GM Corn Study Reveals Health Damage & Cover-Up

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GENETICALLY MODIFIED CORN STUDY REVEALS HEALTH DAMAGE & COVER-UP

 

http://www.newswithviews.com/Smith/jeffrey7.htm

 

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

large study, one would expect lots of results to fall in the

statistically significant category purely by chance. Thus, no

follow-up is required.

 

Seralini says, " It is dishonest not to do the tests again if you have

statistical significance. " Pusztai similarly asks, " What is the point

of doing a study if you dismiss the results you find? " He insists that

you design a study specifically so that statistical significance

indicates biological significance.

 

In spite of the fact that Monsanto's explanations were at odds with

time-honored principles of science, the European Food Standards Agency

(EFSA) recommended that Mon 863 be approved. In fact, the agency's

justification mimics that of Monsanto, point for point. In spite of

EFSA's recommendation to approve Mon 863, the majority of the

countries in the EU Council of Ministers voted not to approve the corn

on July 24, 2005. But EU law requires a " qualified majority " on such a

vote, and so the pro-GM European Commission is now authorized to make

the decision and is expected to approve Mon 863 within a few months.

 

Mon 863 will not be the first approved GM food in Europe to have shown

significant health effects in rats. According to Seralini, an oilseed

rape (GT 73), Roundup Ready corn (NK 603), and two Bt corn varieties

(Bt11 and Mon 810) all showed statistically significant problems that

regulators did not pursue with follow-up research. Seralini said that

the effects of the GM crops were similar to that of pesticides. Some

included inflammation disorders and problems in the livers and

kidneys, the two major organs involved with detoxification. Seralini

is part of a research group raising money to do independent research

on a GM variety he says showed more than 50 significant rat anomalies.

 

GM Food is Prone to Unpredicted Effects

 

How can a GM crop create so many significant unpredicted side effects?

There are several ways. The process of gene insertion, for example,

typically results in hundreds or thousands of mutations throughout the

genome. Insertion also changes the amount of protein that natural

genes produce (5% of the genes in one study) and can destroy natural

genes altogether. The protein created by the inserted gene may also

create allergies or toxins. Several studies indicate, for example,

that the Bt pesticide may cause allergic or immune system effects.

Furthermore, according to Monsanto's submission on Mon 863 to

Australia and New Zealand, some of the foreign genetic material that

was added into the corn was mutated during the insertion process. This

means that the composition of the Bt protein that the corn creates is

actually different than the one scientists intended.

 

With so many ways to create side effects, many scientists and consumer

groups are demanding extensive evaluations and insist that a simple

90-day rat experiment is not competent to protect the public. In the

EU, pesticide approvals require research on three types of mammals,

with feeding studies ranging from 90 days to two years. Seralini

points out that Bt crops create new pesticides. Mon 863, for example,

is unique; it differs from the natural version of Bt pesticide in

seven ways and should, according to Seralini, require at least the

same level of evaluation as chemical pesticides. The same holds true

for herbicide tolerant crops, which are engineered to survive large

applications of weed killers such as Monsanto's Roundup. Seralini

points out that these GM plants have far more herbicide residues in

the edible portions and extensive toxicity tests must be performed.

But the biotech industry claims that they could not afford to

introduce GM crops if they had to pay for the tests normally required

for pesticides in Europe. For GM crop approvals in the US, they spend

even less. US authorities require only 30-day studies for the Bt

plants and no safety tests whatsoever are required for herbicide

tolerant varieties.

 

Flaws in the Mon 863 Study Should Have Caused It to be Rejected

 

According to Pusztai, the quality of Monsanto's study was well below

that normally required for a peer reviewed publication. He says, " It

is odd, therefore, that it remains the central document considered by

government regulatory authorities upon which to make a decision to

protect the health of European citizens. "

 

Several features of the study appear to have been rigged to avoid

finding problems. Nutritional studies, for example, typically use

young, fast-growing animals, which are sensitive to toxic and

nutritional effects. By using a mix of young and old animals,

Monsanto's research design may have hidden serious problems.

Similarly, they used rats with a huge range of starting weights.

According to Pusztai, the starting weights in a rat feeding study

should not vary more than 2% from the average. By contrast, the male

starting weights in Monsanto's study ranged from 198.4 to 259.8 grams

(or 143 to 186 grams according to the conflicting data in the study's

appendix). In either case, says Pusztai, the wide range " can make it

impossible to find significant differences in animal weights at the

end of the experiment. "

 

Monsanto tested the effects of two diets: in one Mon 863 constituted

33% of the rats' diet, and in the other, it was 11%. Even in the 33%

group, GM corn protein comprised only about 15% of the rats' total

protein. According to Pusztai, researchers should have started with

the maximum amount of corn possible (while maintaining a balanced

diet), and then used lower concentrations to evaluate any dose effect.

