Article

The Monsanto Papers: Poisoning the scientific well

May 2018
The International journal of risk & safety in medicine 29(6):1-13

Authors:

California State University, Northridge

Objective: Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company's efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate. Methods: A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined. Results: The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a front for the defense of Monsanto products. Conclusion: The use of third-party academics in the corporate defense of glyhphosate reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation.

The "Monsanto papers" and the nature of ghostwriting and related practices in contemporary peer review scientific literature

Article

Jul 2023

Alastair Matheson

The Monsanto company - now acquired by Bayer - has been accused of ghostwriting articles within peer review literature, with the goal of using influential names to front its content in defence of the herbicide Roundup. Here, I conduct a detailed analysis of three Monsanto review articles and a five-article journal supplement for which detailed information from company emails is publicly available following litigation over Roundup. All the articles had external, but not Monsanto authors, and ghostly practices including ghost authorship, corporate ghost authorship and ghost management were evident in their development. There was clear evidence of ghostwriting - that is, drafting of the manuscript by non-authors - in only two cases. I found no evidence of undeserving authorship among the external authors. The articles complied with the disclosure requirements of their journals, save for the journal supplement. While crude ghostwriting did occur, much of the literature involved subtler practices through which Monsanto exercised control over content, while the attribution of the articles downplayed the company's role - and correspondingly aggrandized that of the external authors. Such practices are widespread within industry journal literature and are the responsibility of byline authors and journals as well as corporations. I discuss these cultural problems and consider remedies. Full-text link: https://www.tandfonline.com/eprint/TTPGGRBQDU7QFSTMSE4G/full?target=10.1080/08989621.2023.2234819

Review of Glyphosate-Based Herbicide and Aminomethylphosphonic Acid (AMPA): Environmental and Health Impacts

Article

Full-text available

Sep 2022

The use of synthetic molecules to achieve specific goals is steadily increasing in the environment, and these molecules adversely impact human health and ecosystem services. Considering the adverse effects, a better understanding of how these molecules behave in the environment and their associated risks is necessary to keep their use acceptably limited. To meet the demands of farmers and combat weed problems, woodlands and farmlands are sprayed with agrochemicals, primarily glyphosate-based herbicides. Farmers increasingly embrace these herbicides containing glyphosate. Glyphosate and aminomethylphosphonic acid (AMPA), a key metabolite of glyphosate, have been reported as toxicological concerns when they become more prevalent in the food chain. The chemical glyphosate has been linked to various health issues in humans and other living organisms, including endocrine disruption, reproductive issues, tumours, non-Hodgkin lymphomas, and liver, heart, and blood problems. Therefore, the current review aims to compile data on glyphosate-based herbicide use in the environment, potential risks to human and ecological health, and various maximum residual limits for crops as suggested by international organizations. As a result, regulatory agencies can advise glyphosate users on safe usage practices and synthesize herbicides more efficiently. Keywords: glyphosate-based herbicide; AMPA; toxicological effect; ecological risk; regulations

Glyphosate, Roundup and the Failures of Regulatory Assessment

Article

Full-text available

Jun 2022

Eva Novotny

Roundup is the most widely used herbicide in agriculture. It contains glyphosate as the ‘active ingredient’, together with formulants. There are various versions of Roundup, with somewhat different effects depending on the formulants. Most genetically-modified crops are designed to tolerate Roundup, thus allowing spraying against weeds during the growing season of the crop without destroying it. Having been so heavily used, this herbicide is now found in the soil, water, air, and even in humans worldwide. Roundup may also remain as a residue on edible crops. Many studies have found harm to the environment and to health, making it imperative to regulate the use of Roundup and to ensure that its various formulations pose no danger when used in the long-term. Unfortunately, regulators may only assess the ‘active ingredient’, glyphosate, and ignore the toxicity of the formulants, which can be far more toxic than the active ingredient. This omission is in violation of a ruling by the Court of Justice of the European Union. There are close ties between the regulators and the industry they are supposed to regulate. Objectionable practices include ‘revolving doors’ between the regulators and the industry, heavy reliance on unpublished papers produced by the industry while dismissing papers published by independent scientists, and strong covert influence on the regulatory process by industry. Although this paper focuses on the European Union (EU), the situation is much the same in the United States.

Lateral Reading on the Open Internet: A District-Wide Field Study in High School Government Classes

Article

Full-text available

Apr 2022

In a study conducted across an urban school district, we tested a classroom-based intervention in which students were taught online evaluation strategies drawn from research with professional fact checkers. Students practiced the heuristic of lateral reading: leaving an unfamiliar website to search the open Web before investing attention in the site at hand. Professional development was provided to high school teachers who then implemented six 50-minute lessons in a district-mandated government course. Using a matched control design, students in treatment classrooms (n = 271) were compared to peers (n = 228) in regular classrooms. A multilevel linear mixed model showed that students in experimental classrooms grew significantly in their ability to judge the credibility of digital content. These findings inform efforts to prepare young people to make wise decisions about the information that darts across their screens.

Can pre-trained Transformers be used in detecting complex sensitive sentences? -- A Monsanto case study

Preprint

Full-text available

Mar 2022

Each and every organisation releases information in a variety of forms ranging from annual reports to legal proceedings. Such documents may contain sensitive information and releasing them openly may lead to the leakage of confidential information. Detection of sentences that contain sensitive information in documents can help organisations prevent the leakage of valuable confidential information. This is especially challenging when such sentences contain a substantial amount of information or are paraphrased versions of known sensitive content. Current approaches to sensitive information detection in such complex settings are based on keyword-based approaches or standard machine learning models. In this paper, we wish to explore whether pre-trained transformer models are well suited to detect complex sensitive information. Pre-trained transformers are typically trained on an enormous amount of text and therefore readily learn grammar, structure and other linguistic features, making them particularly attractive for this task. Through our experiments on the Monsanto trial data set, we observe that the fine-tuned Bidirectional Encoder Representations from Transformers (BERT) transformer model performs better than traditional models. We experimented with four different categories of documents in the Monsanto dataset and observed that BERT achieves better F2 scores by 24.13\% to 65.79\% for GHOST, 30.14\% to 54.88\% for TOXIC, 39.22\% for CHEMI, 53.57\% for REGUL compared to existing sensitive information detection models.

Managing sustainability-related stigmatization through neutralization techniques: The case of a public hearing on pesticide use

Article

Mar 2022
J CLEAN PROD

The objective of this article is to analyze the neutralization techniques that organizations involved in the promotion and use of pesticides use in order to respond to the sustainability-related stigma they face. This study is based on a qualitative content analysis of 77 briefs submitted to a public hearing organized by the National Assembly of Quebec (Canada) on pesticide use, which led to 30 testimonies from stakeholders that either oppose or defend the use of pesticides. This study highlights the sustainability-related stigma faced by organizations vilified because of the environmental, health and ethical issues raised at the hearing. The results also show the impression management strategies and neutralization techniques used by these organizations to respond to the stigma. These techniques are essentially based on neutralizing the stigma (denial, claims of victimhood, defense of social justice and rural traditions) and on the exemplification of existing practices (sustainability stewardship, promotion of science and progress, fight against common enemies). The article contributes to the literature on organizational stigma and on neutralization techniques by proposing an integrative model illustrating the main strategies used by companies to defend the legitimacy of controversial activities. The practical implications of the study and avenues for future research are also discussed. /An abstract-video of the article is available at the following address: https://www.youtube.com/watch?v=UcWmh0yY9k4&t=79s

Legitimizing unsustainable practices: The institutional logics of pro‐pesticide organizations

Article

Feb 2022

The objective of this study is to analyze the institutional logics underlying pesticide use and the resistance displayed by organizations in this sector against social pressures to reduce the use of these substances. This in‐depth study of a public hearing on pesticides set up by the National Assembly of Quebec (Canada) in 2019 shows the often very strong positions held by the relevant stakeholders and how they legitimize their positions. The qualitative content analysis of 77 briefs and 30 testimonies highlights five main institutional logics that contribute to the institutionalization of pesticide use despite the strong opposition it generates: the economic and strategic logic, the regulatory and administrative logic, the tailored advice and support logic, the research and innovation logic, and the traditional, rural and pragmatic logic. These logics show how the objectives, belief systems, and practices shared by pro‐pesticide organizations can hold sway, including over public bodies that are a priori independent but tend to play a buffering and facilitating role in the use of these controversial products. This article contributes to the literature on institutional logics and corporate sustainability by showing how some of these logics can contribute to the continuation of unsustainable practices over time. The article also contributes to the often highly technical literature on the use and impacts of pesticides by proposing an institutional approach that provides an overall picture of the positions of several interdependent organizations and how their underlying belief systems influence practices. Practical implications and avenues for future research are also discussed. /An abstract-video of the article is available at the following address: [https://www.youtube.com/watch?v=lGbbOcc36s4&t=68s].

Flexibilização da regulação de agrotóxicos enquanto oportunidade para a (necro)política brasileira: avanços do agronegócio e retrocessos para a saúde e o ambiente

Article

Full-text available

Jun 2021

O modelo químico-dependente imposto pelo agronegócio expõe a sociedade brasileira a agrotóxicos associados a graves danos à saúde humana e ao ambiente. O avanço da pauta neoliberal no governo agravou o cenário de exposição a essas substâncias em decorrência do desmonte das políticas públicas que criam mecanismos de proteção. Neste sentido, este artigo coloca em foco a flexibilização de regras e normas de regulação de agrotóxicos no Brasil entre os anos de 2019 e 2020. Trata-se de um estudo descritivo e transversal que analisou normas, decisões judiciais e relatórios técnicos publicados no âmbito da União entre janeiro de 2019 e janeiro de 2021, mas com efeitos jurídicos retroativos até dezembro de 2020. Observou-se a liberação de um número recorde de agrotóxicos e a flexibilização de normativas que regulam o registro e o uso dessas substâncias no país, cujos impactos costumam atingir mais intensamente grupos populacionais em situação de maior vulnerabilidade. Argumenta-se que a associação entre o agronegócio e o aprofundamento de vulnerabilidades tem sido mediada por práticas de biopoder voltadas para atender aos interesses do capital financeiro, que determinam sobre quem deve recair os custos do modo capitalista de produção. Este cenário foi agravado com o avanço da pandemia do Covid-19 no país, configurando a necropolítica governamental, que se traduz em uma estratégia de eliminação de povos e comunidades tradicionais, negros, pobres e campesinos.

