GMW: Spilling the Beans on lack of GM food testing

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GMW: Spilling the Beans on lack of GM food testing

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Spilling the Beans, November/December 2005

 

Genetically Modified Peas Caused Dangerous Immune Response in Mice

 

Other GM Foods are Not Tested for This and May Be Harmful

 

By Jeffrey M. Smith

 

SUMMARY

 

Genetically modified (GM) peas under development created immune

responses in mice, suggesting that they may also create serious allergic

reactions in people. The peas had been inserted with a gene from kidney

beans, which creates a protein that acts as a pesticide. When this

protein

is produced naturally in beans, it does not elicit a response from

mice. When produced in the GM peas, however, it did cause a reaction.

Using

sensitive testing methods, scientists discovered subtle differences

between the bean and the GM proteins - the added sugar chains were

slightly different. They speculate that this difference caused the immune

reactions. Based on the results of the study, the Australian developers

abandoned their 10-year, $2 million project.

 

This study reveals serious and potentially deadly flaws in the

regulations and assessments used to approve GM foods. GM crops on the

market,

like corn and soybeans, were never tested for immune responses using

animals and never subjected to a similar analysis of their proteins.

Thus,

the transgenic proteins in GM foods may have subtle undetected

differences that are causing health problems. It is sobering to note

that if

the GM peas were tested with only the methods used on soy and corn, it

likely would have been approved as well.

 

The approvals of genetically modified (GM) food are largely based on

four pillars. The first is the reliance on a long list of assumptions

about food safety. Unfortunately, these assumptions are principally based

on what was known about genetics 40 years ago, and many have been

overturned.

 

The second pillar is that safety research on GM foods is primarily

controlled by industry. Much of it is secret, and the few studies that

have

been made public are largely superficial—designed not to contradict the

assumptions.

 

The third pillar is an ineffective regulatory system, often hijacked by

people with close ties to industry. They accept unscientific

assumptions and poor research, and ignore adverse findings.

 

The fourth pillar is spin - merciless, relentless, in-your-face spin -

that magically flips facts to proclaim their opposite. Examples are

forthcoming.

 

On November 17, those pillars took a considerable beating. GM peas

under development were evaluated by tests normally applied to

medicine—not

to GM food.[1] The peas created a dangerous immune response in mice

which, if found in humans, might be life threatening. The 10-year pea

project, costing over $2 million dollars (US), was abandoned. If those

same

peas had been evaluated with tests used for other GM crops, however,

they could have sailed through the approval process anywhere in the

world.

 

The peas were developed by Australian scientists at the Commonwealth

Scientific and Industrial Research Organization (CSIRO) to assist the

country's $100 million pea harvest. They targeted the pea weevil, a pest

that takes a hefty bite—up to 30%—out of yields. But if weevil larvae

were to bite a GM pea plant, they would starve to death. That's because

the pea contains a protein called alpha-amylase inhibitor, an

anti-nutrient that interferes with the bugs' digestion. That protein

is produced

from a gene normally found in " common " (kidney) beans and when fully

cooked is safe for humans. Scientists spliced the gene into peas,

figuring it would be safe there as well.

 

Safety Assessment

 

Researchers checked the sequence of the kidney bean gene after it was

inserted into the pea's DNA. It hadn't changed during the insertion

process, but this is not always the case. Genes inserted into soybeans

and

corn, for example, were mutated, fragmented or truncated, and several

appeared to rearrange over time. Remarkably, safety assessments don't

always require that the transgene's sequence is determined. In the US,

for example, gene sequencing is not part of the approval process.

 

If a gene's sequence changes, it might create proteins with the wrong

amino acids. But analyzing the sequence of amino acids is also not

required. According to Bill Freese, a research analyst at Friends of the

Earth, " At present, the standard practice is to sequence just 5 to 25

amino acids, " even if the protein has more than 600 in total. They assume

that the rest are fine. Most of GM foods on the market have never had

their novel proteins sequenced. The GM peas, however, were checked. The

protein produced in the peas did have the same amino acid sequence as

the original in the beans.

 

Scientists at the John Curtin School of Medical Research inCanberra

tested the peas on mice, to see if they elicited an immune or allergic

response. Groups of mice were fed a commercial diet and also given GM

peas, non-GM peas or beans, twice a week for four weeks. After the

feeding

period, the mice were tested with a battery of immune response tests.

Reactions were elicited only in mice that were fed GM peas.

Specifically, injections of the GM protein into the footpad resulted

in significant

swelling; when introduced into the trachea, it caused mild lung damage

and tissue inflammation (similar to asthma in humans). Lymph nodes also

responded to the presence of GM protein. The researchers did not check

for allergies, per se, but used tests that they say are predictive of

allergenic sensitivity.

 

Simon Hogan, the lead researcher for the study, said, " The study is

fairly conclusive. " He added, " These types of assays are commonly used in

medical research. " They have not, however, been used in safety

assessments for GM foods on the market. Even though experts with the

Food and

Agriculture Organization and the World Health Organization (FAO-WHO)

recommend using animal studies to test for allergies, no government

actually requires it, and it is almost never done.

According to immunologist Ricki Helms, who has served on several expert

panels examining the potential allergenicity of GM foods, " Animal

models can contribute to the evaluation of allergenicity but cannot offer

absolute certainty. " This lack of certainty is a common justification by

industry scientists for why they don't use animal allergy studies as

part of their assessments. The two methods that they prefer, however,

also lack certainty.

