmental contribution to European agriculture and the wider economy. The support and partners of this Institute include BASF, Bayer CropScience, E.ON, KWS and Nestlé. The study was supported by Copa-Cogeca (the big farmers’ lobby group in Brussels), the European Seeds Association (mainly representing the largest companies in the seed industry) and the European Crop Protection Association, and financed by Bayer and Syngenta. This, however, was not mentioned in Syngenta and Bayer’s letters.
- ‘Science’ is on my side. For decades, industry’s strategy has been to advocate for a science-based policy. But which science exactly? This particular lobbying campaign provides helpful insights into the sort of science industry favours, and the sort it doesn’t.Firstly, a comment can be made about the role of EFSA. Industry usually pushes for decisions to be made by scientists and experts rather than politicians, the latter having to justify themselves in front of voters; it was therefore not a surprise to read the pesticides lobby ECPA write to the Commission that “as an industry, we welcome the fact that EFSA is carrying out a detailed evaluation on the use of these seed treatments”. In the meantime, they lobbied the European Commission with scientific studies backing their commercial interests: Bayer explained to the Commission that neonicotinoids were not responsible for bee decline as other experts maintained that pathogens and parasites were the main problem. Meanwhile, Syngenta questioned the conditions in which the studies with critical findings were performed, claiming that the exposure in these studies significantly exceeded any real situation found in the field. According to them, France was taking decisions in the absence of “any validated science”. The company also delivered to the Commission a costly GLP (Good Laboratory Practice)-compliant study on bees exposed to corn treated with thiamethoxam it had sent to the private analysis lab Eurofins. This study concluded that “no effect in terms of mortality, honeybee activity and brood development and behaviour of the honeybees” could be observed1.
However, EFSA’s opinion,published on 16th January, was not the one the companies had hoped for: it was very critical of the use of these pesticides, although the agency was not able to finalise the assessments in some cases due to shortcomings in the available data (remember: EFSA usually doesn’t do any research and merely assesses others’ work). EFSA and its scientific experts found risks to bees associated with neonicotinoids pesticide exposures from pollen and nectar contaminated with pesticide, from pesticide dust, and from exposure from guttation (plants exudating drops of sap on the tips or edges of their leaves).
Bayer immediately counter-attacked: they commissioned another analysis of EFSA’s conclusion by “an independent panel of bee scientists”: in fact, the company Exponent®, which specialises in defending products from regulation. Exponent® came to the conclusion that “EFSA risk assessments use unrealistic exposure values, make inappropriate comparisons to toxicity threshold levels, fail to consider critical bee behaviour, and inappropriately discount monitoring and field studies”, and therefore “overstates the risks to honey bees”. Exponent®’s modus operandi is reanalysis of scientific studies detrimental to industry to cast doubt on their conclusions in order to prevent their use for regulatory purposes, but their production, tailored for litigation, has been described as “more legal pleadings than scientific papers”.2
- You don’t like my science? You will hear from my lawyers. Syngenta had access to EFSA’s press release before its publication. They immediately sent an extremely aggressive letter to the agency, claiming that the press release was “incorrect in a major and highly relevant aspect but EFSA also moves out of its area of responsibility and mandate”. Syngenta even threatened to take legal action and set a deadline: “we ask you to formally confirm that you will rectify the press release by 11 o’clock. Otherwise you will appreciate that we will consider our legal options.”Syngenta’s anger increased when the press release was published without major changes. In several letters to EFSA they insisted that the press release is “inaccurate and contrary to the EFSA conclusion”. And the company requested access to documents such as all the draft versions of the press release, internal correspondence and the preparatory meeting notes that led to the draft.
After analysing the documents provided by EFSA, they then targeted EFSA’s Director, accusing her of not including Syngenta’s comments on the draft press release in harsh terms: “you took the personal responsibility to overrule the internal EFSA proposal to rectify the incorrect press release”. Therefore, “Syngenta would appreciate further explanations from you” before “deciding on the legal options available to it and the identity of specific defendants in any possible court action”.
Syngenta wanted to find culprits, and therefore requested more documents, including handwritten notes of internal EFSA meetings as well as all the correspondence regarding their attempts to change the draft press release.
