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European Court of Justice ruling regarding new genetic engineering methods scientifically justified: A commentary on the biased reporting about the recent ruling

Publication date: 20/12/2018

In July 2018, the European Court of Justice (Case C-528/16) ruled that organisms obtained by directed mutagenesis techniques are to be regarded as genetically modified organisms (GMOs) within the meaning of Directive 2001/18. The ruling marked the next round of the dispute around agricultural genetic engineering in Europe. Many of the pros and cons presented in this dispute are familiar from the debate around the first generation of genetic engineering techniques. The current wave of enthusiasm for the new genetic engineering methods, with its claim to make good on the failed promises of the previous wave, seems to point more to an admission of failure of the last generation of genetic engineering than to a true change of paradigm. Regulation is being portrayed as a ban on research and use, which is factually incorrect, and the judges of the European Court of Justice are being defamed as espousing “pseudoscience”. Furthermore, this highly polarised position dominates the media reporting of the new techniques and the court’s ruling. Advocates of the new genetic engineering techniques appear to believe that their benefits are so clear that furnishing reliable scientific evidence is unnecessary. Meanwhile, critics who believe that the institution of science is in a serious crisis are on the increase not just due to the cases of obvious documented scientific misconduct by companies and scientists, but also due to the approach of dividing the world into those categorically for or against genetic engineering. In this construct of irreconcilable opposites, differentiations fall by the wayside. This article is a response to this one-sided and biased reporting, which often has the appearance of spin and lacks journalistic ethics that require journalists to report on different positions in a balanced and factual manner instead of taking positions and becoming undeclared advocates themselves.

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A critical juncture for synthetic biology

Publication date: 12/06/2018

The development of new technologies and their applications often have to navigate regulatory limitations and public attitudes, expectations or resistance – the trajectories of genetically modified crops in the Europe or the success of in vitro fertilization after initial resistance demonstrate how public attitudes and regulation can determine if a technology succeeds or fails.

Academic scientists and companies working on new technologies increasingly must consider these factors and mitigate real and perceived risks of the technology so as to avoid overreaching regulation and public resistance that could threaten innovation. In this context, social science takes an important role by gauging public attitudes about if and how the emergence of new technologies stokes fears and raises hopes.

This article illustrates how the natural sciences and social sciences interacted in the emerging fields of synthetic biology and nanotechnology, specifically the timing and rise of social science research and commentary on the potential impact and risks of these emerging technologies.

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Who’s talking about non-human Genome Editing? Mapping public discussion in the UK

Publication date: 31/05/2018

This report reviews public discussion about Genome Editing in non-human organisms. Its primary goal is to provide a preliminary baseline regarding the kinds of public discussion about, and interactions with, a development in biotechnology with societal significance.

Previous research and experience governing emerging technologies has shown that they need to be developed in ways that are ethical, safe and accountable, that deliver meaningful public value and that foster public trust in democratic institutions. Past experience in Britain suggests public deliberation and discourse has a vital role to play in developing effective governance arrangements and the nation has developed significant institutional expertise in developing such arrangements.

To date, attention has focused largely on the use of Genome Editing in humans. For instance, in 2015 an international summit produced a consensus statement on human Genome Editing. This was followed by a consensus study by the US National Academies of Sciences, Engineering, and Medicine into the ethics and governance of human Genome Editing, published in 2017. However, Genome Editing techniques span virtually all domains of bioscience and biotechnology that rely on altering genetic sequences. In today’s landscape, this means their envisaged uses in both scientific research, as tools, and in developing new technologies or commercially-valuable processes are widespread. It is therefore vital that non-human applications are considered.

In the UK, the Nuffield Council on Bioethics recently concluded an initial study on the ethics of Genome Editing and is undertaking follow up studies on human Genome Editing and Genome Editing in livestock. The Wellcome Trust is currently funding public engagement on Genome Editing as applied to human health and medicine through the Genome Editing Public Engagement Synergy with the National Coordinating Centre for Public Engagement. This review complements the above work by providing baseline information about public discussion of, and public engagement with, Genome Editing in non-human contexts.

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A global observatory for gene editing

Publication date: 21/03/2018

In August 2017, scientists reported that they had used the gene-editing tool CRISPR–Cas9 to correct a mutation in viable human embryos. The work is just one of countless applications of the technique, with which scientists hope to alter plants, animals and humans.

The value of most applications of the technology has barely been exposed to public review. Unless these editorial aspirations are more inclusively debated, well-intentioned research could move humanity closer to a future it has not assented to and might not want.

