Laboratory rats. Photo: niderlander / Shutterstock.com.
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Scientific journal retracts study exposing GM cancer risk
F. William Engdahl
5th December 2013
The Journal of Food and Chemical Toxicology appears to have violated scientific standards by withdrawing a study which found that rats fed on a Monsanto GM corn were more likely to develop cancer than controls. William Engdahl investigates.
Is this part of an attempt by Monsanto and the life science industry to seize control of science?
Stringent criteria exist for a serious scientific journal to accept a peer-reviewed paper and to publish it. Strict criteria are also defined according to which an article can be withdrawn after publication.
The Journal of Food and Chemical Toxicology has apparently decided to violate those procedures, announcing that it is retracting a long-term study, published a year ago, on the toxic effects of NK603 - a genetically modified (GM) variety of maize owned by the biotechnology and agrochemical giant Monsanto.
In its November, 2012 issue, the Journal of Food and Chemical Toxicology published a paper titled 'Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize' by Gilles-Eric Séralini and his team of researchers at France's Caen University.
It was a highly important study as it was the first and, astonishingly, still the only long-term study under controlled conditions of possible effects of a diet of GM maize treated with Monsanto's Roundup herbicide.
Séralini submitted his study results to the respected Journal following a rigorous four-month review by scientific peers regarding methodology, experimental design and other criteria. Seralini's group tested more than 200 rats of a diet of GMO corn over a period of a full two years, at a cost of € 3 million. The study was done in absolute secrecy to avoid industry pressure.
The publication created an atomic blast rocking the entire edifice of the GMO industry. Pictures of test rats with grotesque cancer tumors appeared in newspapers around the world.
Séralini's group studied the effect of a Monsanto GM maize diet on the rats for much longer than Monsanto had done in their study submitted to the EU European Food Safety Authority (EFSA) for approval. The group conducted its study for the full two-year average lifetime instead of just 90 days, as in the Monsanto study.
The long-term span proved critical. The first tumors only appeared four to seven months into the study. In the industry's earlier 90-day study on the same GMO maize Monsanto NK603, signs of toxicity were seen, but were dismissed as "not biologically meaningful" by industry and EFSA alike. It now appears that those results were very biologically meaningful indeed.
Séralini's later study was carried out with the highest number of rats ever measured in a standard GMO diet study. The team also tested "for the first time three doses (rather than two in the usual 90 day long protocols) of the Roundup-tolerant NK603 GMO maize alone, the GMO maize treated with Roundup, and Roundup alone at very low environmentally relevant doses starting below the range of levels permitted by regulatory authorities in drinking water and in GM feed."
Their findings were more than alarming. The Séralini study concluded:
"In females, all treated groups died two to three times more than controls, and more rapidly. This difference was visible in three male groups fed GMOs. All results were hormone and sex dependent, and the pathological profiles were comparable. Females developed large mammary tumors almost always more often than and before controls; the pituitary was the second-most disabled organ; the sex hormonal balance was modified by GMO and Roundup treatments.
"In treated males, liver congestions and necrosis were 2.5 - 5.5 times higher. This pathology was confirmed by optic and transmission electron microscopy. Marked and severe kidney nephropathies were also generally 1.3 - 2.3 greater. Males presented 4 times more large palpable tumors than controls ... ".
Monsanto on the defensive
Monsanto and the related GMO industry immediately went on a war footing to control the potentially fatal damage from the Séralini study. Suddenly, with worldwide attention on the Séralini results, the EU Commission and its EFSA were under fire as never before in their history.
Their reaction was worthy of a bad Agatha Christie murder novel. They piously announced that they had passed the Séralini study on to their EFSA scientific panel for evaluation.
The Brussels-based EU scientific food regulatory organization, EFSA, was under fire following the damning results of the long-term Séralini study. EFSA had recommended approval of Monsanto's NK603 Roundup-tolerant maize in 2009 without first conducting any independent testing. It admitted it had relied on"information supplied by the applicant [Monsanto]."
EFSA also admitted that the Monsanto tests on rats were for only 90 days. Séralini's group noted that the massive toxic effects and deaths of GMO-fed rats took place well after 90 days, one reason longer-term studied were obviously warranted.
EFSA concluded at the time of its initial Monsanto NK603 approval in 2009 that, "data provided [by Monsanto] are sufficient and do not raise a safety concern." The Brussels-based body added:
"The EFSA GMO Panel is of the opinion that maize NK603 is as safe as conventional maize. Maize NK603 and derived products are unlikely to have any adverse effect on human and animal health in the context of the intended uses."
But now the Séralini study suddenly called into question the safety of Monsanto's NK603 maize - and in the process cast grave doubt over the EFSA, and the entire regulatory control process for GMO foods.
The EU Commission was already on record stating that no independent non-GMO industry long-term studies were needed on animals to test their safety. The EU guidelines for testing stated:
"Toxicological assessments on test animals are not explicitly required for the approval of a new food in the EU or the US. Independent experts have decided that in some cases, chemical analyses of the food's makeup are enough to indicate that the new GMO is substantially equivalent to its traditional counterpart ...
"In recent years, biotech companies have tested their transgenic products (maize, soy, tomato) before introducing them to the market on several different animals over the course of up to 90 days. Negative effects have not yet been observed."
The key words are "up to 90 days". Séralini's study only observed serious tumors and other effects after 120 days in their two-year study.
On November 28, 2012, only a few weeks after the study was published, EFSA in Brussels issued a press release with the following conclusion:
"Serious defects in the design and methodology of a paper by Séralini et al mean it does not meet acceptable scientific standards and there is no need to re-examine previous safety evaluations of genetically modified maize NK603."