- Mr. Politician, please help me against these ignorant scientists. Threatening EFSA having proved ineffective, Syngenta and Bayer are now putting maximum pressure on the Commission and Member States, and publicly blaming EFSA. Syngenta for instance counterattacked that “EFSA has limited practical knowledge of agriculture” and that if this sort of risk assessment was repeated “it would be impossible to maintain the registration of any existing insecticides or to register any new ones”. According to Syngenta, the methodology used by EFSA to conduct the review was “questionable because it was based on a highly theoretical and extremely conservative scientific opinion”.Beyond direct pressures to politicians, Syngenta launched a fierce campaign in various national media to avoid Members States approving the proposal, claiming for example in the UK media that EFSA had been “nobbled”. The pesticides association ECPA has also been really active, promoting the Humboldt Institute study in the European and national media and scaremongering the public with the prospect of disaster should the proposal be approved.
- I’ll solve the problem myself, no need to regulate. The two companies have launched a charm offensiveto be seen as part of the solution rather than of the problem, and for this are launching an upgrade of Syngenta’s PR sting “Operation Pollinator”. This consists in paying a few farmers so that they grow flowers and other plants beneficial to bees on their farms. But how many farms exactly? No figures have been provided.
The battle for Member States’ vote
The battleground is now at the European Member State level. On 15th March, at the Standing Committee on the Food Chain and Animal Health, the European Commission put to the vote a proposal that would restrict for two years the use of Clothianidin, Imidacloprid and Thiametoxam to crops not attractive to bees and to winter cereals, starting 1st of July (meaning this year’s crops would not be affected). It would also prohibit the sale and use of these pesticides to “amateurs”. This proposal was limited and criticised by farmers group and beekeepers for not being ambitious enough, but still failed to reach a qualified majority. It was supported only by 13 member states (Slovenia, Sweden, Poland, the Netherlands, Luxembourg, France, Spain, Denmark, Cyprus, Belgium, Italy, Latvia and Malta), while nine countries (Slovakia, Romania, Czech Republic, Portugal, Austria, Hungary, Lithuania, Ireland and Greece) rejected the proposal. The UK, Germany, Finland, Bulgaria and Estonia abstained.
The proposal will be retabled by Commissioner Borg at the Appeal Committee in the coming weeks, with a vote likely to occur probably on the 26th of April or the 2nd of May. If Member States again fail to reach a qualified majority supporting the proposal, the Commission would have the power to approve it. Meanwhile, the pesticides industry is lobbying Member States hard to try to reach a qualified majority to reject the proposal outright and thus block the ban. The coming weeks’ battle will be crucial: will industry interests prevail against bees’ survival?
- 1.Thiamethoxam – Monitoring of Potential Effects of the Drilling of Thiamethoxam FS Treated Maize Seeds on Honeybees, Guttation Monitoring of Maize Seedlings under Agronomic Use Conditions and Assessment of the Relevance of Guttation for Honeybees in Alsace (France) – Final Report. 15 November 2012, Eurofins Agroscience Services EcoChem GmbH.
- 2.See “Doubt is their product”, D. Michaels, Oxford University Press, 2008, p.46.
Top 10 most unhealthy, cancer-causing foods – never eat these again!
The statement “everything causes cancer” has become a popular hyperbole, and one that some people use as rhetorical fodder to excuse their own dietary and lifestyle failures, particularly as they pertain to cancer risk. But the truth of the matter is that many common food items have, indeed, been scientifically shown to increase cancer risk, and some of them substantially. Here are 10 of the most unhealthy, cancer-causing foods that you should never eat again:
1) Genetically-modified organisms (GMOs). It goes without saying that GMOs have no legitimate place in any cancer-free diet, especially now that both GMOs and the chemicals used to grow them have been shown to cause rapid tumor growth. But GMOs are everywhere, including in most food derivatives made from conventional corn, soybeans, and canola. However, you can avoid them by sticking with certified organic, certified non-GMO verified, and locally-grown foods that are produced naturally without biotechnology
2) Processed meats. Most processed meat products, including lunch meats, bacon, sausage, and hot dogs, contain chemical preservatives that make them appear fresh and appealing, but that can also cause cancer. Both sodium nitrite and sodium nitrate have been linked to significantly increasing the risk of colon and other forms of cancer, so be sure to choose only uncured meat products made without nitrates, and preferably from grass-fed sources
3) Microwave popcorn. They might be convenient, but those bags of microwave popcorn are lined with chemicals that are linked to causing not only infertility but also liver, testicular, and pancreatic cancers. The U.S. Environmental Protection Agency (EPA) recognizes the perfluorooctanoic acid (PFOA) in microwave popcorn bag linings as “likely” carcinogenic, and several independent studies have linked the chemical to causing tumors. Similarly, the diacetyl chemical used in the popcorn itself is linked to causing both lung damage and cancer