Over the past three years, leading scientists have called for global deliberation on the possible effects of gene editing on the human future. In our view, the discussions that have taken place fall far short of the expansive, cosmopolitan conversation that is needed.

Free enquiry, the lifeblood of science, does not mean untrammelled freedom to do anything. Society’s unwritten contract with science guarantees scientific autonomy in exchange for a research enterprise that is in the service of, and calibrated to, society’s diverse conceptions of the good. As the dark histories of eugenics and abusive research on human subjects remind us, it is at our peril that we leave the human future to be adjudicated in biotechnology’s own “ecclesiastical courts”.

It is time to invite in voices and concerns that are currently inaudible to those in centres of biological innovation, and to draw on the full richness of humanity’s moral imagination. An international, interdisciplinary observatory would be an important step in this direction.

Resource type: article: Web Page

Rethink public engagement for gene editing

Publication date: 12/03/2018

Over the past three years, thousands of articles have been published about editing genes and genomes. Apart from a public dialogue run by the Royal Society at the end of last year, there’s been little attempt to engage the public on the implications of the technology in a way that could alter the decisions of scientists and policymakers. Indeed, concern about the lack of effective public engagement has motivated several workshops, including one by the intergovernmental Organisation for Economic Co-operation and Development (OECD).

If the history of public engagement surrounding other recent scientific innovations is a guide, efforts to explain the science behind gene editing will intensify, such as through news stories, at science festivals, in public lectures and in museums. And there will be a rash of small, disconnected workshops involving members of the public that are designed to inform specific policy decisions.

If this is all that happens, scientists and policymakers will be ill prepared for the public debate that will almost certainly erupt as applications proliferate.

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The gene-editing conversation

Publication date: 31/01/2018

In 2014 biochemist Jennifer Doudna of the University of California at Berkeley awoke from a nightmare that would shift the focus of her world-class scientific career. Two years earlier, with her colleague Emmanuelle Charpentier, now director of the Max Planck Unit for the Science of Pathogens in Berlin, Doudna had achieved one of the most stunning breakthroughs in the history of biology, becoming the first to use a process called CRISPR-Cas9 to alter the genetic makeup of living organisms. Their “gene-editing” tool would allow scientists to efficiently insert or delete specific bits of DNA with unprecedented precision.

But as applications related to modifying human genes were soon reported in the scientific literature, Doudna began to worry. In the dream, a colleague asked if she would help teach someone how to use CRISPR (Clustered Regularly Interspaced Short Palindrome Repeats). She followed him into a room to be greeted by Adolph Hitler wearing a pig face. The nightmare reinforced her belief that public discussion of the technology was far behind the breakneck pace of its emerging applications. She feared a public backlash that would prevent beneficial forms of gene-editing research from moving forward.

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Why are NGOs sceptical of genome editing?

Publication date: 02/11/2017

In 2016, 107 Nobel Laureates signed an open letter calling on Greenpeace to desist from campaigning against agricultural biotechnology and for governments to reject and resist such campaigning, arguing that “[o]pposition based on emotion and dogma contradicted by data must be stopped”

The letter marked the latest chapter in a long‐running, heated and apparently intractable debate around agricultural biotechnology. Yet, while the arguments by Greenpeace and other non‐governmental organisations (NGOs) against agricultural biotechnology are frequently dismissed as based on emotion and dogma, their opposition is often grounded on more general scepticisms concerning the framing of the problem and its solutions, and the motivations of actors to employ biotechnology in agriculture.

Genome editing is an important case of agricultural biotechnology. In Europe, however, the European Commission has been delaying a decision on the regulation of genome editing and new plant breeding techniques (NPBT) for use in agriculture.

In the meantime, numerous groups are attempting to influence the debate, including biotechnology companies, scientists and NGOs. Scientists and their representations have been particularly prominent in these debates in contrast to a more muted position from commercial interests as companies have adopted a “wait‐and‐see” strategy with regard to the pending regulatory decision on genome editing.

As with earlier debates on genetically modified (GM) crops, NGOs have become the subject of intense criticism from leading scientists who support genome editing in agriculture. The subsequent debates have aroused passions on all sides, but rarely led to greater mutual understanding.

In this paper, we use the case of genome editing to argue that the Nobel Laureate letter may have mischaracterised opposition to agricultural biotechnology as rooted in emotion and dogma.

Rather, our results suggest that this opposition is grounded in three specific types of scepticism concerning the problem framing of food security; the focus on intensive agriculture and technological solutions to the problem of food security; and the motivations for adopting agricultural biotechnology. Below, we describe our methods for analysing NGO scepticism, before providing more detail on each of three types of scepticism.