Towards a more effective reach legislation in protecting human health more effective reach in protecting human health

Article

Feb 2024
TOXICOL SCI

There is growing evidence indicating the substantial contribution of man-made products to an increase in the risk of diseases of civilization. In this article, the Belgian Scientific Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Committee gives a critical view on the working of REACH. The current regulatory framework needs to further evolve taking into account data generated using modern science and technology. There is a need for improved assessment process not only before but also after entering the market. Objectivity, transparency, and the follow-up after market access can be optimized. Additionally, no guidance documents exist for regulation of mixture effects. Further, the lengthiness before regulatory action is a big concern. Decision-making often takes several years leading to uncertainties for both producers and end users. A first proposed improvement is the implementation of independent toxicity testing, to assure objectivity, transparency, and check and improve compliance. A “no data, no market” principle could prevent access of hazardous chemicals to the market. Additionally, the introduction of novel testing could improve information on endpoints such as endocrine disrupting abilities, neurotoxicity, and immunotoxicity. An adapted regulatory framework that integrates data from different sources and comparing the outputs with estimates of exposure is required. Fast toxicology battery testing and toxicokinetic testing could improve speed of decision-making. Hereby, several improvements have been proposed that could improve the current REACH legislation.

The politics of glyphosate regulation: lessons from Sri Lanka’s short-lived ban

Article

Full-text available

Nov 2023

Background Glyphosate is the world’s most used herbicide and a central component of modern industrial agriculture. It has also been linked to a variety of negative health and environmental effects. For instance, the International Agency for Research on Cancer classified glyphosate as “probably carcinogenic to humans” in 2015. This has motivated widespread political demands for stricter glyphosate regulation but so far few governments have followed through. Methods We conduct a case study of Sri Lanka, which in 2015 became the first and so far only country in the world to adopt and implement a complete glyphosate ban. But this ban proved to be short-lived, as it was partially reversed in 2018 (and later fully revoked in 2022). To explain the political causes of Sri Lanka’s pioneering glyphosate ban and its subsequent reversal, we employ process tracing methods drawing on publicly available documents. Our analysis is theoretically guided by the multiple streams framework and the concept of self-undermining policy feedback. Results Glyphosate regulation rose to the top of the Sri Lankan political agenda in 2014 when a local scientist linked glyphosate exposure to an epidemic of Chronic Kidney Disease of Unknown Origin (CKDu). A glyphosate ban was eventually adopted in June 2015 by the newly elected government of Maithripala Sirisena. The ban was a political commitment made to the Buddhist monk Rathana Thero and his party, which had supported Sirisena during his presidential campaign. The ban’s partial reversal in 2018, implemented through sectoral exceptions, was the result of continued lobbying by export-oriented plantation industries and increased political concerns about potential negative effects on the large and structurally powerful tea sector. The reversal was further aided by the scientific community’s failure to corroborate the hypothesized link between glyphosate and CKDu. Conclusions The case of Sri Lanka suggests that strict glyphosate regulation becomes more likely when coupled with locally salient health risks and when decision-making authority is de-delegated from regulatory agencies back to the political executive. Meanwhile, the short-lived nature of the Sri Lankan ban suggests that strict glyphosate regulation faces political sustainability threats, as the apparent lack of cost-effective alternative herbicides motivates persistent business lobbying for regulatory reversal.

Agricultural GMOs and their associated pesticides: misinformation, science, and evidence

Article

Full-text available

Sep 2023

Misinformation has always existed, but it became a major preoccupation during the COVID-19 pandemic due to its ability to affect public health choices, decisions, and policy. In their article, “Misinformation in the media: Global coverage of GMOs 2019–2021” (GM Crops & Food, 17 Nov 2022), Mark Lynas et al. characterise critics of agricultural genetically modified organisms (GMOs) and their associated pesticides as purveyors of “misinformation”. They draw an equivalence between critics of agricultural GMOs and people who make false claims about climate change, COVID-19, and vaccines. We examined their main claims on these GMOs—for example, that there is a scientific consensus that they are safe for health and the environment—in the light of the scientific evidence and public discussion on this topic. We found that their claims are biased and misleading and ignore or omit crucial evidence. We conclude that based on the evidence provided, Lynas et al. article can itself be classed as misinformation and could therefore mislead the general public as well as the scientific community.

Causalité, sévérité et évolution des impacts des pesticides sur les écosystèmes. In : Prone A. (ed.). Impact de I'anthropisation sur la biosphère : biodiversité et fonctionnement des écosystèmes.

Chapter

Full-text available

Jul 2021

Defining and conceptualising the commercial determinants of health

Article

Mar 2023
LANCET

Although commercial entities can contribute positively to health and society there is growing evidence that the products and practices of some commercial actors—notably the largest transnational corporations—are responsible for escalating rates of avoidable ill health, planetary damage, and social and health inequity; these problems are increasingly referred to as the commercial determinants of health. The climate emergency, the non-communicable disease epidemic, and that just four industry sectors (ie, tobacco, ultra-processed food, fossil fuel, and alcohol) already account for at least a third of global deaths illustrate the scale and huge economic cost of the problem. This paper, the first in a Series on the commercial determinants of health, explains how the shift towards market fundamentalism and increasingly powerful transnational corporations has created a pathological system in which commercial actors are increasingly enabled to cause harm and externalise the costs of doing so. Consequently, as harms to human and planetary health increase, commercial sector wealth and power increase, whereas the countervailing forces having to meet these costs (notably individuals, governments, and civil society organisations) become correspondingly impoverished and disempowered or captured by commercial interests. This power imbalance leads to policy inertia; although many policy solutions are available, they are not being implemented. Health harms are escalating, leaving health-care systems increasingly unable to cope. Governments can and must act to improve, rather than continue to threaten, the wellbeing of future generations, development, and economic growth.

Silencing Paritutu

Article

Full-text available

Feb 2023
CRIME LAW SOCIAL CH

This paper exposes the New Zealand (NZ) government’s longstanding campaign to silence evidence of health impacts from dioxin-containing emissions during the production of the herbicide 2,4,5-trichlorophenoxyacetic acid (2,4,5-T) in New Plymouth in the 1960s. Our analysis of official documentation and related literature between 1960–2005 reveals a series of investigations engaging various silencing mechanisms that have culminated in a case of historical pollution. By doing so, they have intensified the acute injuries, chronic disease and multigenerational impacts stemming from the emissions, while discounting the lived experiences of suffering. We argue that silencing be seen as an epistemic violence that is intertwined with, but stands in evidence of, actions to ignore and deny harms that could be utilized in securing the long overdue acknowledgement and appropriate assistance for the Paritutu community.

Poisoning Regulation, Research, Health, and the Environment: The Glyphosate-Based Herbicides Case in Canada

Article

Full-text available

Jan 2023

Despite discourse advocating pesticide reduction, there has been an exponential increase in pesticide use worldwide in the agricultural sector over the last 30 years. Glyphosate-Based Herbicides (GBHs) are the most widely used pesticides on the planet as well as in Canada, where a total of almost 470 million kilograms of declared “active” ingredient glyphosate was sold between 2007 and 2018. GBHs accounted for 58% of pesticides used in the agriculture sector in Canada in 2017. While the independent scientific literature on the harmful health and environmental impacts of pesticides such as GBHs is overwhelming, Canada has only banned 32 “active” pesticide ingredients out of 531 banned in 168 countries, and reapproved GBHs in 2017 until 2032. This article, based on interdisciplinary and intersectoral research, will analyze how as a result of the scientific and regulatory captures of relevant Canadian agencies by the pesticide industry, the Canadian regulation and scientific assessment of pesticides are deficient and lagging behind other countries, using the GBH case as a basis for analysis. It will show how, by embracing industry narratives and biased evidence, by being receptive to industry demands, and by opaque decision making and lack of transparency, Health Canada’s Pest Management Regulatory Agency (PMRA) promotes commercial interests over the imperatives of public health and environmental protection.