4) Soda pop. Like processed meats, soda pop has been shown to cause cancer as well. Loaded with sugar, food chemicals, and colorings, soda pop acidifies the body and literally feeds cancer cells. Common soda pop chemicals like caramel color and its derivative 4-methylimidazole (4-MI) have also specifically been linked to causing cancer
5) ‘Diet’ foods, beverages. Even worse than conventional sugar-sweetened soda pop, though, is “diet” soda pop and various other diet beverages and foods. A recent scientific review issued by the European Food Safety Authority (EFSA) of more than 20 separate research studies found that aspartame, one of the most common artificial sweeteners, causes a range of illnesses including birth defects and cancer. Sucralose (Splenda), saccharin and various other artificial sweeteners have also been linked to causing cancer
6) Refined ‘white’ flours. Refined flour is a common ingredient in processed foods, but its excess carbohydrate content is a serious cause for concern. A study published in the journal Cancer Epidemiology, Mile Markers, and Prevention found that regular consumption of refined carbohydrates was linked to a 220 percent increase in breast cancer among women. High-glycemic foods in general have also been shown to rapidly raise blood sugar levels in the body, which directly feeds cancer cell growth and spread
7) Refined sugars. The same goes for refined sugars, which tend to rapidly spike insulin levels and feed the growth of cancer cells. Fructose-rich sweeteners like high-fructose corn syrup (HFCS) are particularly offensive, as cancer cells have been shown to quickly and easily metabolize them in order to proliferate. And since cookies, cakes, pies, sodas, juices, sauces, cereals, and many other popular, mostly processed, food items are loaded with HFCS and other refined sugars, this helps explain why cancer rates are on the rise these days
8) Conventional apples, grapes, and other ‘dirty’ fruits. Many people think they are eating healthy when they buy apples, grapes, or strawberries from the store. But unless these fruits are organic or verified to be pesticide-free, they could be a major cancer risk. The Environmental Working Group (EWG) found that up to 98 percent of all conventional produce, and particularly the type found on its “dirty” fruits list, is contaminated with cancer-causing pesticides
9) Farmed salmon. Farmed salmon is another high-risk cancer food, according to Dr. David Carpenter, Director of the Institute for Health and the Environment at the University of Albany. According to his assessment, farmed salmon not only lacks vitamin D, but it is often contaminated with carcinogenic chemicals, PCBs (polychlorinated biphenyls), flame retardants, pesticides, and antibiotics
10) Hydrogenated oils. They are commonly used to preserve processed foods and keep them shelf-stable. But hydrogenated oils alter the structure and flexibility of cell membranes throughout the body, which can lead to a host of debilitating diseases such as cancer. Some manufacturers are phasing out the use of hydrogenated oils and replacing them with palm oil and other safer alternatives, but trans fats are still widely used in processed foods
The United States on Monday criticized “unnecessary” European Union rules against genetically modified US crop imports as it prepares to enter free-trade talks with the EU. The United States on Monday criticized “unnecessary” European Union rules against genetically modified US crop imports as it prepares to enter free-trade talks with the EU.
EU restrictions notably have resulted in delays in the approval of new GM traits “despite positive assessments by the European Food Safety Authority (EFSA),” the US Trade Representative‘s office said in a report on reducing trade sanitary barriers.
The USTR also criticized the EU for imposing “commercially infeasible requirements” on GE content in food products under EU Traceability and Labeling regulations.
“Foreign governments continue to impose discriminatory or otherwise unwarranted measures on US agricultural exports,” Demetrios Marantis, the acting USTR, said in a conference call.
“These barriers not only harm US ranchers and farmers… but they also deprive consumers around the world an access to safe, high-quality US food and agricultural goods,” Marantis said.
The US and the EU are planning to launch negotiations aimed at creating the world’s biggest free-trade area that will cover the politically sensitive question of genetically modified crops.
The USTR pointed to the EU’s “unnecessary and burdensome coexistence requirements to planting of GE crops alongside non-GE crops by certain EU member states.”
A French official, speaking on condition of anonymity last month, said that France did not want the upcoming trade negotiations to cover genetically modified crops.
Tags: European Food Safety Authority, European Union, France, General Electric, General Motors, GM, GM Crops, GM Food, Member state of the European Union, Office of the United States Trade Representative, United States