(Since rats are stand-ins for humans, it is interesting to note that

African aid recipients typically rely on corn for 90% of their total

caloric intake.) Researchers also supplemented the corn with a

commercial animal feed. Although its composition wasn't reported, it

may have contained GM soy, which could have skewed the results.

 

The study relied on analytical methods that are half a century old and

ignored powerful new methods, such as profiling techniques, DNA chips,

proteomics, and others. They relied on just two observation times

(week 5 and week 14), which will not give data about the intervening

periods. And the short 90-day time period will miss chronic and

reproductive problems, as well as problems in the next generation.

 

The analysis of the findings was obscured by using six irrelevant

control groups fed commercial diets, as well as data from historical

databases. Such comparisons are totally unacceptable in the field of

nutrition. According to Pusztai, " The study should have included a

control group fed the non-GM parent line, spiked with the Bt obtained

from the Mon 863. If rats reacted badly to this diet, it would show

that the genetic engineering process and its unpredicted side effects,

and not the Bt toxin, were responsible. Pusztai says, " A second

parental line spiked with a known toxin would also be useful as a

positive control, " to make sure the measurements are sensitive enough

to detect the expected impact of the toxin. Without this, it is

difficult to know if the methods were working properly.

 

Monsanto also defended changes in kidney weights by comparing the

values with a separate study, which used different corn genetics and a

different lab. According to Pusztai, this absurd inter-experimental

comparison is never done and should be disregarded.

 

Some of the reported weight measurements were also bizarre, suggesting

possible problems with animal management or faulty data. One rat

dropped 53 grams in one week and gained 102 grams in the next. Some

that were heaviest at the beginning of the experiment were the

lightest at the end. And the rats hardly grew at all during the last

four weeks.

 

Overall, the research paper was confusing, conflicting, and poorly

reported. It failed to disclose, for example, the nutritional

composition of the feed - backed up by chemical analysis - and the

methods used to measure changes in the animals. Since these most basic

requirements for a nutritional study were not provided, the research

cannot be repeated and the results remain suspect.

 

Referring to the study as a whole, Pusztai says, " Nutritional

scientists and leading journals would not accept these blatant

inadequacies and misinterpretations. "

 

The Politics of Science Fails to Protect the Public

 

When Seralini wanted to voice his concerns about the industry's safety

studies, he was told by French authorities that he was legally bound

to keep even his opinions confidential. A lawsuit eventually granted

him the right to speak, but until June 20, 2005, biotech companies

were able to keep their feeding studies hidden by claiming that they

contained confidential business information. Seralini says that " No

one can understand, even among EU regulators, why the composition of

the blood of rats that have eaten the GM is secret. " The precedent

established by the German court may open the door for more biotech

studies to be made public. Without disclosure, says Seralini, just a

few toxicologists can make the decision without public evaluation. And

too often, the decision-making body is heavily influenced by the

applying company.

 

In his French Commission for Biomolecular Genetics (CBG), for example,

the government nominates three candidates for the position of the very

important " external referee. " That referee studies the application and

presents the relevant facts to the 18-member committee. For about ten

years, the applicant companies such as Monsanto were able to choose

which candidate of the three was to be the referee overseeing their

products' approval process. Seralini says, " I had a big fight with the

commission " over the conflict of interest. As a result, the government

changed the rules, and for the Mon 863 application they allowed the

president of the commission the right to choose the referee. The

president, however, is a geneticist who works very closely with

industry. He appointed the same person that the biotech industry had

chosen in the past.

 

After the CBG failed to approve Monsanto's corn in 2003, the president

asked for an outside scientist to re-evaluate just one of the

significant differences - kidney weight. According to Seralini, the

consultant ignored the blood and liver disorders entirely. And no

additional research was actually conducted; the consultant simply

re-examined the same data and declared the results insignificant. The

commission scheduled another vote, but failed to achieve a quorum. The

president ruled that a quorum would not be needed in the next meeting,

and only five members showed up. The president cast the deciding vote

that approved Mon 863, 3 votes to 2. The other votes in favor came

from the commission's vice-president, who works at an organization

that conducts agricultural research, and a scientist. According to

Seralini, the scientist is a toxicologist who, oddly enough, is

" always against long animal toxicity tests. " In fact, he had been part

of the French committee that approved Novartis (now Syngenta) E 176

corn after it had been tested for only two weeks with three cows.

Actually, there were four cows at the start of the study, but one died

and was removed.

