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Thursday 23 March 2017

Update: After quick review, medical school says no evidence Monsanto ghostwrote professor's paper

http://www.sciencemag.org/news/2017/03/medical-school-examine-whether-professor-published-paper-partly-written-chemicalUpdate: After quick review, medical school says no evidence Monsanto ghostwrote professor's paper
After a quick investigation, officials at a medical school in New York State say they have found "no evidence" that a faculty member violated the school's prohibition against authoring a paper ghostwritten by others. The statement came one day after ScienceInsider reported that New York Medical College (NYMC) in Valhalla, New York, would examine a researcher who, according to internal documents released last week by a federal court in California, put his name on a 2000 paper partially ghostwritten by employees at Monsanto, the giant agricultural chemicals company based in St. Louis, Missouri. An NYMC spokesperson declined to provide details of how it conducted its investigation, saying in a statement that NYMC "does not disclose details of its internal investigations, but the college does consider the matter in question to be closed."
At issue is a 2000 paper published in the journal Regulatory Toxicology and Pharmacology.  It concluded that a review of studies of one of Monsanto’s most successful products, the widely-used herbicide Roundup, showed no evidence of harmful effects on people.The lead author on the paper is Gary Williams, a pathologist at NYMC. His last name appears briefly in documents unsealed last week as part of a lawsuit against Monsanto by people alleging they developed non-Hodgkin’s lymphoma from exposure to Roundup and its primary ingredient, glyphosate.
The documents, including internal emails written in 2015, reveal Monsanto executives strategizing about ways to work with academic and independent scientists to get out the company’s message that glyphosate poses no risk of cancer. And they include suggestions that company officials “ghost write” portions of scientific papers to be submitted to peer-reviewed technical journals.



NYMC learned of the court documents as a result of an inquiry by ScienceInsider, and a public affairs representative said the school would look into the matter. Claiming authorship for work done by others is considered to be a serious ethical breach in the research community, as is not disclosing potential conflicts of interest.

Vigorous defense

The documents provide a window into Monsanto’s efforts to mount a vigorous defense of Roundup’s safety after an international panel concluded in 2015 that glyphosate was a probable human carcinogen. That finding, issued by the International Agency for Research on Cancer (IARC), a branch of the World Health Organization based in Lyon, France, helped fuel a long-running controversy surrounding glyphosate.
The science around the chemical remains unsettled. Though IARC has raised concerns, a number of regulatory agencies have declared they see no evidence that glyphosate causes cancer. The European Chemicals Agency declared last week that the chemical should not be classified as a carcinogen.
Monsanto officials had learned in advance of IARC’s 2015 decision, and considered responses aimed at quickly pushing back against the agency’s findings, according to emails among company executives. Several options involved seeking to publish papers in scientific journals buttressing the company’s contention that the chemical didn’t pose a health risk to people. That included sponsoring a wide-ranging paper that, according to an email from one company executive, could cost more than $250,000 to produce.
In one email, William Heydens, a Monsanto executive, weighed in on that option, suggesting Monsanto could cut costs by recruiting experts in some areas, but then “ghost write” parts of the paper. “An option would be to add Greim and Kier or Kirkland to have their names on the publication, but we would be keeping the cost down by us doing the writing and they would just sign their names so to speak. Recall this is how we handled Williams Kroes & Munro 2000,” Heydens wrote in an email. (See p. 203 of this PDF.)
The lead author on “Williams Kroes & Munro 2000” was NYMC’s Gary Williams, an M.D. whose “research interests include mechanisms of carcinogenesis” and the “metabolic and genetic effects of chemical carcinogens,” according to a university website. Williams did not respond to an email from ScienceInsider seeking comment. His two co-authors, Robert Kroes and Ian Munro, have died, according to media reports. The journal’s editor, Gio Gori, a former National Institutes of Health researcher who drew attention in the 1980s for accepting funding from the tobacco industry and questioning the risks posed by second-hand smoke, could not be reached.
Another researcher mentioned in the email, David Kirkland, a genetic toxicologist based in Tadcaster, U.K., was a co-author on a 2016 paper with Williams and several others. That paper, which appeared in the journal Critical Reviews in Toxicology, reviewed the IARC findings and concluded the scientific research didn’t support claims that glyphosate posed a risk of genetic toxicity. He is adamant that  the paper was not ghostwritten. "I’ve been in the field for 35 years. I’ve got a global reputation,” he told ScienceInsider. “I'm not about to try and compromise that by signing up to a paper that has been ghostwritten by someone else.”
Kirkland, who works as a private consultant, has served as a consultant for Monsanto on a glyphosate task force in Europe, and Monsanto provided the funding behind the 2016 study, according to disclosures accompanying the paper. Kirkland also co-wrote a 2013 paper reviewing research around the health effects of glyphosate, under a contract with the Glyphosate Task Force, an industry-backed group, he says. But Kirkland says the money’s source didn’t influence his findings. “I make my judgements based on the science and not on any particular stakeholder,” he says.
A top Monsanto executive echoes Kirkland, stating that Monsanto employees did not write any portions of either the 2000 or 2016 papers. Rather, Scott Partridge, Monsanto’s vice president of global strategy, says Monsanto scientists will work with outside scientists to help them access research data and other scientific information held by the company.  “There was nothing secret or hidden or underhanded here. What I regret is the unfortunate use of the words ‘ghostwriting.’ That’s an inappropriate way to refer to the collaborative scientific engagement that went on here,” Partridge says.

Part of a pattern?

But Pearl Robertson, a New York City–based attorney representing some of the plaintiffs suing Monsanto, says the cozy relationship is part of a pattern marked by Monsanto trying to shape the science around glyphosate. She points to a 1999 email in which Heydens, the Monsanto executive, refers to whether the company should continue working with Dr. James Parry, a genetic toxicologist at the Swansea University in the United Kingdom, who has since died. “Let's step back and look at what we are really trying to achieve here,” Heydens writes. “We want to find/develop someone who is comfortable with the genetox profile of glyphosate/Roundup and who can be influential with regulators and Scientific Outreach operations when genetox. issues arise. My read is that Parry is not currently such a person, and it would take quite some time and $$$/studies to get him there.”
Taken together, Robertson says, the internal documents show how Monsanto “perpetually” tries to control “the science and scientific literature that is seen by the public as a whole and by regulatory agencies such as the [Environmental Protection Agency].”
Monsanto’s Partridge, however, says the discussions simply reflect the company’s interest in finding scientists who are already familiar with the full range of scientific research on glyphosate and Roundup. “We didn’t want to hire somebody who would propose doing new and additional studies that we believe weren’t necessary,” he says.
Sheldon Krimsky, a professor at Tufts University in Medford, Massachusetts, who has written about ghostwriting, says the practice has been an issue in other fields, particularly in the pharmaceutical industry. Hiding the real authors of a paper is forbidden at most journals, he notes, adding that transparency “is what gives science its integrity. And when you violate that, there’s deception,” says Krimsky, a former chair of the Committee on Scientific Freedom and Responsibility at the American Association for the Advancement of Science (which publishes Science). “The last thing we need in science in this day and age is deception.”