Le glyphosate et les journalistes en France: La construction sociale d’un problème public médiatisé (2000-2020)

Article

Dec 2022

Baptiste Schummer

FR. Produit d’une construction médiatique au long cours, qui demeure inachevée au moment de la parution de ce numéro, la mise en problème du glyphosate dans les médias, et plus largement dans l’espace public, constitue un objet particulièrement heuristique à l’aulne d’appréhender le rôle que joue les journalistes quant à la construction des problèmes publics en général, et des problèmes de santé publique en particulier. Substance active du Roundup, désherbant phare de la multinationale phytosanitaire Monsanto, commercialisé en 1975 et qui a longtemps figuré parmi les herbicides les plus vendus au monde, le glyphosate a pourtant tardé à susciter l’attention des médias et du grand public. Hormis quelques publications portant sur les campagnes d’arrachage de cultures OGM « Roundup Ready », tolérantes à ce pesticide, au cours des années 2000, l’intérêt des journalistes à l’égard de celui-ci est très marginal. De surcroît, cette relative médiatisation s’effectue uniquement sous un prisme altermondialiste, anti-Monsanto et anti-OGM. Il faut attendre 2012 pour que le Roundup connaisse une publicisation conséquente, en tant que problème de santé publique cette fois. La parution d’un article scientifique sur la toxicité de l’herbicide occasionne un important battage médiatique, connu sous le nom d’« Affaire Séralini», qui le consacre en menace sanitaire aux yeux de la majorité de la population française. Quant au glyphosate stricto sensu, c’est à partir de mars 2015, date de publication d’un avis d’une agence de l’OMS qualifiant la molécule de « cancérogène probable », que celle-ci devient un véritable « totem médiatique ». Le sommet de ce surinvestissement de la problématique du glyphosate par les journalistes est atteint en janvier 2019, à l’occasion de la diffusion d’un numéro d’« Envoyé Spécial Glyphosate », qui cristallise les tensions dans l’espace médiatique. Tandis que les journalistes pro-glyphosate se fondent sur les normes propres à l’évaluation réglementaire des produits, leurs adversaires convoquent les travaux strictement académiques pour justifier leurs prises de position quant à la (non) dangerosité du biocide. Derrière ces batailles d’expertise, se cachent des pratiques et des représentations professionnelles du bon exercice du métier qui structurent en partie les pôles de la controverse publique. Toutefois, ces luttes journalistiques ne sont pas réductibles à des oppositions déontologiques. Elles relèvent aussi d’un enjeu de double représentation, du réel et de la société, dont les logiques échappent aux seules considérations professionnelles. Décrire les problématiques du monde social revient toujours, pour les journalistes, à représenter certaines franges de celui-ci, et, par conséquent, à représenter certains intérêts sociaux et idéologiques particuliers. Les tentatives de prises de possession d’un problème public comme le glyphosate doivent dès lors être rapportées aux positions sociales de celles et ceux qui les portent dans l’espace médiatique ainsi qu’aux prises de position idéologiques qui leur sont arrimées. *** EN. Glyphosate, as a topic featured in the media, and more broadly in the public arena, is the product of a long-term construction by the media and is still underway at the time of publication of this issue. It forms a particularly heuristic object for understanding the role played by journalists in the construction of public problems in general, and of public health problems in particular. An active ingredient in Roundup, the flagship weed killer of the multinational corporation Monsanto, commercialized since 1975 and for a long time one of the best-selling herbicides in the world, glyphosate has nevertheless been slow to attract the attention of the media and the general public. Apart from a few reports in the 2000’s on the movement to uproot Roundup-ready GMO crops, which are tolerant to the pesticide, journalists' interest in glyphosate remained very marginal. Furthermore, this relative media coverage only took place through an anti-globalization, anti-Monsanto and anti-GMO prism. It was not until 2012 that Roundup was widely publicized as a public health problem. The publication of a scientific article on the toxicity of the herbicide caused major media coverage, known as the "Séralini Affair", which established it as a health threat in the eyes of the majority of the French population. Glyphosate in itself became a real "media totem" starting from March 2015, when a WHO commission published a report classifying the molecule as "probably carcinogen". The climax of this over-coverage of glyphosate by journalists was reached in January 2019, when an episode of "Envoyé Spécial” on Glyphosate was aired, crystallizing tensions in the media on the topic. While pro-glyphosate journalists invoke regulatory standards for the evaluation of products, their critics rely on purely academic research to justify their position on the dangers (or absence of) of the biocide. In the background of these expertise battles lay diverging practices and representations of the profession. This in turn has contributed to the polarization of the public controversy. However, these journalistic disputes are not reducible to deontological oppositions. They also arise from the issue of the double representation of reality and society, the logic of which escapes the only professional considerations. Describing the problems of the social world always means for journalists to represent some fringe of it, and, consequently, to embody specific social and ideological interests. Attempts to claim ownership of a public problem such as glyphosate must therefore be considered in relation to the social positions of those who are involved in the media, as well as their ideological standpoints. *** PT. Produto de uma construção de mídia de longo prazo, que permanece inacabada no momento da publicação desta edição, a questão do glifosato na mídia, e mais amplamente no espaço público, constitui um objeto particularmente heurístico em termos de compreensão do papel desempenhado pelos jornalistas na construção dos problemas públicos em geral, e dos problemas de saúde pública em particular. Ingrediente ativo de Roundup, o principal matador de ervas daninhas da multinacional Monsanto, comercializado em 1975 e há muito tempo um dos herbicidas mais vendidos no mundo, o glifosato demorou a atrair a atenção da mídia e do público em geral. Além de algumas poucas publicações sobre as campanhas para desarraigar as culturas GMO 'Roundup Ready', que são tolerantes a este pesticida, nos anos 2000, o interesse dos jornalistas pelo glifosato foi muito marginal. Além disso, esta relativa cobertura da mídia se deu unicamente de uma perspectiva anti-globalização, anti-Monsanto e anti-GMO. Só a partir de 2012 Roundup passou a ser amplamente divulgado, desta vez como um problema de saúde pública. A publicação de um artigo científico sobre a toxicidade do herbicida foi destaque na mídia, ficando conhecido como o "Caso Séralini", que estabeleceu a substância como uma ameaça à saúde aos olhos da maioria da população francesa. Quanto ao glifosato em si, foi a partir de março de 2015, data da publicação do parecer de uma agência da OMS qualificando a molécula como um "provável carcinógeno", que ele se tornou um tema recorrente na mídia. O auge deste sobreinvestimento na questão do glifosato pelos jornalistas foi atingido em janeiro de 2019, quando foi transmitida uma edição do "Envoyé Spécial Glyphosate", que cristalizou as tensões na mídia. Enquanto os jornalistas pró-glifosato confiavam nos padrões de avaliação de produtos regulamentares, seus oponentes recorriam a um trabalho estritamente acadêmico para justificar suas posições sobre o (não) perigo do biocida. Por trás dessas batalhas por especialização, estão práticas profissionais e representações do exercício adequado da profissão, que em parte estruturam os polos da controvérsia pública. Entretanto, estas lutas jornalísticas não são redutíveis a oposições deontológicas. São também uma questão de dupla representação, da realidade e da sociedade, cuja lógica escapa apenas às considerações profissionais. Para os jornalistas, descrever os problemas do mundo social resume-se sempre a representar certas partes do mesmo e, consequentemente, a representar certos interesses sociais e ideológicos específicos. As tentativas de apropriação de um problema público como o glifosato devem, portanto, estar relacionadas com as posições sociais de quem as transmite no espaço midiático, bem como com as posições ideológicas que estão ligadas a elas. ***

POST brief 0043 Pesticides and Health

Preprint

Full-text available

Sep 2021

Call for papers - Special issue Environmental Science & Policy "Removing pesticides. Competing alternatives for changing agriculture"

Research Proposal

Full-text available

Aug 2021

Toolkit for detecting misused epidemiological methods

Article

Full-text available

Dec 2021
ENVIRON HEALTH-GLOB

Background Critical knowledge of what we know about health and disease, risk factors, causation, prevention, and treatment, derives from epidemiology. Unfortunately, its methods and language can be misused and improperly applied. A repertoire of methods, techniques, arguments, and tactics are used by some people to manipulate science, usually in the service of powerful interests, and particularly those with a financial stake related to toxic agents. Such interests work to foment uncertainty, cast doubt, and mislead decision makers by seeding confusion about cause-and-effect relating to population health. We have compiled a toolkit of the methods used by those whose interests are not aligned with the public health sciences. Professional epidemiologists, as well as those who rely on their work, will thereby be more readily equipped to detect bias and flaws resulting from financial conflict-of-interest, improper study design, data collection, analysis, or interpretation, bringing greater clarity—not only to the advancement of knowledge, but, more immediately, to policy debates. Methods The summary of techniques used to manipulate epidemiological findings, compiled as part of the 2020 Position Statement of the International Network for Epidemiology in Policy (INEP) entitled Conflict-of-Interest and Disclosure in Epidemiology , has been expanded and further elucidated in this commentary. Results Some level of uncertainty is inherent in science. However, corrupted and incomplete literature contributes to confuse, foment further uncertainty, and cast doubt about the evidence under consideration. Confusion delays scientific advancement and leads to the inability of policymakers to make changes that, if enacted, would—supported by the body of valid evidence—protect, maintain, and improve public health. An accessible toolkit is provided that brings attention to the misuse of the methods of epidemiology. Its usefulness is as a compendium of what those trained in epidemiology, as well as those reviewing epidemiological studies, should identify methodologically when assessing the transparency and validity of any epidemiological inquiry, evaluation, or argument. The problems resulting from financial conflicting interests and the misuse of scientific methods, in conjunction with the strategies that can be used to safeguard public health against them, apply not only to epidemiologists, but also to other public health professionals. Conclusions This novel toolkit is for use in protecting the public. It is provided to assist public health professionals as gatekeepers of their respective specialty and subspecialty disciplines whose mission includes protecting, maintaining, and improving the public’s health. It is intended to serve our roles as educators, reviewers, and researchers.

The Cultivation of Social Work Knowledge: Toward a More Robust System of Peer Review

Article

Full-text available

Aug 2021

Daniel J. Dunleavy

In a recent issue of Families in Society, Caputo argues for the “centrality” of peer review in the cultivation of social work knowledge. Specifically, he favors the double-blind model of peer review. In this paper, I argue that social work should adopt a more dynamic set of reviewing practices. First, I define some terminology and discuss the limitations of the current double-blind model. Then, I describe recent trends in peer review, which I argue foster a more robust and open system. I frame this discussion within the context of the wider open science movement and urge social workers to engage with these scholarly practices. In line with these practices and values, a freely accessible preprint is available at: https://osf.io/preprints/socarxiv/rvqze/

Derrière le spectre des « conflits d’intérêts » généralisés. Les agences face aux défis de l’évaluation réglementaire de produits

Article

Full-text available

May 2021

Henri Boullier

Les agences réglementaires sont aujourd’hui au cœur des politiques de protection des populations et de l’environnement, en France comme en Europe. À chaque fois que les effets sanitaires d’un produit font l’objet d’une controverse publique (bisphénol A, benfluorex, glyphosate), ces agences sont mises en accusation : leurs procédures de gestion des conflits d’intérêts et leurs politiques de transparence seraient insuffisantes. Les débats qui ont récemment entouré les évaluations divergentes du Centre international de recherche sur le cancer (CIRC) et de l’Autorité européenne de sécurité des aliments (EFSA) sur la cancérogénicité du glyphosate suggèrent cependant une situation plus complexe. Plutôt qu’un problème de « conflit d’intérêts », les critiques formulées à l’égard de l’EFSA sont liées au fait que les questions qui lui sont posées, les protocoles sur lesquels elle s’appuie, et les données qu’elle utilise, le sont dans un contexte bien particulier : celui de l’évaluation réglementaire de produits en vue de leur commercialisation.

