By Dan Goldstein (aka Dr. Dan)
Recently, a paper was released claiming three Monsanto corn varieties cause organ damage in mammals. This simply isn’t true.
In the current paper (de Vendomois et al., 2009) as with the prior publication (Seralini et al, 2007), Seralini and his colleagues use non-traditional statistical methods to reassess toxicology data from studies conducted with MON 863, MON 810 and NK603 corn varieties, and reach unsubstantiated conclusions.
It is important to note that several groups of scientists have gone over the study, and refute the claims.
- The French High Counsel on Biotechnology (HCB) has considered both the de Vendomois (2009) and Seralini (2007) papers and has found that these papers make no useful contribution to the safety assessment.
- The Food Standards Australia New Zealand (FSANZ) have also dismissed this study, stating, “Séralini and colleagues have distorted the toxicological significance of their results by placing undue emphasis on the statistical treatment of data, and failing to take other relevant factors into account.”
- The European Food Safety Authority (EFSA) also assessed the study and proclamed, “The GMO Panel
concludes that the authors’ claims, regarding new side effects indicating kidney and liver toxicity, are
not supported by the data provided in their paper.”
Statistical fluctuations occur commonly in any large study with many endpoints, and statistical significance alone does not determine when an observation can be translated into evidence of risk. Making this determination requires consideration of:
- dose-related trends (higher dose should produce greater effect)
- relationship to other findings such as abnormal organ appearance on pathology examinations
- the magnitude of the differences and the relationship of the findings to the normal range of values
- occurrence of a particular finding in both sexes (adjusting for known gender related differences in some tests)
When considered using proper statistical analysis in conjunction with these other criteria, the toxicology studies cited demonstrate no adverse effects of these products.
A more complete discussion of the issues related to this publication, as well as references to pertinent publications, is available on the Monsanto website: Monsanto Response: de Vendomois et al. 2009
Want to know more about how Monsanto seed gets tested and approved?
Dan is the Director of Medical Sciences and Outreach at Monsanto. He is a pediatrician, medical toxicologist, and clinical pharmacologist by training, and for the past 10 years his role at Monsanto has been devoted on human safety and health, with a focus on communications with the general public and with physicians, nutritionists, and other scientists both in the US and around the world. Dan received his undergraduate degree in Molecular Biology from the University of Wisconsin in 1976 and my MD degree from Johns Hopkins in 1981, followed by a residency in Pediatrics at Johns Hopkins and a fellowship in Clinical Pharmacology and Medical Toxicology at the University of Toronto. He is board certified by the American Boards of Pediatrics, Medical Toxicology, and Clinical Pharmacology, and by the Royal College of Physicians of Canada (Pediatrics).
Prior to Monsanto, Dan spent 10 years in private practice in Denver, Colorado, providing consultation in the area of Clinical, Occupational, Environmental and Forensic Toxicology. He joined Monsanto’s Medical Department in 1998, was appointed a Senior Science Fellow in 2002, and currently serves as Director of Medical Sciences and Outreach within Regulatory Affairs. Dr. Dan has been extensively involved in plant biotechnology, pesticide, and children’s environmental health issues, and served on the U.S. EPA’s Child Health Protection Advisory Committee, as a member of the EPA Science Advisory Board regarding the cancer risk assessment from early-life exposure to carcinogens, as an advisor to the NAFTA Commission for Environmental Cooperation regarding the development of international child health indicators, and as well as Board member for the American College of Medical Toxicology.