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Is it only the regulatory status? Broadening the debate on cisgenic plants

Publication date: 26/06/2017

In current debates on emerging technologies for plant breeding in Europe, much attention has been given to the regulatory status of these techniques and their public acceptance. At present, both genetically modified plants with cisgenic approaches—using genes from crossable species—as well as transgenic approaches—using genes from different species—fall under GMO regulation in the EU and both are mandatorily labelled as GMOs. Researchers involved in the early development of cisgenic GM plants convey the message that the potential use and acceptance of cisgenic approaches will be seriously hindered if GMO regulations are not adjusted.

Although the similar treatment and labelling of transgenic and cisgenic plants may be a legitimate concern for the marketability of a cisgenic GM plant, there are concerns around their commercialization that reach beyond the current focus on (de)regulation. In this paper, we will use the development of the cisgenic GM potato that aims to overcome ‘late blight’—the most devastating potato disease worldwide—as a case to argue that it is important to recognize, reflect and respond to broader concerns than the dominant focus on the regulatory ‘burden’ and consumer acceptance. Based on insights we gained from discussing this case with diverse stakeholders within the agricultural sector and potato production in Norway during a series of workshops, we elaborate on additional issues such as the (technical) solution offered; different understandings of the late blight problem; the durability of the potato plant resistance; and patenting and ownership.

Hence, this paper contributes to empirical knowledge on stakeholder perspectives on emerging plant breeding technologies, underscoring the importance to broaden the scope of the debate on the opportunities and challenges of agricultural biotechnologies, such as cisgenic GM plants. The paper offers policy-relevant input to ongoing efforts to broaden the scope of risk assessments of agricultural biotechnologies. We aim to contribute to the recognition of the complex socio-ecological, legal and political dimensions in which these technological developments are entangled as a means to acknowledge, discuss and respond to these concerns and thereby contribute to more comprehensive and responsible developments within agricultural biotechnology.

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Forcing consensus is bad for science and society

Publication date: 12/05/2017

The March for Science that took place in cities around the world on April 22 was intended to “speak for science”, defending evidence-based policies, the strength of peer-reviewed facts and government-funded research.

The marches reflect a growing trend. In February 2017, the text Ethics & Principles for Science & Society Policy-Making, known as the Brussels declaration, was adopted at the American Association for the Advancement of Science’s annual meeting, in Boston. And both the OECD and UNESCO have recently published documents supporting the role of science in informing policy.

Open dialogue between scientists and the societies in which they live and work is, of course, an essential ingredient of democracy. But insisting that science operate under a mandate of consensus, which is the timbre of numerous debates, from vaccines to climate change to genetically modified organisms (GMOs), is not.

Faux unanimity in science actually underexposes policy-relevant scientific and political dissent.

The risks of scientism

Critics of the March for Science, ourselves included, have noted that the march’s program is dangerously close to “scientism” – the adoption of science as a worldview or a religion to the exclusion of other viewpoints.

In doing so, both the march and agreements such as the Brussels declaration ignore the deep crisis facing science, with its daily bulletin of casualties.

Nor is it a good sign that few are reflecting on the power asymmetries that taints what science is used in policy: citizens can’t easily create scientific knowledge, while corporate interests can and do. And evidence has become a currency used by lobbies to purchase political influence.

On the issue of climate change, most scientists have likely formed the opinion that humanity is basically conducting a large-scale geophysical experiment with the planet by increasing the concentration of greenhouse gases.

The problem is not that thesis (it’s essentially correct) but that it is been presented as the scientific consensus concerning the proposed strategy for phasing out fossil fuels. Reasonable minds can differ on the urgency or the feasibility of the strategy for mitigating global warming.

This is one reason why observers on both sides of the “act now!” versus “wait and see” camps can’t agree on how to tame the doubt hounding both climate research and effective responses to the challenge.

What climate, vaccines and GMOs have in common

Childhood vaccination is another hotly contested topic, and the controversy around them has flared for two decades. It started with a paper published in The Lancet in 1998 – later retracted – that purported to show links between vaccines and autism.

The controversy is as fierce as ever today thanks to the involvement of US President Donald Trump and his entourage.

We support vaccination. But we cannot overlook that science holds the responsibility for both starting the scare and for taking a long time to correct its errors. It is unfortunate that we (and others) need to exhibit pro-vaccine credentials in order to attempt a meaningful discussion.

It is also regrettable that vaccines end up being mentioned in same sentence as climate and GMOs. The frequent implication is that science is not the problem but rather the people, who, lacking the knowledge necessary to formulate a clear judgement, end up resisting scientific facts.