Glyphosate Exposure during Pregnancy and Preterm Birth (More Research Is Needed)

Article

May 2021

Manolis Kogevinas

Will gene-edited and other GM crops fail sustainable food systems?

Chapter

Full-text available

Oct 2020

Allison K Wilson

Abstract: The role of GM crops in supporting sustainable food systems is an ongoing controversy. Underlying this controversy, I will argue, are radically different definitions of agricultural sustainability. One is a narrow definition, based on amelioration of current unsustainable practices, such as the use of synthetic pesticides in agriculture. The other is a broad definition, based on the long-term promotion of human and ecosystem health. In order to assess the sustainability impacts of GM crops, this review first provides (i) a brief summary of the sustainability impacts of herbicide tolerant and Bt pesticidal GM crops and (ii) an overview of GM plant breeding, with a focus on the problem of unintended traits (UTs) in commercial GM crops. These UTs, I argue, are a major yet underappreciated contributor to their lack of sustainability. The review asks next whether new and complex GM traits such as biofortification, or the subset of new GM techniques (nGMs) called gene editing, can benefit sustainable agriculture. Golden Rice provides a case study of unintended traits in GM crops carrying complex traits. Given the failings of Golden Rice, caused in part by UTs, a key question is whether gene editing techniques are more precise and their outcomes more predictable. To address this, the review summarizes the known unintended effects of gene editing and their potential for introducing UTs. I conclude that, despite the promise of new traits and techniques, GM crops, including gene-edited crops, are unlikely to meet either the narrow agronomic, or the broader social and environmental, requirements of sustainable agriculture. The review ends with a discussion of how plant breeders can best support and promote sustainable agriculture, and thus help create sustainable food systems.

WP2 D.2.3 Glyphosate case study

Research

Full-text available

Oct 2020

Sabrina Röttger-Wirtz

Contribution to the REconciling sCience, Innovation and Precaution through the Engagement of Stakeholders Project (RECIPES) funded by the Horizon 2020 Framework Programme of the European Union under Grant Agreement no. 824665.

The precautionary principle and its role in judicial review: glyphosate and the regulatory framework for pesticides

Article

Full-text available

Sep 2020

Sabrina Röttger-Wirtz

The approval renewal of glyphosate as an active substance for pesticides in the EU has also kept the Court of Justice occupied. Within this line of case law, the Blaise case is the most recent one. In this preliminary reference procedure the Court was asked to review the validity of the Plant Protection Products Regulation 1107/2009, examined against the precautionary principle as benchmark. The case is relevant not only for the questions raised about the Regulation, but also as it sheds a light on the – albeit limited – use of the precautionary principle in the judicial review of EU legislative measure.

The impact and toxicity of glyphosate and glyphosate-based herbicides on health and immunity

Article

Full-text available

Jan 2020

Glyphosate, or N-phosphomethyl(glycine), is an organophosphorus compound and a competitive inhibitor of the shikimate pathway that allows aromatic amino acid biosynthesis in plants and microorganisms. Its utilization in broad-spectrum herbicides, such as RoundUp®, has continued to increase since 1974; glyphosate, as well as its primary metabolite aminomethylphosphonic acid, is measured in soils, water, plants, animals and food. In humans, glyphosate is detected in blood and urine, especially in exposed workers, and is excreted within a few days. It has long been regarded as harmless in animals, but growing literature has reported health risks associated with glyphosate and glyphosate-based herbicides. In 2017, the International Agency for Research on Cancer (IARC) classified glyphosate as “probably carcinogenic” in humans. However, other national agencies did not tighten their glyphosate restrictions and even prolonged authorizations of its use. There are also discrepancies between countries’ authorized levels, demonstrating an absence of a clear consensus on glyphosate to date. This review details the effects of glyphosate and glyphosate-based herbicides on fish and mammal health, focusing on the immune system. Increasing evidence shows that glyphosate and glyphosate-based herbicides exhibit cytotoxic and genotoxic effects, increase oxidative stress, disrupt the estrogen pathway, impair some cerebral functions, and allegedly correlate with some cancers. Glyphosate effects on the immune system appear to alter the complement cascade, phagocytic function, and lymphocyte responses, and increase the production of pro-inflammatory cytokines in fish. In mammals, including humans, glyphosate mainly has cytotoxic and genotoxic effects, causes inflammation, and affects lymphocyte functions and the interactions between microorganisms and the immune system. Importantly, even as many outcomes are still being debated, evidence points to a need for more studies to better decipher the risks from glyphosate and better regulation of its global utilization.

Sensitive Information Detection: Recursive Neural Networks for Encoding Context

Preprint

Aug 2020

Jan Neerbek

The amount of data for processing and categorization grows at an ever increasing rate. At the same time the demand for collaboration and transparency in organizations, government and businesses, drives the release of data from internal repositories to the public or 3rd party domain. This in turn increase the potential of sharing sensitive information. The leak of sensitive information can potentially be very costly, both financially for organizations, but also for individuals. In this work we address the important problem of sensitive information detection. Specially we focus on detection in unstructured text documents. We show that simplistic, brittle rule sets for detecting sensitive information only find a small fraction of the actual sensitive information. Furthermore we show that previous state-of-the-art approaches have been implicitly tailored to such simplistic scenarios and thus fail to detect actual sensitive content. We develop a novel family of sensitive information detection approaches which only assumes access to labeled examples, rather than unrealistic assumptions such as access to a set of generating rules or descriptive topical seed words. Our approaches are inspired by the current state-of-the-art for paraphrase detection and we adapt deep learning approaches over recursive neural networks to the problem of sensitive information detection. We show that our context-based approaches significantly outperforms the family of previous state-of-the-art approaches for sensitive information detection, so-called keyword-based approaches, on real-world data and with human labeled examples of sensitive and non-sensitive documents.

Knowledge politics and the Bt cotton success narrative in Burkina Faso

Article

Dec 2020
WORLD DEV

Burkina Faso’s 2008 Bt cotton adoption was Africa’s largest genetically modified (GM) crop introduction principally for small farmers, and became its most celebrated success story. In 2016, however, Burkina Faso announced an abrupt phase-out of Bt cotton, citing millions of dollars of losses due to inferior lint quality. In hindsight, quality issues were conspicuously absent from the success narrative, particularly given that cotton sector actors were aware of problems for a decade. Recent data also reveal significantly lower yield gains and substantial inequalities between farmers, further questioning the success story and the evaluation literature it relied upon. Why and how was such a faulty and incomplete success narrative produced and promoted? To answer this, we draw on extended fieldwork conducted over ten years in Burkina Faso to critically examine how the knowledge used to build this success narrative was produced. We first scrutinize the evaluation literature, pointing out flaws and blindspots in the methodologies and reporting of findings. We then extend our analysis, drawing on political ecology and critical science studies, to focus on the power relations of knowledge production. We focus on three themes and show how (1) the political economic context favored the production of positive results, with Monsanto holding substantial power over the evaluation process, (2) the narrow epistemologies of agronomic evaluation produced “apolitical” knowledge that overlooked how local-level power dynamics shaped data collection, and – in at least two cases (fertilizer application rates and seed costs) – the returns accrued by smaller-scale Bt cotton farmers, (3) the knowledge produced via these processes was used to accrue material benefits to Monsanto and helped to promote GM crops across the continent. We conclude that future GM crop evaluations should be more self-reflexive, critical, and transparent in how power shapes the evaluation process and agricultural outcomes for differentiated farmers.

What is the prospect of a perennial grain revolution of agriculture?

Article

Full-text available

Sep 2024

Non-technical summary Agriculture has been dominated by annual plants, such as all cereals and oilseeds, since the very beginning of civilization over 10,000 years ago. Annual plants are planted and uprooted every year which results in severe disturbance of the soil and disrupts ecosystem services. Science has shown that it is possible to domesticate completely new perennial grain crops, i.e. planted once and harvested year after year. Such crops would solve many of the problems of agriculture, but their development and uptake would be at odds with the current agricultural technology industry. Technical summary Agriculture is arguably the most environmentally destructive innovation in human history. A root cause is the reliance on annual crops requiring uprooting and restarting every season. Most environmental predicaments of agriculture can be attributed to the use of annuals, as well as many social, political, and economic ones. Advances in domestication and breeding of novel perennial grain crops have demonstrated the possibility of a future agricultural shift from annual to perennial crops. Such a change could have many advantages over the current agricultural systems which are to over 80% based on annual crops mainly grown in monocultures. We analyze and review the prospects for such scientific advances to be adopted and scaled to a level where it is pertinent to talk about a perennial revolution. We follow the logic of E.O. Wright's approach of Envisioning Real Utopias by discussing the desirability, viability, and achievability of such a transition. Proceeding from Lakatos' theory of science and Lukes' three dimensions of power, we discuss the obstacles to such a transition. We apply a transition theory lens to formulate four reasons of optimism that a perennial revolution could be imminent within 3–5 decades and conclude with an invitation for research.

