Two-thirds of the expert group created by EFSA to work on the risks posed by gene drives have financial links with organisations developing this technology
EXCERPT: EFSA has failed to recruit a panel that will be reasonably independent, or that will even reflect the diversity of positions in the debate.
EFSA gene drive working group fails independence test
Corporate Europe Observatory, 28 Jun 2019
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Gene drive, a potentially very powerful but controversial technology, is now undergoing regulatory evaluation by the European Food Safety Authority (EFSA). However, two-thirds of the expert group created by EFSA to work on the risks posed by gene drives have financial links with organisations developing this technology. Two of the experts are for instance receiving funding from the Bill & Melinda Gates Foundation, which is in turn financing lobby work in favour of the technology. According to EFSA’s own weak independence policy, one of the experts shouldn’t even have been recruited.
The result? Obvious and serious conflicts of interest. So why did EFSA recruit such a problematic panel on such a sensitive issue? The agency defended itself saying the appointments are compliant with its independence rules (which is incorrect in one case), which actually demonstrates again that these still contain severe loopholes. After so many years of EFSA’s poor and sometimes non-existent implementation of the European Parliament’s repeated requests to close these loopholes, wouldn’t it be time for the Parliament to step up the pressure a bit?
EFSA created its working group on gene drive following the mandate it received from the European Commission in June 2018. This mandate requested EFSA to “identify potential risks in terms of impact on human and animal health and the environment that gene drive modified organisms could pose”; to “identify potential novel hazards of gene drive modified organisms”; and to “determine whether the existing guidelines for risk assessment are adequate and sufficient for gene drive modified organisms”.
EFSA accepted the mandate in August 2018, created the working group at the end of the year, and promised to deliver its opinion before March 2020. The agency organised a workshop to discuss the issues with various stakeholders in May 2019.
Gene drive is a new, potentially very powerful genetic engineering approach through which scientists force a gene – thanks to genome editing techniques such as Crispr-Cas9 – into the population of a given species so that a desired trait is inherited at a higher rate and with greater certainty than through natural reproduction alone. For the first time ever, this could enable the genetic re-engineering of an entire species in the wild, whether it be to eradicate or radically transform it.
The stakes of gene drive are very high, and so are the risks. So far, the technology has not proven to be reversible or containable, meaning mistakes must be avoided at all costs. As a result, the main current sources of funding for developing the technology are either philanthropy (the Bill & Melinda Gates Foundation) or the military (the US Department of Defense’s DARPA agency). As gene drive can have military uses as well – US Director of National Intelligence James Clapper even listed genome editing as a weapon of mass destruction in February 2016 – the military is also seeking antidotes to it. In December 2017, CEO documented how the Bill & Melinda Gates Foundation was funding lobby work at the UN Convention on Biological Diversity, in coordination with other US and EU lobby groups from the biotech and pesticides industries, to convince regulators worldwide to oppose a moratorium on the technology.
One of the leading companies in the gene drive field is the British firm Oxitec (short for ‘Oxford Insects Technologies’), created in 2002 as a spin-off from the University of Oxford. The company was bought in 2015 for $160 million by the US synthetic biology company Intrexon (whose largest shareholder with more than 40% is Third Security, a US venture capital firm mostly investing in life sciences start-ups).
Oxitec’s projects have already led to real-life experimentation, with the release of millions of GM Aedes aegypti mosquitoes into the wild in Malaysia, Grand Cayman, Brazil and Panama. These mosquitoes can carry multiple diseases, such as dengue fever and the chikungunya and zika viruses. They have been genetically engineered so that their offspring dies before reproducing, thereby reducing the size of the disease-carrying population. While the first releases involved GM mosquitoes without a gene drive, the second generation of Oxitec’s GM mosquitoes – called Friendly™ – includes a genome modification that causes all female offspring to die. Only females feed on humans, but all male offspring survivors inherit the genome modification and cause their own female offspring to die, and so on and so forth.
Oxitec is also developing GM versions of two other mosquitoes that are vectors of dangerous human diseases. Their engineered Asian tiger mosquito Aedes albopictus carries the diseases mentioned above plus yellow fever. It is of particular interest to Europeans these days as Asian tiger mosquitos are spreading over the continent Sidenote. The second creation – with the help of $7 million in funding from the Bill & Melinda Gates Foundation – is a GM version of Anopheles, the mosquito that carries malaria.
Oxitec is also looking at much bigger markets, where the same technology could be applied to developing GM versions of the most common agricultural insect pests (including the diamondback moth, the fall armyworm, and the soybean looper moth).
Behind the heroic justification (bordering on moral blackmail) for approving such new controversial technology – who could be against eradicating malaria? – the corporate strategy behind these products is to seize a much bigger market. In Oxitec’s case, behind the charitable PR lies the goal of replacing the pesticides industry on the crop protection market. Intrexon, Oxitec’s owner, aspires to nothing less than to “design and engineer living systems to address the world’s greatest challenges in health, energy, food, and environmental sustainability”. Third Security, the venture capital firm that is Intrexon’s main shareholder, describes its investment strategy as focussing on companies in a “strategic position ... for both category dominance and financial return”.