This perpetuates the so-called deficit model, an old theory that blames the lay public’s ignorance of science for many problems in the adoption of evidence-based policies.

Golden rice and crimes against humanity

Should science speak with one voice? It did, without doubt, last year when 107 Nobel laureates signed an open letter accusing the environment organisation Greenpeace of crimes against humanity for delaying the commercialisation of a genetically modified rice variety called golden rice.

The Nobel laureates argued that golden rice, which is high in beta carotene, has the potential to “reduce or eliminate much of the death and disease caused by a vitamin A deficiency” and possibly avoid the one to two million “preventable deaths [that] occur annually as a result of this nutritional imbalance”.

Some observers stressed the gravity of the accusations, while prominent journals such as Science and Nature downplayed the letter.

Either way, its content is, frankly, incendiary (more extracts here). In addition to the above claims, the laureates asserted that Greenpeace has “spearheaded opposition” to golden rice. “Opposition based on emotion and dogma contradicted by data must be stopped”, they wrote. “How many poor people in the world must die before we consider this a ‘crime against humanity’?”

Many claims in the letter are either patently false or highly contended. Even the thesis that golden rice is an instrument in the battle against vitamin A deficiency is questionable, according to the International Rice Research Institute. The enhanced beta carotene content of the crop appears to be variable and its value possibly reduced by cooking. Its effectiveness merits further study.

Other scientists have pointed out that vitamin deficiencies are more efficiently fought with better nutrition, direct supplementation, nutrition education programs, the promotion of home gardens, or with the enrichment of staple food with essential nutrients such as vitamin A. All these policies have been implemented successfully over the past decade in many countries.

Golden rice is also a poor solution for vitamin A deficiency because of its lower yield compared to other rice varieties, which could deter farmers from growing it. This is one of the reasons why golden rice is not yet approved for commercialisation.

Finally, its yellow colour makes it more difficult to detect contamination from a dangerous mycotoxin that can cause serious health problems in humans.

All of which is to say that claiming that the introduction of the crop in Asia and Africa by early 2000 would have been beneficial and saved lives is doubtful at best. The evidence does not even contradict the alternative conclusion: that the delayed commercialisation was actually better for the populations concerned.

Safe or fair?

GMOs are a battlefield showing how the issue of framing – deciding on the nature of the problem – is of paramount importance.

For two decades, we have been told that GMOs are safe for human consumption. The tunnel vision on food safety has led to the neglect of other legitimate inquiries on, say, issues of the power, regulation and control of the genetic fabric of our food. Such issues are central to why many constituencies opposed GMO crops.

Relevant, too, and also under discussed, are lessons from unsuccessful GMO adoption.

Today, increasingly more voices are asserting that new technologies should be regulated not only on their benefit-risk profiles but also on their societal context and need, and searching The Conversation for “golden rice” returns a wealth of opinions, indeed – the opposite of a consensus.

This happens because science is a “show me”, not a “trust me”, field. Purporting to speak on behalf of all science, as the Nobel laureates sought to do with golden rice, conflated science, the scientific method and truth.

We live in times of intense ideological confrontations surrounding scientific work. The notion that science works for a common good, which is occasionally imbued with the prestige and authority of Nobel Prize winners, is reassuring. But it is dangerous.

“Science is strictly impersonal; a method and a body of knowledge,” wrote the sociologist John Dewey in the 1930s. “It owes its operation and its consequences to the human beings who use it. It adapts itself passively to the purposes and desires which animate these human beings.”

Dewey called the problem involved in our control of science “the greatest which civilisation has ever had to face”. This calls for a vigilant society and a scientific field that never tires of being critical of itself.

 

This article first appeared in The Conversation and is reprinted here with permission.

Resource type: Word Document (.doc)

Not just about “the science” – science education and attitudes to genetically modified foods among women in Australia

Publication date: 08/02/2017

Previous studies investigating attitudes to genetically modified (GM) foods suggest a correlation between negative attitudes and low levels of science education, both of which are associated with women.

In a qualitative focus group study of Australian women with diverse levels of education, we found attitudes to GM foods were part of a complex process of making “good” food decisions, which included other factors such as locally produced, fresh/natural, healthy and nutritious, and convenient. Women involved in GM crop development and those with health science training differed in how they used evidence to categorize GM foods.

Our findings contribute to a deeper understanding of how GM food, and the role of science and technology in food production and consumption more broadly, is understood and discussed amongst diverse “publics” and across different “sciences,” and to research related to deepening public engagement at the intersection of science and values.

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