Impacto socioeconómico-ambiental de la aspersión de glifosato para la erradicación de cultivos de coca

Article

Full-text available

Aug 2024

El narcotráfico en Colombia ha estado presente desde hace más de cincuenta años, cuando se desató el boom de la marihuana y se ha intensificado con la continua demanda mundial de cocaína, que generó preocupación para los gobiernos. Por este motivo, desde los años 80, los gobiernos le han declarado la guerra a través de la implementación de estrategias de la política antidrogas. Por años, la lucha antidrogas se enfocó, fundamentalmente, en eliminar los cultivos ilícitos, mediante la aspersión aérea de glifosato, un herbicida cuyo uso ha sido polémico y ha suscitado un debate nacional que cuestiona su eficacia en la reducción de áreas sembradas de coca. En este contexto se ha planteado el objetivo de analizar el impacto ambiental y socioeconómico de la aspersión aérea con glifosato. Por consiguiente, la metodología se llevó a cabo mediante la revisión documental realizada con la recopilación, análisis e interpretación de la información obtenida. Los resultados mostraron que el glifosato representa una amenaza para la salud de la población, del medio ambiente y de la economía de subsistencia de las familias campesinas, que han tenido o tienen cultivos de coca. Por esta razón la implementación de esta estrategia, además de ser demasiado costosa, ha sido contraproducente.

“The pesticides burned the grass and the know-how”: Farmers’ oral history and chemoethnography of Swiss Jura slowly violent waterscapes

Article

Dec 2023
GEOFORUM

Debating pesticides use in the indeterminate world

Article

Jul 2023
ENVIRON SCI POLICY

Moving beyond pesticides: Exploring alternatives for a changing food system

Article

Jun 2023
ENVIRON SCI POLICY

This introductory article to the special issue contributes to ongoing debates on pesticides in agriculture by focusing on their alternatives. Through a literature review, we explore the pluralism of those alternatives and the socio-political processes that support or hinder their expansion. The first section examines the obstacles encountered by public policies aimed at reducing pesticide use. Resistances are both external to public decision- making, i.e. agricultural players, agrochemical firms, and internal, related to the existing regulatory mechanisms, including the scientific expertise used to assess risks. The second section introduces the two main families of alternatives to pesticides, and their respective political and scientific underpinnings. On the one hand, solutions based on substitution through alternative technologies, such as biocontrol. On the other hand, solutions based on the systemic redesign of agricultural systems, such as organic farming or agroecology. The third section presents the contributions that make up this special issue. We highlight the political work carried out at the interface between policies, expertise and markets in order to legitimise one or the other alternative. Beyond a strictly technological approach, the papers stress the importance of considering the diversity of components, stake- holders and processes involved at the whole food system level. Farmers and practitioners make complex pro- duction choices and trade-offs. These decisions are influenced by policies and upstream companies, which offer inputs or plant health diagnostic technologies, and by downstream actors, i.e.processors, retailers and policy- makers, who shape the markets for pesticide-free food. The approach we propose here calls for a fresh socio- logical look at policymaking and expertise involved in identifying and dealing with pesticides issues.

The gaming of citation and authorship in academic journals: a warning from medicine

Article

Feb 2023
SOC SCI INFORM

Stuart Macdonald

The use of quantitative performance indicators to measure quality in academic publishing has undercut peer review’s qualitative assessment of articles submitted to journals. The two might have co-existed quite amicably were the most common indicator, citation, on which the journal impact factor is based, not been so susceptible to gaming. Gaming of citations is ubiquitous in academic publishing and referees are powerless to prevent it. The article gives some indication of how the citation game is played. It then moves on from academic publishing in general to look at academic publishing in medicine, a discipline in which authorship is also gamed. Many authors in medicine have made no meaningful contribution to the article that bears their names, and those who have contributed most are often not named as authors. Author slots are openly bought and sold. The problem is magnified by the academic publishing industry and by academic institutions, pleased to pretend that peer review is safeguarding scholarship. In complete contrast, the editors of medicine’s leading journals are scathing about just how ineffectual is peer review in medicine. Other disciplines should take note lest they fall into the mire in which medicine is sinking.

Data Ownership in Food-Related Information

Chapter

Jun 2022

Salvatore Sapienza

This Chapter reconstructs and examines the state of the current debate in data ownership while framing it to the domain of food safety information. Crucially, it identifies a certain degree of convergence towards a new paradigm of ownership that is based on trust. To do so, it examines the traditional concepts of ownership under different perspectives—legal, technical, ethical—and contextualises it to the domain under discussion. New interpretative proposals, based on a new concept of data ownership drawn from the current debate, are then made, together with some possible concrete implementations

Toxicologia crítica aplicada aos agrotóxicos – perspectivas em defesa da vida

Article

Full-text available

Jul 2022

Toxicology is applied to regulatory processes based on the linear basis of the relationship between dose and effect and the possibility of establishing safe exposure conditions. This occurs despite the limitations pointed out by the scientific literature. The conception, definition of methodologies, and the conduct of risk assessment of pesticides ends up meeting economic interests and the definition of security scenarios that are far from reality. The methodological limitations of the studies required for the purpose of registering a pesticide involve: disregarding the interactions between the mixtures used; the failure to predict non-linear dose-response curves (hormetical); compartmentalization of the analyzed outcomes; exposure in critical periods of development; and disregarding of the context, individual and collective diversity and the territories exposed to pesticides, among other aspects discussed in this essay. Critical toxicology proposes that the toxicological assessment should start from the integrality of the problem in the context, presenting proposals that can be adopted in the regulation processes of pesticides and other potentially dangerous substances. KEYWORDS Risk assessment; Toxicology; Agrochemicals; Regulatory frameworks

Toxic Ignorance. How Regulatory Procedures and Industrial Knowledge Jeopardise the Risk Assessment of Chemicals

Article

Apr 2022

Science and Technology Studies research has shown that processes of producing ignorance have been structurally embedded in the evaluation and regulation procedures of the tens of thousands of hazardous chemicals present on the market. What is the role of industrial actors, regulatory experts and scientific data in the institutionalisation of ignorance? Analysing two European expert panels demonstrates that institutionalised ignorance makes it difficult to justify and implement stringent regulations covering all types of population exposure. First, experts get caught up in ways of using scientific data that tend to reinforce industry’s influence on the production of regulatory knowledge (and ignorance). Second, several constraints press experts to play by the rules of the ‘regulatory science’ game, even if this undermines their capacity to challenge the dominant rules of expertise and the relevance of data. Third, the routine functioning of regulatory science tends to favour industry-sponsored studies, while obscuring other knowledge that could have been useful for regulation. Together, these pressures illustrate the concept of toxic ignorance, which weaves together research on institutionalised ignorance, the political economy of science and the social study of toxics. This concept provides a fruitful way of exploring how ignorance is enacted in the public assessment of chemicals, as well as in other instances where the toxic consequences are indirect.

Can pre-trained Transformers be used in detecting complex sensitive sentences? - A Monsanto case study

Conference Paper

Dec 2021

How to Improve Research Funding in Academia? Lessons From the COVID-19 Crisis

Article

Full-text available

Mar 2022

Vlasta Sikimić

Private funding of life sciences has been extensively criticized as lacking objectivity (e.g., Bekelman et al. 2003). However, it is also important to point out that public funding of life sciences faces many objections. In order to improve the system of publicly funded life sciences and its ability to respond to global health challenges such as the COVID-19 pandemic, we should focus on several aspects. First of all, providing existential stability for researchers, in turn, could result in the decrease of academic misconduct. Secondly, COVID-19 vaccines come from all parts of the world and have to be distributed throughout the world, which is a strong argument in favor of the positive stimulation of global science conducted at less-known research institutions and throughout all countries. This brings us to the quest of working on epistemic decolonization and inclusion in contrast to the current elitist paradigm in science. Finally, publicly funded research, which is at the moment mainly focused on foundational questions, should also be extended to applied ones. Public funding of applied research would lead to its development independently of private financial interests.

Response to the IARC 2017 Monograph from the Scientific Community, the Lay Press, the Legal Sector, and the Commercial Sector

Chapter

Feb 2022

Martha Richmond

Given the commercial importance of Roundup Ready™ genetically modified seed, it is, perhaps, not surprising that the strongest response to IARC Monograph 112 has been to the designation of glyphosate as a Category 2A carcinogen. Response to the IARC classifications of the four organophosphate pesticides has not been as strong. In part, this may be because a number of other pesticides can serve the same purposes. Parathion has been withdrawn from use in a large number of countries, so the IARC designation has little economic importance. Many countries have also taken significant steps to stringently regulate or curtail the uses of the other organic phosphates. This is especially true in the EU. Certain targeted uses, nevertheless, do remain, especially for malathion, which has been widely used both agriculturally and in insect vector control. Despite these specific considerations, a number of controversies, both about IARC’s approach to developing the monographs and implications of the classifications remain. This includes debates within the scientific community, the commercial sector, and the lay press.

The Fate of Natural Fibres in Environmental Evaluations: A Question of Volume

Chapter

Feb 2022

Comparing fibres in the discussion surrounding environmental issues has for many years been a numbers game where the aim has been to set them up against each other in order to cherry-pick which fibre is the best to use to save the Planet. Counter-intuitively, natural fibres have received the lowest scores and synthetic fibres have stood out as the ‘winners’. For wool, this has meant spending time, money and effort to disprove that this is the case. Today, one of the most used tools is the Higg Index; and in this tool’s Material Science Index (MSI) the fibres have been ranked for a long time with a single score. Here silk, alpaca, cow leather, cotton and wool had the highest (worst) scores; while polyester and recycled polyester held the best scores. In this chapter we unpack the background for these tools, and how they are being criticised. There is little public knowledge surrounding this discussion, and balancing the information we unpack, is in many ways time-sensitive as the now privately owned Higg Co. is in dialogue with the affected fibre organisations.

