Genetically Modified Corn Study Reveals Health Damage and Cover-up
By Jeffrey M. Smith, author of Seeds of Deception
http://www.seedsofdeception.com/utility/showArticle/?objectID=221

When a German court ordered Monsanto to make public a controversial 90-day rat study on June 20, 2005, the data upheld claims by prominent scientists who said that animals fed the genetically modified (GM) corn developed extensive health effects in the blood, kidneys and liver and that humans eating the corn might be at risk. The 1,139 page research paper on Monsanto’s "Mon 863" variety also revealed that European regulators accepted the company’s assurances that their corn is safe, in spite of the unscientific and contradictory rationale that was used to dismiss significant problems. In addition, the study is so full of flaws and omissions, critics say it wouldn’t qualify for publication in most journals and yet it is the primary document used to evaluate the health impacts.

Mon 863 is genetically engineered to produce a form of a pesticide called bacillus thuringiensis or Bt, designed to attack a corn pest called the root worm. Rats fed Mon 863 developed several reactions, including those typically found with allergies (increased basophils), in response to infections, toxins and various diseases including cancer (increased lymphocytes and white blood cells), and in the presence of anemia (decreased reticulocyte count) and blood pressure problems (decreased kidney weights). There were also increased blood sugar levels, kidney inflammation, liver and kidney lesions, and other changes. According to top research biologist Arpad Pusztai, who was commissioned by the German government to evaluate the study in 2004, based on the evidence no one can say that Mon 863 will cause cancer or allergies or anything specific. The results are preliminary and must be followed-up to rule these out. He warns, however, "It is almost impossible to imagine that major lesions in important organs. . . . or changes in blood parameters. . . . that occurred in GM maize-fed rats, is incidental and due to simple biological variability."

French Professor Gilles-Eric Seralini, a molecular endocrinologist at the University of Caen, agrees that the results indicate a toxic reaction. Seralini is a member of two French government commissions that evaluate GM food, one of which originally rejected a request for approval of the corn variety in October, 2003 due to the adverse findings of the study. Seralini won a French lawsuit allowing him to express his concerns in public, and now Greenpeace has won a German court battle that makes public the data that is the source of his concerns.

Pusztai and Seralini spoke about the Mon 863 study at a June 22 press conference in Berlin organized by Greenpeace. Both scientists are uniquely qualified to evaluate the study. Seralini studies endocrine disruptors and the impact of pesticides on health. He was one of four experts appointed to respond to the WTO challenge filed by the US against the European Union’s policy on GM food and crops. He has read all of the industry’s GM-food submissions to Europe as well as all the commentaries on the submissions. Pusztai is the leading authority in his field of protein science (lectins) and had been commissioned by the UK government in the 1990s to develop the ideal testing protocol for all GM foods. Although his protocol was supposed to be adopted by the UK government and eventually in Europe, Pusztai’s controversial finding that GM potatoes damaged the health of rats ultimately stopped the work. Pusztai has also been commissioned to evaluate all published studies on GM foods, and has analyzed most of the confidential submissions made by industry.

Both scientists have expressed alarm about the unsupported arguments that Monsanto and some European regulators use to force product approvals. Now that the Mon 863 study is available, other scientists and the public can evaluate the industry’s defense, which Pusztai and Seralini say contradict well established scientific principles. Chief among their concerns are the ways Monsanto explains away statistically significant effects.

Faulty Comparisons Hide Problems

In animal feeding studies, researchers attempt to minimize differences between the test animals and the control groups, so that only the impact of the item being analyzed will stand out. In this study therefore, the test rats ate Mon 863 and the control group ate non-GM corn from the same parent line, i.e., corn whose genetics are the same except for the insertion of the genetic material and its impact. When comparing the results of these two appropriate groups, the health impacts were unambiguous and occurred at a rate that the scientific community accepts as not due to chance. But Monsanto and their supporters in the European Food Safety Authority (EFSA) appear to throw away the accepted methods of science that have been used for decades in order to rationalize the findings.

1. Researchers used six additional control groups, which were fed commercial corn varieties with entirely different genetics. While such comparisons are appropriate for commercial studies, it is entirely inappropriate for a safety assessment, according to Pusztai. Monsanto claimed that when the changes in the test rats were compared to this much larger, irrelevant control group, many changes were no longer significant.

2. In spite of the strained logic, many results were still statistically significant when compared to these six other controls and were reported as such by the laboratory that Monsanto used to conduct the study. Monsanto therefore ignored the study’s figures and claimed that since the changes in the rats were still within a wide range of reactions that are normal for the animals, they should be considered biologically irrelevant. Using this argument, for example, they declared that a 52% decrease in reticulocytes (immature blood cells) was "attributable to normal biological variability." According to Pusztai, an allowance of 5% variability is the norm in food experiments. Similarly, he says that the increase in blood sugar levels by 10% "cannot be written off as biologically insignificant, given the epidemic of diabetes."

To put Monsanto's claims into perspective, suppose that a large number of women who were fed a carefully controlled diet had a 25% increase in breast cancer compared to matched controls on another diet. Using Monsanto's logic, the findings can be dismissed because the increase was still within the normal variability of breast cancer for the whole population.

3. In spite of the statistical slight-of-hand, several results could still not be dismissed since they were well beyond the range Monsanto had defined as normal. So the company claimed that the potentially dangerous health effects were not considered significant because the reaction among the rats was not consistent between males and females. "This is really ridiculous," says Seralini, because everyone studying cancer and endocrinology, for example, knows that there are differences between genders.

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