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Translate PDF. 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.
Keywords: carcinogenicity, conflicts of interest, ghostwriting, genotoxicity, glyphosate, herbicides, Intertek, key opinion leaders, Monsanto, non-Hodgkins lymphoma, third parties, Roundup. The best-laid schemes o' mice an' men Gang aft agley. Introduction Corporate misrepresentation of scientific testing facilitated by third-party academic consultants is now well documented in medicine [1, 2, 3]. The crucial components of the third-party strategy include ghostwriting, the creation of decoy research, marketing spin and public relations campaigns designed to discredit and intimidate critics.
In other cases, they undermine the work of scientists who persist in conducting research that runs contrary to their goals [4, p. Industry-contaminated science has alarming consequences for public health as misrepresentations pass through the system undetected by regulatory agencies and the courts that rely on evidence-based results. Email: leemon. Examples from recent cases include: addiction, iatrogenic illness, birth defects, drug-induced suicide, congestive heart failure, stroke, heart attack and botched surgeries involving faulty medical devices [6, 2, 7].
The purpose of this article is to evaluate the impact of the third-party strategy beyond the pharmaceutical and medical device industries. In this case study from on-going litigation I examine the efforts of agrochemical giant Monsanto to influence the reporting of scientific results related to the safety of the herbicide Roundup, and its active chemical, glyphosate.
This article will not offer an opinion about any particular study concerning the safety of Roundup or glyphosate as that project is beyond the scope of this paper and requires expertise in each of the various areas of scientific investigation.
The documents include: internal Monsanto emails, manuscript drafts, peer review reports, deposition testimony, powerpoint presentations and text messages. This request was denied. IARC Controversy Over Glyphosate Glyphosate N- phosphonomethyl glycine was first used as a descaling agent for cleaning mineral deposits in industrial boilers and pipes. Monsanto then developed the molecule in the early s as an herbicide.
Until recently, it has been considered safe for use on crops, lawns and gardens. Unlike most other important chemicals, pesticides are designed to impact living systems …Consequently there has long been a concern about environmental and human consequences of widespread pesticide use [9, p. In , an international advisory group of senior scientists and government officials recommended dozens of pesticides for evaluation, which included glyphosate.
This conclusion was also based on strong evidence from mechanistic data that glyphosate causes genotoxicity and oxidative stress [10, pp. Manufacturing Doubt: Ghostwriting the Reports Since articles written by industry employees may be considered to have little credibility, for-profit industries rely on third parties to give their publications the appearance of an independent, objective, scientific assessment and thereby increase the likelihood of acceptance by the relevant journals.
Ghost authorship is the failure to name, as an author, an individual, typically an employee of a pharmaceutical company or medical communication firm, who has made substantial contributions to the research or writing of the article [17, p. Ghostwriting toxicology publications for glyphosate sponsored by Monsanto indicates the practice might be more widespread than previously suspected.
It was noted that this would be more powerful if authored by non-Monsanto scientists e. What the released documents demonstrate is that the Expert Panel was anything but an independent collection of neutral scientists rendering an opinion on the carcinogenicity of glyphosate. The attached draft manuscript shows that Heydens made substantial edits, some of which overruled what named authors had deleted as inflammatory of IARC, and marginalia comments that demonstrated that he controlled the manuscript.
In neither the Acknowledgements nor the Declaration of Interest in the Williams et al. Since Heydens is not included as an author in the by-line of the published article, he qualifies as a corporate ghost author. What the documents do not reveal, however, is to what degree the sixteen named authors on the article qualify for genuine authorship.
The question of the ethical permissibility of ghostwriting arose when, in the course of assigning authorship, a member of the Expert Panel and former Monsanto employee, John Acquavella, was excluded from a poster planned for a SRA [Society for Risk Analysis] meeting. We call that ghost writing and it is unethical. In this email, Acquavella inserted the International Committee of Medical Journal Editors ICJME Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which states: Authorship credit should be based on 1 substantial contributions and design, acquisition of data, or analysis and interpretation of data; 2 drafting the article or revising it critically for important intellectual content; 3 final approval of the version to be published and 4 agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Authors should meet conditions 1, 2 and 3 and 4 … All persons designated as authors should qualify for authorship and all those who qualify should be listed… [24]. Sachs wrote to Henry I. I have background and can provide information if needed.
The outcome is embargoed but will be communicated as early as next week. In the piece that appeared on Forbes. After seeing these documents posted among the Monsanto Papers, Forbes removed the article from its website and terminated its relationship with Miller for failing to disclose conflicts of interest and for publishing content that was not his own original writing.
The references to Greim, Kier and Kirkland in the emails above reveal the influential third-party voices giving credibility to the Monsanto-sponsored manuscripts. Monsanto had devised a manuscript clearance procedure that shows the manuscript is their intellectual property cleared by legal review for submission to a journal.
Kirkland was added to the project to help enhance credibility by having a renowned specialist in the area of genotoxicity. Williams et al. Aside from the deception involved in any one ghostwritten article, once published, these articles perpetuate misrepresentations well into the future by citing other ghostwritten articles.
A Monsanto toxicologist, Charles Healy, when asked by the editor of Cell Biology and Toxicology to peer review a manuscript that raised problems with glyphosate, inappropriately sent the manuscript to Monsanto employees and asked for their input. 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 [nitric oxide] levels more than Roundup after two weeks of treatment. In any case it was certainly a violation of the standards of peer review that Healy was credited with being the reviewer of record on a peer review report that was apparently ghostwritten by two others. It is questionable as to why a manuscript for review on the safety of Roundup and glyphosate was sent by the journal editor of Cell Biology and Toxicology to an employee of the manufacturer in the first place.
Wallace Hayes, who had the final authority to retract. Miller in the Forbes article [43]. Articles should be retracted only for serious errors that undermine the reliability of the data or results or for serious ethical lapses.
This raises even more problems for conflicts of interest with industry and the integrity of peer review. A consulting agreement between A. Goodman received research funding from agrochemical companies, including Monsanto, while he was an editor of Food and Chemical Toxicology [46, p. In connection with the publication of industry ghostwritten articles, there is always a question of whether journal editors are complicit in maintaining the status quo.
At the time that tobacco companies were fighting against increasing negative public opinion, lawsuits and the threat of government regulation, the industry began using third-party consultants to influence the perception of science in their favor and create doubt in damaging toxicology reports about the health effects of smoking [4, pp. In one of the earliest ghostwriting documents released from tobacco litigation, A.
Wallace Hayes who worked for the R. Reynolds Tobacco Company in the s, is the author of a memorandum that details a proposal for a ghost writing program that would publish studies from toxicological investigations.
The memorandum shows how ghostwritten articles would be reviewed by a panel at Reynolds prior to submission in Cancer Research or The Journal of the National Cancer Institute [49]. Tobacco companies such as R. Reynolds are credited with writing the playbook for spinning science subsequently adopted by pharmaceutical companies and the agrochemical industry [4, p.
Chassy and David Tribe. I believe that there is a path to a process that would better respond to scientific concerns and allegations.
I shared with Val [Giddings] yesterday. From my perspective the problem is one of expert engagement and that could be solved by paying experts to provide responses. You and I have discussed this in the past. That makes sense but there is more. The key will be keeping Monsanto in the background so as not to harm the credibility of the information [50].
Byrne, president of v-Fluence Interactive, a market research and software development firm, wrote: I suggest we work on the money for all of us first and quickly?
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