A group of toxicologists with tenuous expertise and veiled conflicts of interest are working to derail the implementation of European regulations on synthetic substances that are toxic at very low doses.
Editor's note: This article was originally published at Le Monde and is republished here with permission.
They call themselves "prominent" specialists; they are not.
They solemnly declare that they have no conflict of interest; however, half of them have collaborated with the chemical, pesticide, food or cosmetics industry over the last three years. Radically opposed to any regulation of endocrine--disrupting chemicals in Europe, 19 scientists have chosen to voice their opinions while an important decision-making process is underway in Brussels.
In an editorial published in early April 2020, they minimize the potential severity of the effects of EDCs, which are ubiquitous in the environment and in living things — from babies to sea snails.
"Human exposure to synthetic endocrine-disrupting chemicals is generally negligible", they say, and "further studies and regulatory consequences will not be warranted."
In 2013, a similar initiative by the core group of the same toxicologists contributed to derailing an ongoing EU legislative process and delayed the elaboration of the EDC regulation for several years.
Published simultaneously in six scholarly journals specializing in toxicology, this new editorial claims to "respond to the invitation of the Commission's invitation."
Helmut Greim, "corresponding author" of the text and retired professor of toxicology from the Technical University of Munich (Germany), told Le Monde this invitation came on November 8, 2019, when the European Commission held its "first annual forum on endocrine disruptors" in Brussels
"The Commission representatives encouraged the attendees to present written comments."
Which they did.
This editorial's timing seems politically charged: The EU executive has been questioning its regulation of chemicals and EDCs for several months now. EDCs are only addressed in the pesticides and biocides (pesticides for domestic use) law, with measures in place since only 2018. The presence of EDCs in the environment and in a wide range of consumer goods (plastics, toys, cosmetics, food packaging, hospital equipment etc.) has yet to be regulated.
Several procedures were initiated in 2019 and 2020. These "fitness checks" and "stakeholder" consultations should enable the Commission to take stock of the regulations in place. Is there room for improvement? Should the provisions be tightened?
The atmosphere is not favorable for being lax. The Commission promised to "minimise exposures of EU citizens to endocrine disrupters beyond pesticides and biocides" when it announced in 2017 that it would prepare a comprehensive "new strategy" on EDCs.
Then, at the end of 2019, the President of the EU, Ursula von der Leyen, herself a doctor, committed in her political guidelines to "protect citizens' health from environmental degradation and pollution, addressing air and water quality, hazardous chemicals, industrial emissions, pesticides and endocrine disruptors."
On June 25, the European Parliament's Environment Committee is due to make its contribution to the debate before a plenary vote in July. Expected in September, the Commission's announcements will be part of the Green Deal, which is a set of policy initiatives aiming at making Europe climate neutral in 2050.
Helmut Greim, German scientist and corresponding author of the new editorial. (Credit: ARD.de/YouTube)
"Out-of-date and one-sided"
Scientific evidence on EDCs and their broad-spectrum harmfulness has been accumulating for almost 30 years. Yet the signatories of the April 2020 editorial, who call themselves "prominent experts and scientific leaders in the field," consider that synthetic EDCs are no more dangerous than "natural" EDCs found in "soy-based diets, green tea and sweet mustard."
Without any scientific reference to support their assertion, they claim that exposure to "synthetic" EDCs "has continuously declined over the past five decades while exposure to [natural] EDCs has increased…primarily in conjunction with an increase in vegetarian lifestyles."
The authors also contest the existence of effects caused by exposure to EDCs at low doses. This is, however, a characteristic of these substances: they hack into the body's circuitry at doses as small as those of natural hormones.
In conclusion, the authors suggest halting all research on the effects of EDCs on laboratory animals and to limit them to in vitro tests, that is on cultured cells, and not entire living organisms.
To substantiate their statements, the toxicologists refer to old studies. Many studies date from the early 2000s, before most of the research on EDCs was even conducted. There is no mention of the regulatory measures adopted by the EU since 2009. Authors also practice self-citation, building their arguments from their own publications, mostly similar editorials or letters sent to journals to challenge research unfavorable to EDCs. Finally, the references contain a significant number of articles written by consultants on behalf of industry.
The scientific content is "out-of-date and one-sided," said Linda Birnbaum, a toxicologist who worked as a government scientist in the U.S. for four decades, one of them as head of the National Institute of Environmental Health Sciences (NIEHS).
When asked if the work of those authors counts in the EDC field, she answered: "Not to unbiased researchers."
The text is severely criticized by the Endocrine Society, the main society in the field comprised of 18,000 doctors and researchers. "The editorial disregards the large body of evidence linking endocrine-disrupting chemical exposure to public health harms," said Barbara Demeneix, Chair of the Society's Endocrine-Disrupting Chemicals Advisory Group.
An expert group convened by the Endocrine Society in 2015 to elaborate a reference document reviewed more than 1,500 studies and concluded that there was "robust scientific evidence from animal, human, mechanistic and epidemiological studies" to establish "strong links between EDC exposure and health impacts ranging from obesity, diabetes and hormone-sensitive cancers to adverse effects on neurodevelopment, reproductive health and the thyroid gland."