Reality however is a bit more sobering. With all of the uncertainty surrounding the safety and efficacy of its products, Intrexon is currently losing a reported $60 million every quarter despite recent deals in the legal cannabis business, and its shares have dropped near 60% since September 2018.
While Oxitec claims positive results and the Dutch food safety agency RIVM has agreed to testing of the company’s GM mosquitoes on the Dutch Caribbean island of Saba, these experiments in particular and the development of gene drives more generally have led to public controversy and debates among scientists, politicians and civil society. Scientists are calling upon all researchers working with gene drives to adopt the same security measures as those required for work with self-propagating pathogens like viruses. In November 2016, 170 groups (including CEO) called upon the UN’s Convention on Biological Diversity to place a moratorium on the technology. Further afield, citizens of Florida have successfully blocked planned local experiments, and Grand Cayman’s government discontinued funding for the project due to “unsatisfactory results”.
Gene drive is a typical example of technology development outpacing regulation, and regulators are just now catching up. EFSA’s opinion therefore comes in at a crucial moment, and the independence of the experts in its working group will be critical to deeming the resulting opinion trustworthy. However, an analysis of the Annual Declarations of Interest Sidenote (ADoI) of these experts shows that EFSA has failed to recruit a panel that will be reasonably independent, or that will even reflect the diversity of positions in the debate.
EFSA’s gene drive working group is dominated by experts with conflicts of interests
The working group includes six experts: Michael Bonsall (Oxford University), Andrea Crisanti (Imperial College London), Leslie George Firbank (Chair, University of Leeds), John Mumford (Imperial College London), Fabien Nogué (INRA, since June 2019) and Ernst Wimmer (Göttingen University).
A screening of the ADoI’s of these experts provides the following information (see annex for a detailed analysis). Among the six experts:
- Only two, who belong to EFSA’s GMO panel, do not have direct financial interests with gene drive developers.
- Two (Bonsall and Wimmer) have direct financial links with Oxitec.
- Two (Crisanti and Mumford) have direct financial links with the Bill & Melinda Gates Foundation.
- One (Mumford) should not have been recruited by EFSA for the working group given the agency’s independence rules.
- Two (Bonsall and Crisanti) have received research funding from DARPA for transgenic mosquito work.
- All of the experts have financial interest in one or more commercial companies whose activity is in the remit of EFSA.
The appointment of these experts was enabled by current loopholes in EFSA’s independence policy (see box). These loopholes were allowed to remain in the 2018 revision of the agency’s independence rules despite repeated criticism by the European Parliament. In 2015, EFSA had already been criticised by the European Ombudsman on a very similar issue, GM insects and the details of the partnership between the University of Oxford and Oxitec - it appears from the declarations of interest that EFSA is now implementing this recommendation.
But there is at least one case in which the expert should not even have been recruited, according to EFSA’s own independence policy. John Mumford’s interests include his role as director of a local farming company in the US, and EFSA’s current independence rules exclude experts with “financial investments with business actors directly or indirectly impacted by EFSA’s operations ... The same holds true for current employment engagements.”
The same expert also declared receiving about 50% of his annual research budget from the Bill & Melinda Gates Foundation’s Target Malaria project on GM mosquitoes. But EFSA’s independence rules also exclude experts who receive more than 25% of their annual research funding from a source whose interests conflict with the mandate of the group they’re applying to.
All this begs important questions: given that the topic is so sensitive, why did EFSA do such a poor job in gathering an independent, or at least diverse, expert group? Why the dominance of experts with financial links to developers when the gene drive issue has gathered such a broad interest in the scientific community?
EFSA provided detailed answers to these questions, stating that in order to identify the members of the group "EFSA together with the chair of the WG agreed on the fields of expertise to cover [Arthropod genetics/genetic control strategies in insects (focusing on mosquitoes and agricultural pests as these are the most likely cases moving to practical applications), Molecular biology and Environmental risk assessment (ecological modelling, population genetics, non/target effects, risk assessment of invasive species)] and EFSA then performed literature searches to identify relevant experts based on the volume and relevance of identified scientific publications".
The agency explained that its current independence rules did not warrant the exclusion of any of these experts (but for example that Pr. Mumford could be a member but not a vice-chair or chair of the group given his patent), notably because it considers public-private partnerships as public funding (which is debatable to say the least). It looks like their assessment of Pr. Mumford's situation is incorrect however, as they explain that "the overall amount of private funding received for research activities conducted in the areas of concern is below the threshold of 25%" whereas Pr. Mumford himself states that his funding from the Bill & Melinda Gates Foundation "accounts for approximately 50% of the research funds managed by me".
Will EFSA keep the working group’s composition unchanged? And after so many years of EFSA’s poor and sometimes non-existent implementation of the European Parliament’s repeated requests to close the loopholes in its independence rules, wouldn’t it be time for the Parliament to step up the pressure a bit?
Further detailed information here: