Health impacts are denied, project leaders have conflicts of interest with industry

Testbiotech has done a great job of exposing the dodgy goings-on around the EU-funded GRACE research project, in which MON810 maize was fed to rats for the short period of 90 days. Even in this short time, the GM maize did have impacts on the rats’ health, Testbiotech has shown – contrary to the claims of no adverse effect made in the paper published by the GRACE consortium of researchers.

Testbiotech has also shown that the researchers have conflicts of interest with industry, notably Monsanto and the industry-funded lobby group ILSI, as well as suspiciously close links with the editorial board of the journal that published the paper.

Now the GRACE consortium is trying to shut down the debate with Testbiotech (see item 1 below).

Worryingly, the GRACE project also carried out a one-year feeding trial with MON810, the results of which have not yet been published. Let’s hope they haven’t been buried.

In addition, the EU’s G-Twyst project, which is testing a GMO in a long-term (2-year) rat feeding trial, is interconnected with the GRACE project. We know that long-term feeding trials are far more likely to show unequivocal problems with GMOs and their associated pesticides than 90-day trials. So the spin and misinformation that characterises the GRACE 90-day trial could easily be magnified when it comes to reporting the results of the G-Twyst project.

Both the GRACE and G-Twyst feeding trials are intended to inform Europe’s GMO regulations, in terms of deciding what type of animal feeding trials are required or indeed whether they should be required at all. Millions of euros in taxpayer money have been spent on them. That they should become embroiled in controversy around conflicts of interest and flawed interpretation of results is a tragedy of the EU authorities’ own making.

1. GRACE tries to end feeding study debate
2. GRACE - The EU risk research project sold out to industry
—

1. GRACE tries to end feeding study debate

Testbiotech, 19 January 2015
http://www.testbiotech.org/en/node/1138

* EU project rejects further discussions with Testbiotech

After Testbiotech provided evidence of incorrect or insufficient statements regarding declaration of interests in the context of a publication on a feeding trial carried out under the GRACE project, the GRACE Consortium is now trying to put an end to the debate. According to a media release of 14 January 2015, GRACE no longer sees “any basis for continuing the debate with Testbiotech”. Their official excuse: Testbiotech refuses to take part in a discussion in a forum hosted by the journal Archives of Toxicology in which the controversial study was published. The media release was distributed by an agency called Genius, which also works for the biotech industry.

There is no mention in the media release that there are good reasons not to participate in this specific forum: According to Testbiotech research, there are very close affiliations between the journal Archives of Toxicology and the experts working in the GRACE project. The journal also has a history of close cooperation with industry. Testbiotech is concerned that under these circumstances the preconditions for a strict peer review, full transparency in declaration of interests and for further unbiased and open scientific discussions will not be met.

Testbiotech has called upon the EU Commission to take action to ensure the highest standards in scientific quality of the project. Furthermore, Testbiotech is of the opinion that the publication should be withdrawn and republished in another journal, but only after a strict peer review.
—

2. GRACE - The EU risk research project sold out to industry

Testbiotech, 9 Jan 2015
http://www.testbiotech.org/sites/default/files/GRACE_sold%20out%20to%20industry.pdf
[Full report at link above]

Summary

The overall objective of the EU project GRACE (GMO Risk Assessment and Communication of Evidence) is to look at the risks of genetically engineered plants. Once completed it is supposed to have a significant impact on future methods and criteria to be used in the risk assessment of genetically engineered plants before market authorisations. Therefore, it is essential that it employs the highest standards regarding conflicts of interest, credibility and scientific scrutiny.

Testbiotech has voiced criticism of the way the GRACE-Consortium has been put together. Some of the leading experts involved in GRACE have close affiliations to institutions such as ILSI (International Life Sciences Institute) and ISBR (International Society for Biosafety Research), which are funded completely or to a large extent by industry. There are even experts involved with GRACE who are contracted to work for companies such as Monsanto.

Testbiotech has also criticised the publication and the presentation of the results of the GRACE feeding trial with genetically engineered maize MON810 in the journal Archives of Toxicology.

Testbiotech has further:

* exposed flaws in the presentation of the results from feeding trials, especially in regard to total serum protein concentration and pancreas weight and the increase in blood glucose levels. Contrary to the claims made in the publication, the data from feeding trials do indeed give some indication of health impacts in rats fed with genetically engineered maize.

* shown there are major flaws in the declaration of interests. In particular, these concern affiliations with Monsanto, ILSI and ISBR.

* revealed close contacts between GRACE experts and the editorial board of the Archives of Toxicology.

* These findings give the impression that the journal was not chosen for publication because of scientific reasoning, but because of personal networks established within a dubious context.

* Testbiotech therefore questioned whether in this case the conditions for a rigorous and independent peer review had been met.

* found evidence that the journal Archives of Toxicology itself is far too closely connected to industry, for example, several editors have close ties to the tobacco industry.

The coordinator of the GRACE Consortiums, the chief-editor of the Archives of Toxicology and the EU Commission have all responded to the Testbiotech reports. In their responses, they neither contest the close affiliations between the editors of Archives of Toxicology and the corresponding author of the publication, nor make any comment on the close relationship of the journal with industry. They do, however, dispute other points relating to conflicts of interest, flaws in scientific standards and presentation of the results:

* The GRACE Consortium asserts that the results of the feeding study are reported correctly in the publication, and the scientific standards of the publication comply with required international standards.

* The Consortium sees no reason to withdraw the publication, but Testbiotech is welcome to send a comment to the Archives of Toxicology for publication.

* The Consortium believes that the ISBR should simply be seen as a scientific organisation and therefore no conflicts of interest can emerge from membership.

* The Consortium asserts that leading GRACE experts are not active within ILSI.

* The Consortium believes that it is not necessary to explicitly mention that US company Monsanto is amongst the clients of some GRACE experts.

* The editor-in-chief of Archives of Toxicology rejects any concerns that is influenced or funded by any interests of industry.

* The EU Commission states that the participation of industry within GRACE was intended from the beginning.

Testbiotech took a closer look at these statements and came to the following conclusions:

* the existing data from feeding trials do provide relevant indications for health impacts that were not, or at least not correctly, presented in the disputed publication.

* Testbiotech appreciates that the raw data has been made accessible. However, it is a matter of concern that there is a lack of independence amongst experts responsible for data collection and analysis.

* the public availability of the raw data cannot in any case be a ground for accepting insufficient peer review standards of the data before publication. Independent and comprehensive peer review standards have to be applied in order to compare the conclusions from the publication with the original data.

* the statements made by GRACE on conflicts of interest are not correct and/or strongly misleading.

* there are strong reasons to question the statement made by the editor-in-chief of the Archives of Toxicology saying that he was never influenced by interests of industry.

* Testbiotech will not accept the invitation to send a comment to the Archives of Toxicology for further discussion because the journal is in a difficult position to defend its own reputation and cannot be considered as a neutral platform.

* Testbiotech is of the opinion that the answer given by the Commission is without substance and partially misleading.

Testbiotech has urged the EU Commission several times to take action. Some of its recommendations are:

* given the importance of this study, Testbiotech recommends the retraction of the paper. Re-publication should only be considered under a rigorous peer review process and in a journal with a scientific reputation not tarnished by questionable cooperation with industry, and which is not impacted by any affiliations to the authors and has the highest standards regarding conflicts of interest.

* the EU Commission should ensure that the experts who participated in the peer review process before the publication are named.

* the whole GRACE-project and the interconnected EU Project G-TwYST should be subjected to thorough examination to avoid further conflicts of interest.

* plans to publish further results from GRACE or G-TwYST in the Archives of Toxicology have to be rejected.

* this case should be a starting point to assess and reorganise the current EU programs and infrastructures in the context of risk research organised by the EU Commission.