However, in an email to Le Monde, Helmut Greim argued that "due to the very low exposures und [sic] potencies of the so called synthetic EDCs there is no plausibility that they cause a problem. Since a statement of a single individual can always be questioned an editorial by renown [sic] and independent scientists…most convincing," he wrote.
Tufts University biologist Ana Soto. They are "self-proclaimed experts with no expertise," she said of the authors of the new editorial. (Credit: Antoine Doyen/Tufts.edu)
At Tufts University, near Boston, biologist Ana Soto is exasperated by this constant questioning of the validity of the EDC issue which she, along with other pioneers, identified as early as 1991. "I'm tired of this," she said with a sigh.
Soto mobilized a researcher from her team for Le Monde who sifted through the actual scientific work of these 20 or so scientists on the subject of EDCs.
The researcher, Victoria Bouffard, analyzed their publications in the scientific literature. Her preliminary results show that the terms "endocrine," "estrogen," "androgen," "thyroid," or "bisphenol A" very rarely appear in their articles. And for many, only in commentaries, letters or editorials, not in research articles or reviews.
"To throw an editorial, you don't need a lot of work," said Ana Soto.
Frequently solicited in Brussels in recent years, Daniel Dietrich (University of Konstanz, Germany), for example, only counts 12 publications out of 45 containing these terms – "not enough to be an EDC expert," said Soto. In the last three years, Wolfgang Dekant (University of Würzburg, Germany) had only 12 publications: three editorials, three industry-sponsoredstudies, and the other six are the April editorial published six times. Finnish nanotechnology specialist Kai Savolainen has none.
They are "self-proclaimed experts with no expertise," concluded Soto.
While the authentic EDC specialists publish in well-respected journals – from the specialist Environmental Health Perspectives to the famous Lancet – this small, all-male brigade attacks their work in minor toxicology journals, most of which they edit themselves.
"Frankly, I find it inexcusable that the same commentary can be published in  different journals – I think an author of the commentary is an editor of each journal in question," said Linda Birnbaum.
Sign at European Parliament. (Credit: Stéphane Horel)
Conflicts of interest
What could possibly be the motives of scientists who have worked all their lives on the toxicity of chemicals to deny their very effects and beg the authorities not to provide more protection for the population?
Perhaps the beginning of the answer lies in their conflicts of interest. This point is of particular concern for Barabara Demeneix who, on behalf of the Endocrine Society, "would be interested in seeing more detailed information about the authors' disclosures to ensure that readers are aware of all relevant potential conflicts."
At the bottom of the editorial, the authors solemnly declare "that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper." Le Monde's systematic research into their collaborations, over the last three years, with industries whose products are threatened by EDC regulations shows it is far from being the case.
Retired since 2002, Helmut Greim was a consultant for Sumitomo in 2019, as indicated in the declaration of interest of an article about a pesticide that he co-authored with employees of the Japanese chemical firm. The same year, he was on a panel for the American Chemistry Council, the U.S. chemical industry's lobbying organization. Since 2001, he has been a member of the scientific committee of Ecetoc, the European scientific think tank of the chemical industry.
Also of note, Greim was a member of the expert panel established in 2015 by Monsanto to defend its controversial herbicide glyphosate and was involved in a ghostwriting case. As revealed by Le Mondewhile exploring the "Monsanto Papers," he had signed a scientific article mostly written by the company's toxicologists.
Greim also became a kind of world celebrity in 2018, when the press dubbed him "Monkeygate Doctor." He was an advisor to a German automobile manufacturers' association and gave the go-ahead for an experiment in which monkeys were exposed to diesel exhaust. Alongside this type of activity, he also held important responsibilities in various official European scientific committees for almost three decades.
But their editorial, said Greim, "is merely science based." "I hope that in your Le Monde article you will discuss science and not whether one or the other of the authors has worked with industry."
Has this text been commissioned? Does he have any comment on the fact that half of the authors – including himself – have not declared their conflicts of interest? Helmut Greim did not answer these questions.
Among the nine signatories with industry connections over the past three years, Alan Boobis is well known in the regulatory toxicology community. Recently retired from Imperial College London, he declared three months ago that he was "a member of several scientific advisory boards," stating that "none of these collaborative activities is or was remunerated."
At the request of Le Monde, he provided the list. They include the Centre for Research on Ingredient Safety (CRIS, notably funded by Bayer, Hershey's and PepsiCo), the Long Range Science Strategy (LRSS) of Cosmetics Europe, the European lobbying organization of the cosmetics sector, and the medical device manufacturer Owlstone Medical.
Also on a pro bono basis, Mr. Boobis has been a member of the Board of Trustees of ILSI, the leading scientific lobbying organization for the pesticide, biotechnology and food industry, for many years. As none of these positions are compensated, "there was considered to be no conflict influencing the work of the paper and hence no declaration," explained Alan Boobis.
