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20.07.05, 20:07
GENETICALLY MODIFIED CORN STUDY REVEALS HEALTH DAMAGE & COVER-UP
By Jeffrey Smith
July 16, 2005
NewsWithViews.com
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.
4. When even the gender defense could not be applied to a particular finding,
Monsanto dismissed it since the reactions were not always dose specific.
Specifically, the results observed in rats fed a diet that was 11% Mon 863
were sometimes more pronounced than results found in rats fed a 33% diet.
Seralini notes that in endocrinology and toxicology research, differences are
not always proportional to effects noted. A small dose of a hormone, for
example, can cause a woman to ovulate, while a larger dose can make her
infertile.
5. When all other excuses failed, Monsanto claimed that with such a larg