 

The toxicologist is also on the European Food Standards Agency that

endorsed Mon 863. EFSA has come under attack for including primarily

pro-GM scientists. According to a November 2004 report by Friends of

the Earth, " One member has direct financial links with the biotech

industry and others have indirect links. . . . Two members have even

appeared in promotional videos produced by the biotech industry. " And

several members, including the chairman, have been part of an

EU-funded project with the stated goal to " facilitate market

introduction of GMO's in Europe. "

 

US Pushes its Agenda, and its Pests, on Europe

 

The United States government's support for biotech is no secret. In

fact, it is the official policy in several US agencies to promote the

industry, and some of them have attempted to push acceptance of GM

crops in Europe. In the case of Mon 863, it seems that the corn is

designed to solve a European problem that the US introduced. The corn

is engineered with a pesticide to attack insects such as Diabrotica.

According to Seralini, " Diabrotica is from a very dangerous family of

insects for a wide range of crops and was absent from the European

countries until the late 1990s, forbidden even in laboratories because

it is very difficult to eliminate it with known chemical

insecticides. " He says it appears to have entered Europe from the US

in large numbers during the Balkan war. Specifically, it was

widespread around US military airports, whose planes were likely to

have carried the pest. It has since spread primarily in Italy, France,

and Germany.

 

According to Seralini, " Monsanto seems to have anticipated this

problem. " Before any infestation had been discovered, they were

already field testing their corn in France in the late 1990s. Since it

takes about five years of local field trials for a GM variety to be

accepted in an EU nation, such early testing was necessary.

 

In addition to the crop pests, Europe may have also imported the US

tradition of approving GM products based on faulty studies. Documents

stolen from the US FDA reveal that when Monsanto's researchers

intended to illustrate that their GM bovine growth hormone did not

interfere with cows'; fertility, they allegedly added cows to the

study that were pregnant prior to injection. An FDA whistle-blower

also charged that sick cows were removed from industry studies

altogether (see Seeds of Deception, chapter 3).

 

Critics demand that regulators use independent studies, not industry

studies, to prevent manipulation of data. But there are only a few

independently funded researchers. Biology professor Bela Darvas of

Hungary's Debrecen University is one of them. After discovering that

one of Monsanto's Bt corn varieties, Mon 810, is lethal to two

Hungarian protected species and one insect classified as a rare, he

ran into an unexpected obstacle. Now Monsanto refuses to give him any

more Mon 810 corn to use in his tests. They also refused his request

for Mon 863.

 

Perhaps with the court's release of Monsanto's rat study, the public

will demand a more thorough investigation into GM foods and a change

in the review and approval process. Until then, Europeans are

relatively safe from the unintended effects, since most manufacturers

refuse to use even approved GM ingredients there (with the exception

of animal feed). Meanwhile, consumers in the US will unwittingly serve

as the guinea pigs.

 

Additional Information

 

1, Dr. Arpad Pusztai's review comments commissioned by the German

authorities on both the full 90-day study and a Monsanto summary.

2, For Dr. Pusztai's review, in easy-to-read table form, of some of

the significant differences found in the rat-feeding study,

3, For Dr. Pusztai's list of reasons why the Mon 863 study should have

been rejected,

4, See detailed information on the study provided by Professor

Seralini to the Greenpeace press conference at: Click Here.

5, For the full 1139 page study, go to:

6, For Monsanto's 11 page summary of safety information, go to: click

here.

7, For the Friends of the Earth report on conflicts of interest in the

European Food Standards Agency, go to:

 

© 2005 Jeffrey M. Smith-

 

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Jeffrey M. Smith has been involved with genetically modified (GM)

foods for nearly a decade. He worked for non-profit and political

groups on the issue and in 1998, ran for U.S. Congress to raise public

awareness of the health and environmental impacts. To protect

children-who are most at risk from the potential health effects of GM

foods-Smith proposed legislation to remove the foods from school

meals. He also proposed legislation to help protect farmers from

cross-pollination by GM crops. Later, he was vice president of

marketing for a GMO detection laboratory.

 

Smith has lectured widely, spoken at conferences, and has been quoted

in articles around the world. Prior to working in this field, he was a

writer, educator, and public speaker for non-profit groups, advancing

the causes of health, environment, and personal development. This book

Seeds of Deception, researched and written after he left the industry,

combines Smith's passion for these causes with his extensive knowledge

of the risks and cover-ups behind genetically modified foods.

 

Smith is the founding director of the Institute for Responsible

Technology, a member of the Sierra Club Genetic Engineering Committee,

and a member of the advisory board of the Campaign to Label

Genetically Engineered Foods. He has a master's degree in business

administration and lives with his wife in Iowa, surrounded by

genetically modified corn and soybeans.

 

Website: www.seedsofdeception.com

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