Sir Colin Berry, who co-authored the Sumitomo study mentioned above with Helmut Greim, himself stated on the website of the British Science Media Centre to be a consultant for BASF, Bayer, DuPont, Monsanto and "a number of pharmaceutical companies," and an advisor to the European Risk Forum.
Funded by companies such as BASF, Bayer and Chevron, this Brussels think tank aims to extract the precautionary principle from official European texts and concerns. Also retired for many years, Mr. Berry said he chairs Syngenta's "ethics committee," which usually pays him through "hourly fees."
Since 2013 at least, Canadian Sam Kacew (University of Ottawa) has been a permanent member of the Scientific Advisory Board of the North American Flame Retardant Alliance (Nafra), a sub-section of the American Chemistry Council, which advocates for those chemicals that are toxic to the brain and the reproductive system. For this mission, he stated that he has received honoraria in the lastthreeyears. Mr. Berry and Mr. Kacew did not answer questions from Le Monde.
Christopher Borgert's relationship with industry is more direct. A self-employed consultant, his clients since 2018 have included Monsanto, CropLife America (pesticides), the American Chemistry Council, the Endocrine Policy Forum (the alliance of the last two), and an industry consortium that defends benzene.
While Le Monde has investigated only the last three years, some of these scientists have a very longstanding relationship with industry. Aged 89, Gio Batta Gori, for example, is part of the furnishings of this small world. A former tobacco industry consultant, he was for many years editor of Regulatory Toxicology and Pharmacology, a journal remotely controlled by industry, publishing articles complaisant to toxic products.
Born in 1938, Hans Marquardt was a member of the scientific advisory board of Philip Morris' "external research programme" in the early 2000s, as evidenced by contracts and correspondence in the "Cigarette Papers," the secret archives of the tobacco companies.
In total, at least 15 of these 19 scientists have had ties with the chemical, pesticide, fossil fuel or tobacco industries over the course of their careers.
Outside of the Berlaymont building, headquarters of the EU Commission in Brussels (Credit: Stéphane Horel)
Getting the ear of EU decision-makers
Some of them are not at their first "hit." As early as June 2013, seven of them had already signed a shorter editorial, then published in 14 journals. The initiative came from the Germans Helmut Greim, Wolfgang Dekant and Daniel Dietrich.
Coupled with an intervention directed at the highest scientific authorities of the Commission, the text had played a major role in derailing the decision-making process on the EDC regulation, which was then in the process of being elaborated. Solicited at the time by the EU, toxicologist Andreas Kortenkamp (Brunel University, London) does not hide his feeling of "déjà vu."
Even if their objective seems "less clear" to him, today, as in the past, these authors have the "possibility to create an impact on politicians who are not intimately familiar with the subject matter," he said to Le Monde. To him, this initiative amounts to "pseudo-scientific advice leading to bad political decisions."
Despite their incompetence on the subject and their known connections with industries threatened by the progress of chemicals regulation worldwide, the hard core of these scientists manages to get the attention of EU decision-makers. In May 2016, they were even received by the Commissioner for Health, Vytenis Andriukaitis, at a meeting more akin to lobbying than scientific advice.
Over the course of these meetings, editorials and articles, this small group has managed to create the illusion, in Brussels and elsewhere, of a deep scientific disagreement on the issue of the EDCs.
The "controversy" is artificially inflated by only a handful of individuals with little real experience in the science of endocrine disruption. Since 2013, eight members of this core group have published at least six editorials in the toxicology journals they edit. All of them minimize the problem of EDCs, or their own conflicts of interest, which are never declared. Most of them are relayed, or even openly supported, by lobby groups.
In 2016 alone, they attacked the "pseudo-science" of EDC research twice. "Free societies would be hard pressed to tolerate regulations that cause massive economic misallocations and pervasive public anxieties," lambasted another editorial. Daniel Dietrich, finally, called EDCs an "urban legend" in an article calling on Sigmund Freud to address their impact on male genitalia.
Jan Hengstler (Technical University of Dortmund, Germany), a liver specialist, has for his part no conflict of interest. A signatory to four of these texts, he claimed authorship of a parody note on the subject of EDCs in July 2019.
Signed "I. M. Portant and R. E. Sults" (for "important" and "results") of the "Awkward Medical School," the article mocked 20 years of research on the low-dose effects of EDCs. Reporting the "below zero" effects of an imaginary endocrine disruptor called "hypochondriazole", the real authors recommended "an immediate ban on all types of chemical entities."
And they ended with these words: "The authors declare that they have conflicts but no interests."
A humor for specialists, which is precisely not to the taste of the specialists.
"Low-dose effects are real," said Linda Birnbaum. "Much of the supposedly satirical commentary just shows their level of ignorance."
The April 2020 editorial does no better, according to Barbara Demeneix, who said it "does not reflect the well-established scientific evidence justifying the urgent need to reduce exposure to EDCs. Delaying science-based regulatory controls will affect the health of current and future generations and ecosystems globally."
Stéphane Horel and Stéphane Foucart are journalists at Le Monde.
Banner photo: The Berlaymont building, headquarters of the EU Commission in Brussels (Credit: Stéphane Horel)