Preparing Students for Civic Life in a Digital Age

Article

Jan 2021

Principle-based recommendations for big data and machine learning in food safety: the P-SAFETY model

Article

Full-text available

Oct 2021
AI Soc

Big data and Machine learning Techniques are reshaping the way in which food safety risk assessment is conducted. The ongoing ‘datafication’ of food safety risk assessment activities and the progressive deployment of probabilistic models in their practices requires a discussion on the advantages and disadvantages of these advances. In particular, the low level of trust in EU food safety risk assessment framework highlighted in 2019 by an EU-funded survey could be exacerbated by novel methods of analysis. The variety of processed data raises unique questions regarding the interplay of multiple regulatory systems alongside food safety legislation. Provisions aiming to preserve the confidentiality of data and protect personal information are juxtaposed to norms prescribing the public disclosure of scientific information. This research is intended to provide guidance for data governance and data ownership issues that unfold from the ongoing transformation of the technical and legal domains of food safety risk assessment. Following the reconstruction of technological advances in data collection and analysis and the description of recent amendments to food safety legislation, emerging concerns are discussed in light of the individual, collective and social implications of the deployment of cutting-edge Big Data collection and analysis techniques. Then, a set of principle-based recommendations is proposed by adapting high-level principles enshrined in institutional documents about Artificial Intelligence to the realm of food safety risk assessment. The proposed set of recommendations adopts Safety, Accountability, Fairness, Explainability, Transparency as core principles (SAFETY), whereas Privacy and data protection are used as a meta-principle.

Explore The Big Picture - Forces shaping the future of humanity

Book

Full-text available

Oct 2021

Are you interested in the state of our world? In the future of humanity? Have you ever wondered how the major developments of our time are connected? Are you, in fact, interested in exploring the big picture? The world we live in is undergoing enormous change, and it can feel overwhelming to grasp what it all means, to you, to your family, to your business or job, and to humanity as a whole. Explore The Big Picture takes a deep dive into some of the most significant matters we’re facing today, including climate change, the impact of technology, the development of the world economy, pressing societal challenges, and life beyond Earth. Doing away with complexity, each topic is explored in such a way that it relates to the other topics. Celebrating our achievements and drawing attention to our challenges, Explore The Big Picture cuts through the clutter, leaving readers with a clear vision of what’s at stake and what’s to gain. Using this book enhances your skills in critical thinking, strategic foresight, and interdisciplinary thinking – all vital skills required for addressing complex challenges such as achieving the Sustainable Development Goals. Explore The Big Picture is an open invitation to look beyond the horizon and challenge your thoughts and beliefs, allowing you to take meaningful action that leads to positive change.

Herbicides: A necessary evil? An integrative overview

Chapter

Full-text available

Jan 2021

Herbicides are discussed in this book from various perspectives. With dozens of modes of action, thousands of products, and a worldwide use of about 1 million tons per year, herbicides are among the most important chemicals—used not only in conventional agriculture but also for nonagricultural purposes. Information compiled in this book on toxicological and ecotoxicological impacts, widespread resistance of weed species, and the herbicide-induced promotion of plant diseases pleads for a reconsideration of current herbicide uses. Rather than replacing problematic herbicides by others, a paradigm shift in weed control seems inevitable. A wealth of alternative methods is available. Implementation of herbicide reduction strategies could be complemented by improved monitoring, better analytical tools, and more legislative liberty for regulation by local authorities or nations. Instead of trying to eradicate weeds, future management programs should aim to control them at a level that is yield-sustainable.

PASCAL’S WAGER REFRAMED:: Toward Trustworthy Climate Policy Assessments for Risk Societies

Chapter

Apr 2021

GHOSTWRITING O ESCRITURA FANTASMA EN LA FACTORÍA ALIMENTARIA. HIPÓTESIS DE INVESTIGACIÓN JURÍDICA SOBRE UN POSIBLE CONTRATO ATÍPICO

Article

Nov 2020

Santiago Mirande

p>En la actual era de posverdad y sociedad hipermoderna la incerteza ha comenzado a ser prediseñada por actores de la factoría alimentaria en un contexto de ciencia politizada y de capitalismo digital. El ghostwriting refiere a una modalidad autoral o de escritura fantasma mediante la cual un sujeto tiene injerencia sobre una obra que luego es publicada, divulgada y/o difundida con el nombre de otro sujeto. El ghostwriter es el verdadero autor o ideólogo del contenido de la obra pero permanece oculto ante el destinatario o público. El signatory writer es el autor o escritor firmante; es el autor no verdadero pero aparente. Ello define o tipifica la categoría general de ghostwriting. Se ensayan dos subcategorías de ghostwriting que pueden construirse según la incidencia o injerencia del ghostwriter en la obra. Una subcategoría es el ghostwriting literario o artístico, históricamente presente en producciones literarias en que un ghostwriter elabora un contenido y luego un signatorywriter lo difunde con su nombre. A continuación se destaca la otra subcategoría: el ghostwriting pseudocientífico , en el cual el ghostwriter (por ejemplo, una corporación que elabora y comercializa alimentos) crea el contenido medular de un estudio pseudocientífico para que las conclusiones le sean favorables. El signatorywriter (un especialista o experto) escribe la obra e incluye el contenido que le es indicado por aquel. Estos pseudoestudios no son ni objetivos ni independientes, por lo tanto, no son científicos. Implican una manipulación, tergiversación o distorsión de la verdad y de la información. En definitiva, el ghostwriting pseudocientífico genera fake news científicas . Se han realizado estudios científicos que demuestran la existencia cada vez mayor de este hecho por parte de la industria alimentaria, entre otros. A partir de lo dispuesto por el art. 70 de la Constitución R. O. Uruguay (arts. 75.19 y 125 de la Constitución de la Nación Argentina), el cual protege el desarrollo de la investigación científica, y otras normas del sistema jurídico uruguayo, se plantean algunas hipótesis de investigación jurídica.</p

GHOSTWRITING O ESCRITURA FANTASMA EN LA FACTORÍA ALIMENTARIA. HIPÓTESIS DE INVESTIGACIÓN JURÍDICA SOBRE UN POSIBLE CONTRATO ATÍPICO

Article

Nov 2020

Santiago Mirande

Associação da interação do herbicida glifosato com receptor de linfócitos B humano (CD20) ao desenvolvimento de linfomas por meio de ferramentas de bioinformática

Conference Paper

Jan 2020

Pesticides Bring the War on Nature to the Chesapeake Bay

Chapter

Aug 2020

The end of World War II brought DDT and other organic pesticides to Chesapeake Bay agriculture. These new insecticides and herbicides supported the industrialization of farming that primarily produced feedstock for the manufacture of animal-based foods. The widespread use of these new chemicals constituted a war on nature with the intent of poisoning non-human animals that ate crops and weeds that competed for land, space, light, nutrients, and water. The pesticides tended to fail as the artificial selection they imposed on their targets promoted the evolution of resistant pests. In the 1960s, herbicides replaced insecticides as the dominant pesticide. Genetic engineered pesticide resistant corn and soybean facilitated the marketing of the generalist herbicides glyphosate, and later dicamba. The genetically engineered crops and pesticide dominate the animal feedstock agriculture in the region. Years of pesticide use have contaminated water, soils, fish and wildlife. The pesticides threaten both human health and that of the environment. Adopting sustainable organic agricultural practices can end the war on nature and help recover the health of the Chesapeake Bay ecosystem and that of its people.

Industry-Corrupted Psychiatric Trials

Article

Full-text available

Dec 2017

The goal of this paper is to expose the research misconduct of pharmaceutical industry-sponsored clinical trials via three short case studies of corrupted psychiatric trials that were conducted in the United States. We discuss the common elements that enable the misrepre-sentation of clinical trial results including ghostwriting for medical journals, the role of key opinion leaders as co-conspirators with the pharmaceutical industry and the complicity of top medical journals in failing to uphold standards of science and peer review. We conclude that the corruption of industry-sponsored clinical trials is one of the major obstacles facing evidence-based medicine.

Retracting Inconclusive Research: Lessons from the S,ralini GM Maize Feeding Study

Article

Full-text available

Aug 2015

David B Resnik

In September 2012, Gilles-Eric Séralini and seven coauthors published an article in Food and Chemical Toxicology claiming that rats fed Roundup©-resistant genetically modified maize alone, genetically modified maize with Roundup©, or Roundup© for 2 years had a higher percentage of tumors and kidney and liver damage than normal controls. Shortly after this study was published, numerous scientists and several scientific organizations criticized the research as methodologically and ethically flawed. In January 2014, the journal retracted the article without the authors’ consent on the grounds that the research was inconclusive. In June 2014, Environmental Sciences Europe published a slightly modified version of the retracted paper. The publication, retraction and subsequent republication of the Séralini study raise important scientific and ethical issues for journal editors. Decisions to retract an article should be made on the basis of well-established policies. Articles should be retracted only for serious errors that undermine the reliability of the data or results, or for serious ethical lapses, such as research misconduct or mistreatment of animal or human subjects. Inconclusiveness, by itself, is not a sufficient reason for retracting an article, though a flawed study design might be. Retracted articles that are submitted for republication should undergo scientific review to ensure that they meet appropriate standards. Republished articles should be linked to the original, retracted publication. Journals that are reviewing studies with significant scientific and social implications should take special care to ensure that peer review is rigorous and fair.

Evaluation of carcinogenic potential of the herbicide glyphosate, drawing on tumor incidence data from fourteen chronic/carcinogenicity rodent studies

Article

Full-text available

Feb 2015

Glyphosate, an herbicidal derivative of the amino acid glycine, was introduced to agriculture in the 1970s. Glyphosate targets and blocks a plant metabolic pathway not found in animals, the shikimate pathway, required for the synthesis of aromatic amino acids in plants. After almost forty years of commercial use, and multiple regulatory approvals including toxicology evaluations, literature reviews, and numerous human health risk assessments, the clear and consistent conclusions are that glyphosate is of low toxicological concern, and no concerns exist with respect to glyphosate use and cancer in humans. This manuscript discusses the basis for these conclusions. Most toxicological studies informing regulatory evaluations are of commercial interest and are proprietary in nature. Given the widespread attention to this molecule, the authors gained access to carcinogenicity data submitted to regulatory agencies and present overviews of each study, followed by a weight of evidence evaluation of tumor incidence data. Fourteen carcinogenicity studies (nine rat and five mouse) are evaluated for their individual reliability, and select neoplasms are identified for further evaluation across the data base. The original tumor incidence data from study reports are presented in the online data supplement. There was no evidence of a carcinogenic effect related to glyphosate treatment. The lack of a plausible mechanism, along with published epidemiology studies, which fail to demonstrate clear, statistically significant, unbiased and non-confounded associations between glyphosate and cancer of any single etiology, and a compelling weight of evidence, support the conclusion that glyphosate does not present concern with respect to carcinogenic potential in humans.

Pesticides and human health

Article

Full-text available

Dec 2014

Pesticides, including herbicides, insecticides, fungicides, fumigants and rodenticides, provide important benefits in public health, food production and aesthetics (http://www.epa.gov/agriculture/ag101/pestbenefits.html). Unlike most other important chemicals, pesticides are designed to impact living systems (http://www.cdc.gov/niosh/docs/81-123/). Consequently there has long been a concern about environmental and human consequences of widespread pesticide use. Carson1 effectively voiced this concern and documented some problems in her 1962 book, Silent Spring. Global pesticide use increased dramatically between the 1960s and 1990s, and more slowly thereafter, but large increases continue to occur in many developing countries.2 The estimated worldwide use in 2007 was 5211 million pounds of active ingredients, with herbicides accounting for the major use in agriculture, and about 40% of the use overall.3 To place this figure in context, it is close to one pound for each of the 6.6 billion people then inhabiting the globe, albeit with unequal distribution. Human occupational exposure is expected during pesticide production and application, but the general population can also be exposed through drift, contamination of water and food supplies, and biological concentration through the food chain.4 In addition, pesticide use for vector control and elimination of nuisance pests is an important exposure source for a considerable portion of the world population, and is an especially important source of exposure indoors.5 These varied pathways have resulted in such ubiquitous exposure that persistent pesticides or their metabolites can be found at low levels in biological tissues of much of the world's population. This includes many who may be …

Of Sophists and Spin-Doctors: Industry-Sponsored Ghostwriting and the Crisis of Academic Medicine

Article

Full-text available

Jan 2010

Leemon McHenry

Ghostwriting for medical journals has become a major, but largely invisible, factor contributing to the problem of credibility in academic medicine. In this paper I argue that the pharmaceutical marketing objectives and use of medical communication firms in the production of ghostwritten articles constitute a new form of sophistry. After identifying three distinct types of medical ghostwriting, I survey the known cases of ghostwriting in the literature and explain the harm done to academic medicine and to patients. Finally, I outline steps to address the problem and restore the integrity of the medical literature.

Prevalence of Articles With Honorary Authors and Ghost Authors in Peer-Reviewed Medical Journals

Article

Full-text available

Aug 1998

Authorship in biomedical publications establishes accountability, responsibility, and credit. Misappropriation of authorship undermines the integrity of the authorship system, but accurate data on its prevalence are limited. To determine the prevalence of articles with honorary authors (named authors who have not met authorship criteria) and ghost authors (individuals not named as authors but who contributed substantially to the work) in peer-reviewed medical journals and to identify journal characteristics and article types associated with such authorship misappropriation. Mailed, self-administered, confidential survey. A total of 809 corresponding authors (1179 surveyed, 69% response rate) of articles published in 1996 in 3 peer-reviewed, large-circulation general medical journals (Annals of Internal Medicine, JAMA, and The New England Journal of Medicine) and 3 peer-reviewed, smaller-circulation journals that publish supplements (American Journal of Cardiology, American Journal of Medicine, and American Journal of Obstetrics and Gynecology). Prevalence of articles with honorary authors and ghost authors, as reported by corresponding authors. Of the 809 articles, 492 were original research reports, 240 were reviews and articles not reporting original data, and 77 were editorials. A total of 156 articles (1 9%) had evidence of honorary authors (range, 11%-25% among journals); 93 articles (11%) had evidence of ghost authors (range, 7%-16% among journals); and 13 articles (2%) had evidence of both. The prevalence of articles with honorary authors was greater among review articles than research articles (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.6) but did not differ significantly between large-circulation and smaller-circulation journals (OR, 1.4; 95% CI, 0.96-2.03). Compared with similar-type articles in large-circulation journals, articles with ghost authors in smaller-circulation journals were more likely to be reviews (OR, 4.2; 95% CI, 1.5-13.5) and less likely to be research articles (OR, 0.49; 95% CI, 0.27-0.88). A substantial proportion of articles in peer-reviewed medical journals demonstrate evidence of honorary authors or ghost authors.

Ghost Management: How Much of the Medical Literature Is Shaped Behind the Scenes by the Pharmaceutical Industry?

Article

Full-text available

Oct 2007
PLOS MED

Sergio Sismondo

Anecdotes have shown that some articles on profitable drugs are constructed by and shepherded through publication by pharmaceutical companies and their agents, whose influence is largely invisible to readers. This is ghost-management, the substantial but unrecognized research, analysis, writing, editing and/or facilitation behind publication. Publicly available documents suggest that these practices extremely widespread affecting up to 40% of clinical trial reports in key periods but it has been unclear how representative these documents are. This article presents the results of an investigative sampling of the self-presentation of publication planning services, and presents this and other evidence of a sizable publication planning industry. Thus different lines of evidence indicate that ghost-management is a common and important phenomenon, strongly affecting the published medical literature in the service of marketing.

Pharmageddon

Book

Mar 2012

David Healy

Whitewash: The story of a weed killer, cancer, and the corruption of science

Book

Jan 2017

C. Gillam

It’s the pesticide on our dinner plates, a chemical so pervasive it’s in the air we breathe, our water, our soil, and even found increasingly in our own bodies. Known as Monsanto’s Roundup by consumers, and as glyphosate by scientists, the world’s most popular weed killer is used everywhere from backyard gardens to golf courses to millions of acres of farmland. For decades it’s been touted as safe enough to drink, but a growing body of evidence indicates just the opposite, with research tying the chemical to cancers and a host of other health threats. In this volume, the author uncovers one of the most controversial stories in the history of food and agriculture, exposing new evidence of corporate influence. The author introduces readers to farm families devastated by cancers which they believe are caused by the chemical, and to scientists whose reputations have been smeared for publishing research that contradicted business interests. Readers learn about the arm-twisting of regulators who signed off on the chemical, echoing company assurances of safety even as they permitted higher residues of the pesticide in food and skipped compliance tests. And, in startling detail, the author reveals secret industry communications that pull back the curtain on corporate efforts to manipulate public perception. This book is more than an exposé about the hazards of one chemical or even the influence of one company. It’s a story of power, politics, and the deadly consequences of putting corporate interests ahead of public safety.

A review of the carcinogenic potential of glyphosate by four independent expert panels and comparison to the IARC assessment

Article

Sep 2016
CRIT REV TOXICOL

The International Agency for Research on Cancer (IARC) published a monograph in 2015 concluding that glyphosate is “probably carcinogenic to humans” (Group 2A) based on limited evidence in humans and sufficient evidence in experimental animals. It was also concluded that there was strong evidence of genotoxicity and oxidative stress. Four Expert Panels have been convened for the purpose of conducting a detailed critique of the evidence in light of IARC’s assessment and to review all relevant information pertaining to glyphosate exposure, animal carcinogenicity, genotoxicity, and epidemiologic studies. Two of the Panels (animal bioassay and genetic toxicology) also provided a critique of the IARC position with respect to conclusions made in these areas. The incidences of neoplasms in the animal bioassays were found not to be associated with glyphosate exposure on the basis that they lacked statistical strength, were inconsistent across studies, lacked dose-response relationships, were not associated with preneoplasia, and/or were not plausible from a mechanistic perspective. The overall weight of evidence from the genetic toxicology data supports a conclusion that glyphosate (including GBFs and AMPA) does not pose a genotoxic hazard and therefore, should not be considered support for the classification of glyphosate as a genotoxic carcinogen. The assessment of the epidemiological data found that the data do not support a causal relationship between glyphosate exposure and non-Hodgkin’s lymphoma while the data were judged to be too sparse to assess a potential relationship between glyphosate exposure and multiple myeloma. As a result, following the review of the totality of the evidence, the Panels concluded that the data do not support IARC’s conclusion that glyphosate is a “probable human carcinogen” and, consistent with previous regulatory assessments, further concluded that glyphosate is unlikely to pose a carcinogenic risk to humans.

International Agency for Research on Cancer Iarc monographs on the evaluation of carcinogenic risks to humans

Article

Jan 2002

Iarc

Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?

Article

Jan 2004

Republished study: Long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize

Article

Jun 2014

The health effects of a Roundup-tolerant NK603 genetically modified (GM) maize (from 11% in the diet), cultivated with or without Roundup application and Roundup alone (from 0.1 ppb of the full pesticide containing glyphosate and adjuvants) in drinking water, were evaluated for 2 years in rats. This study constitutes a follow-up investigation of a 90-day feeding study conducted by Monsanto in order to obtain commercial release of this GMO, employing the same rat strain and analyzing biochemical parameters on the same number of animals per group as our investigation. Our research represents the first chronic study on these substances, in which all observations including tumors are reported chronologically. Thus, it was not designed as a carcinogenicity study. We report the major findings with 34 organs observed and 56 parameters analyzed at 11 time points for most organs. Biochemical analyses confirmed very significant chronic kidney deficiencies, for all treatments and both sexes; 76% of the altered parameters were kidney-related. In treated males, liver congestions and necrosis were 2.5 to 5.5 times higher. Marked and severe nephropathies were also generally 1.3 to 2.3 times greater. In females, all treatment groups showed a two- to threefold increase in mortality, and deaths were earlier. This difference was also evident in three male groups fed with GM maize. All results were hormone- and sex-dependent, and the pathological profiles were comparable. Females developed large mammary tumors more frequently and before controls; the pituitary was the second most disabled organ; the sex hormonal balance was modified by consumption of GM maize and Roundup treatments. Males presented up to four times more large palpable tumors starting 600 days earlier than in the control group, in which only one tumor was noted. These results may be explained by not only the non-linear endocrine-disrupting effects of Roundup but also by the overexpression of the EPSPS transgene or other mutational effects in the GM maize and their metabolic consequences. Our findings imply that long-term (2 year) feeding trials need to be conducted to thoroughly evaluate the safety of GM foods and pesticides in their full commercial formulations.