Per Bergman, who led EFSA's work on NK603, argued that Seralini had used the wrong kind of rats; not enough rats; and that the statistical analysis was inadequate. He said:
"EFSA's analysis has shown that deficiencies in the Séralini et al. paper mean it is of insufficient scientific quality for risk assessment. We believe the completion of this evaluation process has brought clarity to the issue."
But judged by Bergman's standards, all toxicity studies on glyphosate and GMOs should be retracted - because they used the same type and approximate number of rats as those in the Séralini study.
At the very least, the 'precautionary principle' that applies where there is a potential for severe health damage to the human population would mandate that the EU Commission and its EFSA should order immediate further serious, independent long-term studies to prove or disprove the results of the Séralini tests.
The EFSA's refusal to re-examine its earlier decision to approve Monsanto GMO maize - no matter what flaws might or might not have been in the Séralini study - suggested that the regulator was trying to cover up for the GMO agrichemical lobby.
Many members of the EFSA GMO review panel had documented ties to Monsanto and the GMO industry, apparently creating serious conflicts of interest. Corporate Europe Observer, an independent EU corporate watchdog group, noted about the EFSA response:
"EFSA failed to properly and transparently appoint a panel of scientists beyond any suspicion of conflicts of interest; and it failed to appreciate that meeting with Europe's largest biotech industry lobby group to discuss GMO risk assessment guidelines in the very middle of a EU review undermines its credibility."
New blood at Elsevier
The official EFSA statement seemed to take the pressure off Monsanto. But so long as the Séralini study remained in the Elsevier Journal, it would maintain its scientific credibility - and continue to circulate and be cited by other scientists around the world.
Then out of the blue, in May 2013, six months after the Séralini study release, Elsevier announced that it had created a new position, that of 'Associate Editor for Biotechnology'. The person they hired to fill it was Richard E. Goodman. A former Monsanto employee, Goodman was also employed by the industry-funced (including by Monsanto) pro-GMO lobby organization, the International Life Sciences Institute (ILSI).
Anti-GM campaigners say that ILSI's main role is to develop industry-friendly risk assessment methods for GM foods and chemical food contaminants, and work in regulation-making bodies to insert them into government and transnational regulations.
As one critical scientific website posed the obvious ethical sham of hiring Monsanto people to control GMO publications: "Does Monsanto now effectively decide which papers on biotechnology are published in FCT? And is this part of an attempt by Monsanto and the life science industry to seize control of science?"
Séralini paper retracted
Then on November 24, 2013, six months after Goodman took control of GMO issues at the Journal, Dr. A. Wallace Hayes, the editor of the Journal of Food and Chemical Toxicology, retracted the study by the team of Professor Séralini. In his statement announcing the retraction he wrote:
"Unequivocally, the Editor-in-Chief found no evidence of fraud or intentional misrepresentation of the data. However, there is legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected.
"The low number of animals had been identified as a cause for concern during the initial review process, but the peer-review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence.
"Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups.
"Ultimately, the results presented (while not incorrect) are inconclusive, and therefore do not reach the threshold of publication for Food and Chemical Toxicology."
However these reasons for the extraordinary retraction a full year after publishing violate the guidelines for retractions in scientific publishing set out by the Committee on Publication Ethics (COPE), of which FCT is a member. According to the guidelines, the only grounds for a Journal to retract a paper are:
- Clear evidence that the findings are unreliable due to misconduct (e.g. data fabrication) or honest error;
- Plagiarism or redundant publication;
- Unethical research.
Séralini's paper meets none of these criteria and Hayes admits as much. In his letter informing the professor of his decision, Hayes concedes that examination of Séralini's raw data showed no evidence of fraud or intentional misrepresentation of the data. As Claire Robinson of GM Watch points out:
"Inconclusiveness of findings is not a valid ground for retraction. Numerous published scientific papers contain inconclusive findings, which are often mixed in with findings that can be presented with more certainty. It is for future researchers to build on the findings and refine scientific understanding of any uncertainties."
Elsevier's fake journals
Elsevier, the publisher of the Journal of Food and Chemical Toxicology, is one of the giants in worldwide scientific publications. And they are apparently not so rigorous over scientific principle when it comes to making money.
In 2009, Elsevier invented an entire medical journal, the 'Australasian Journal of Bone and Joint Medicine', complete with editorial board, in order to publish papers promoting the products of the pharmaceutical manufacturer Merck.
Merck provided the papers, Elsevier published them, and doctors read them, unaware that the Australasian Journal of Bone and Joint Medicine was simply a PR vehicle for the drug giant Merck. It later emerged that the AJBJM was just one of six such industry-sponsored Elsevier publications masquerading as peer-reviewed scientific journals.
Science itself at risk from corporate influence
In his statement on the Séralini retraction, Wallace Hayes expressed his thoughts over the peer-review process: "The peer-review process is not perfect, but it does work. The journal is committed to a fair, thorough, and timely peer-review process; sometimes expediency might be sacrificed in order to be as thorough as possible. The time-consuming nature is, at times, required in fairness to both the authors and readers."
But the real question here is the independence and scientific impartiality of the peer-reviewed journals, with their crucial role at the heart of the scientific process. The Séralini case suggests that they, and the publishing companies that own them, may be susceptible to undue influence from corporate behemoths. Human health - and the integrity of the scientific process itself - are under serious threat.
Photo courtesy of Shutterstock.
See the Open Letter in which over 100 scientists pledge to boycott Elsevier over the Séralini retraction.
See also "Deformities, sickness and livestock deaths: the real cost of GM animal feed?", published in The Ecologist.
William F Engdahl is an award-winning geopolitical analyst and strategic risk consultant whose internationally best-selling books have been translated into thirteen foreign languages.
He is author of Seeds of Destruction: The Hidden Agenda of Genetic Manipulation, and other books. Further information at www.williamengdahl.com.
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