Review of genotoxicity studies of glyphosate and glyphosate-based formulations

Article

Mar 2013
CRIT REV TOXICOL

Abstract An earlier review of the toxicity of glyphosate and the original Roundup™-branded formulation concluded that neither glyphosate nor the formulation poses a risk for the production of heritable/somatic mutations in humans. The present review of subsequent genotoxicity publications and regulatory studies of glyphosate and glyphosate-based formulations (GBFs) incorporates all of the findings into a weight of evidence for genotoxicity. An overwhelming preponderance of negative results in well-conducted bacterial reversion and in vivo mammalian micronucleus and chromosomal aberration assays indicates that glyphosate and typical GBFs are not genotoxic in these core assays. Negative results for in vitro gene mutation and a majority of negative results for chromosomal effect assays in mammalian cells add to the weight of evidence that glyphosate is not typically genotoxic for these endpoints in mammalian systems. Mixed results were observed for micronucleus assays of GBFs in non-mammalian systems. Reports of positive results for DNA damage endpoints indicate that glyphosate and GBFs tend to elicit DNA damage effects at high or toxic dose levels, but the data suggest that this is due to cytotoxicity rather than DNA interaction with GBF activity perhaps associated with the surfactants present in many GBFs. Glyphosate and typical GBFs do not appear to present significant genotoxic risk under normal conditions of human or environmental exposures.

2012. Séralini et al. Long Term Toxicity of a Roundup Herbicide and a Roundup-Tolerant Genetically Modified Maize

Data

Nov 2012

Oxidative stress responses of rats exposed to Roundup and its active ingredient glyphosate

Article

Nov 2009

Nahla S. El-Shenawy

Glyphosate is the active ingredient and polyoxyethyleneamine, the major component, is the surfactant present in the herbicide Roundup formulation. The objective of this study was to analyze potential cytotoxicity of the Roundup and its fundamental substance (glyphosate). Albino male rats were intraperitoneally treated with sub-lethal concentration of Roundup (269.9mg/kg) or glyphosate (134.95mg/kg) each 2 days, during 2 weeks. Hepatotoxicity was monitored by quantitative analysis of the serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) activities, total protein, albumin, triglyceride and cholesterol. Creatinine and urea were used as the biochemical markers of kidney damages. The second aim of this study to investigate how glyphosate alone or included in herbicide Roundup affected hepatic reduced glutathione (GSH) and lipid peroxidation (LPO) levels of animals as an index of antioxidant status and oxidative stress, respectively, as well as the serum nitric oxide (NO) and alpha tumour necrosis factor (TNF-α) were measured. Treatment of animals with Roundup induced the leakage of hepatic intracellular enzymes, ALT, AST and ALP suggesting irreversible damage in hepatocytes starting from the first week. It was found that the effects were different on the enzymes in Roundup and glyphosate-treated groups. Significant time-dependent depletion of GSH levels and induction of oxidative stress in liver by the elevated levels of LPO, further confirmed the potential of Roundup to induce oxidative stress in hepatic tissue. However, glyphosate caused significant increases in NO levels more than Roundup after 2 weeks of treatment. Both treatments increased the level of TNF-α by the same manner. The results suggest that excessive antioxidant disruptor and oxidative stress is induced with Roundup than glyphosate.

A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: Emerging safety concerns and lessons learned

Article

Jun 2011

Background context: Increasingly, reports of frequent and occasionally catastrophic complications associated with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in spinal fusion surgeries are being published. In the original peer review, industry-sponsored publications describing the use of rhBMP-2 in spinal fusion, adverse events of these types and frequency were either not reported at all or not reported to be associated with rhBMP-2 use. Some authors and investigators have suggested that these discrepancies were related to inadequate peer review and editorial oversight. Purpose: To compare the conclusions regarding the safety and related efficacy published in the original rhBMP-2 industry-sponsored trials with subsequently available Food and Drug Administration (FDA) data summaries, follow-up publications, and administrative and organizational databases. Study design: Systematic review. Methods: Results and conclusions from original industry-sponsored rhBMP-2 publications regarding safety and related efficacy were compared with available FDA data summaries, follow-up publications, and administrative and organizational database analyses. Results: There were 13 original industry-sponsored rhBMP-2 publications regarding safety and efficacy, including reports and analyses of 780 patients receiving rhBMP-2 within prospective controlled study protocols. No rhBMP-2-associated adverse events (0%) were reported in any of these studies (99% confidence interval of adverse event rate <0.5%). The study designs of the industry-sponsored rhBMP-2 trials for use in posterolateral fusions and posterior lateral interbody fusion were found to have potential methodological bias against the control group. The reported morbidity of iliac crest donor site pain was also found to have serious potential design bias. Comparative review of FDA documents and subsequent publications revealed originally unpublished adverse events and internal inconsistencies. From this review, we suggest an estimate of adverse events associated with rhBMP-2 use in spine fusion ranging from 10% to 50% depending on approach. Anterior cervical fusion with rhBMP-2 has an estimated 40% greater risk of adverse events with rhBMP-2 in the early postoperative period, including life-threatening events. After anterior interbody lumbar fusion rates of implant displacement, subsidence, infection, urogenital events, and retrograde ejaculation were higher after using rhBMP-2 than controls. Posterior lumbar interbody fusion use was associated with radiculitis, ectopic bone formation, osteolysis, and poorer global outcomes. In posterolateral fusions, the risk of adverse effects associated with rhBMP-2 use was equivalent to or greater than that of iliac crest bone graft harvesting, and 15% to 20% of subjects reported early back pain and leg pain adverse events; higher doses of rhBMP-2 were also associated with a greater apparent risk of new malignancy. Conclusions: Level I and Level II evidence from original FDA summaries, original published data, and subsequent studies suggest possible study design bias in the original trials, as well as a clear increased risk of complications and adverse events to patients receiving rhBMP-2 in spinal fusion. This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications.

Bending Science: How Special Interests Corrupt Public Health Research

Article

Jan 2009

Thomas Owen Mcgarity

Corporate influences on epidemiology

Article

Jan 2007
EPIDEMIOL PREV

Neil Pearce

Corporate influences on epidemiology have become stronger and more pervasive in the last few decades, particularly in the contentious fields of pharmacoepidemiology and occupational epidemiology. For every independent epidemiologist studying the side effects of medicines and the hazardous effects of industrial chemicals, there are several other epidemiologists hired by industry to attack the research and to debunk it as 'junk science'. In some instances these activities have gone as far as efforts to block publication. In many instances, academics have accepted industry funding which has not been acknowledged, and only the academic affiliations of the company-funded consultants have been listed. These activities are major threats to the integrity of the field, and its survival as a scientific discipline. There is no simple solution to these problems. However, for the last two decades there has been substantial discussion on ethics in epidemiology, partly in response to the unethical conduct of many industry-funded consultants. Professional organizations, such as the International Epidemiological Association, can play a major role in encouraging and supporting epidemiologists to assert positive principles of how science should work, and how it should be applied to public policy decisions, rather than simply having a list of what not to do.

Industry-Sponsored Ghostwriting in Clinical Trial Reporting: A Case Study

Article

Jul 2008

In this case study from litigation, we show how ghostwriting of clinical trial results can contribute to the manipulation of data to favor the study medication. Study 329 for paroxetine pediatric use was negative for efficacy and positive for harm. Yet the ghostwritten publication from this study concluded that paroxetine provided evidence of efficacy and safety and continues to be influential. Despite the role of named authors in revisions of the manuscript, the sponsor company remained in control of the message.

Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans

Article

May 2000

Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with glyphosate. Likewise there were no adverse effects in reproductive tissues from animals treated with glyphosate, AMPA, or POEA in chronic and/or subchronic studies. Results from standard studies with these materials also failed to show any effects indicative of endocrine modulation. Therefore, it is concluded that the use of Roundup herbicide does not result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. For purposes of risk assessment, no-observed-adverse-effect levels (NOAELs) were identified for all subchronic, chronic, developmental, and reproduction studies with glyphosate, AMPA, and POEA. Margins-of-exposure for chronic risk were calculated for each compound by dividing the lowest applicable NOAEL by worst-case estimates of chronic exposure. Acute risks were assessed by comparison of oral LD50 values to estimated maximum acute human exposure. It was concluded that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.

Science in the private interest: has the lure of profits corrupted biomedical research?

Article

Feb 2006

Sheldon Krimsky

Not Available

Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients. London: Fourth Estate

B Goldacre

RETRACTED: Long term toxicity of a roundup herbicide and a roundup-tolerant genetically modified maize

Jan 2014
244

Food and Chemical Toxicology

Long term toxicity of a roundup herbicide and a roundup-tolerant genetically modified maize

Séralini

World Health Organization (WHO), International Agency for Research on Cancer (IARC) IARC Monographs on the Evaluation of Carcinogen Risks to Humans

Iarc
Glyphosate

The Monsanto Papers: Poisoning the scientific well

Abstract

No full-text available

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