 

In the first method, the transgenic proteins are put into test tubes

with digestive enzymes and acid to measure how quickly they are broken

down. This test is based on the fact that allergenic proteins often - but

not always - break down slowly in the stomach and intestines. The

problem is that test tube studies do not accurately predict what happens

inside humans. And even if they did, a protein that is broken down

quickly

may still cause allergies. Thus, potentially harmful allergenic

proteins can pass this test. In the other method, researchers search

databases

to see if the amino acid sequences of the transgenic protein are

similar to known allergens. This method also offers no guarantees -

not all

allergenic sequences have been identified and allergenic proteins can

certainly pass this test as well. In spite of the shortcomings of these

two methods, the FAO-WHO recommends them as part of the assessment and

offers specific criteria for each. Regulators can ignore those

recommendations. The GM soy, corn, and papaya on the market, for

example, fail

the FAO-WHO criteria. GM pea developer TJ Higgins told me that when his

peas were evaluated for protein stability and amino acid similarity,

they were " borderline. "

In addition to creating an immune response in mice, GM peas also

increased their immune system's sensitivity to other substances. For

example,

mice fed the non-GM peas showed no response to egg albumin. The GM-fed

mice did have an immune reaction to the albumin, as well as to three

other substances tested. The ability of one food to increase the

sensitivity to other foods is called an " adjuvant " response. It

suggests that

humans fed GM peas might develop allergic or immune responses to a wide

range of other foods. According to Judy Carman, an epidemiologist and

the director of The Institute of Health and Environmental Research in

Australia, " If a GM food was introduced onto supermarket shelves and

caused an immune reaction, it would be very difficult to find the

culprit,

particularly if it caused reactions to other, different foods, as this

GM pea was found to do. " As you probably guessed, adjuvant testing is

not part of any normal GM food approval process.

 

Independent researchers did test a GM product both for immune and

adjuvant responses using mice.[2] They tested one type of Bt-toxin

(Cry1Ac)

found in GM cotton, which is similar to Bt toxins produced in several

varieties of GM corn (Cry1Ab). Like the alpha-amylase inhibitor in peas,

Bt toxins kill pests. Not only did the Cry1Ac produce a significant

immune response, it elicited an adjuvant response as well. Another study

showed that Bt toxins in spray form caused antibody responses and

allergic symptoms in farm workers and others.[3] Taken together, these

studies overturned several safety assumptions. In spite of claims to the

contrary, Bt is not fully destroyed during digestion, it is bioactive in

mammals (including humans), and current safety assessments are

inadequate. By the time this research was done, Bt crops were already

planted on

millions of acres. Withdrawing them will apparently require more

evidence of human harm.

 

Another assumption used often by the biotech industry is that cooking

their GM crop will destroy its potential to create allergies. Cooking

can change the protein's structure, or " denature " it. Proponents have

claimed that when Bt is denatured, it is no longer effective as a

pesticide and will therefore no longer be allergenic. The GM peas were

boiled

for 20 minutes. After cooking, the alpha-amylase inhibitor was denatured

and was no longer effective in protecting against weevils. Industry

assumptions notwithstanding, the cooked pea protein still caused an

immune

response in mice.

 

Tracking Down the Cause

 

What was it about the transgenic protein in the GM peas that caused it

to affect the mice, when the " same " protein in its natural form in

kidney beans did not? This question intrigued Hogan and his team. He said

their " scientific, inquisitive nature " led them to look for subtle

differences in the protein structure. Although the amino acid

sequences of

the GM and non-GM proteins were identical, that doesn't tell the whole

story. Amino acids are the building blocks, and according to Carman, " If

you knock down a house and then study the pile of bricks, it won't

describe the house. Similarly, the amino acids don't reveal the

structure,

shape and unique characteristics of the protein. "

 

David Schubert of The Salk Institute for Biological Studies points out

that in higher organisms such as plants and animals, " each cell type

expresses a unique repertoire of enzymes capable of modifying protein

structure. " Depending on where they are, a protein may have added

molecular chains, " such as phosphate, sulfate, sugars, or lipids, " [4]

which

alter their function. In a 2002 article in Nature Biotechnology, Schubert

argues, " With our current state of knowledge, however, there is no way

of predicting either the modifications or their biological effects. " [5]

 

We can, however, detect such modifications. For instance, when sugar

chains are added to proteins, this process, known as glycosylation, can

influence allergic responses. Hogan's team used the sensitive MALDI-TOF

mass spectrometry technique, and confirmed that the GM and non-GM

proteins had slightly different glycosylation patterns. They believe that

these subtle differences may be the cause of the immune responses.

 

Here again is more bad news. The MALDI-TOF method is not required and

has rarely been used for the safety assessments of GM food already on

the market. According to Doug Gurian-Sherman, a senior scientist at the

Center for Food Safety and formerly at the US Environmental Protection

Agency, the differences in glycosylation between the GM pea protein and

the non-GM counterpart in kidney beans " would not be detected by the

tests that are currently required by US regulatory agencies. " If

companies do assess differences in protein, it is typically by " gel "

tests,

which won't reveal the subtle differences in glycosylation that may have

caused the immune response. In fact, TJ Higgins looked at gel tests in

the 1990s and did not see any difference between the GM and non-GM

proteins.

 

Approvals Rely on Dangerous Assumptions

 

Industry's assumption that proteins will act in a predictable manner in

a new organism has been pivotal and it certainly helped them get GM

foods approved. Take, for example, their acute toxicity tests where they

feed rodents just the isolated protein. They don't necessarily extract

the protein from the GM crop. Instead, they almost always produce the

protein using genetically engineered bacteria, since it is cheaper and

easier. They then test the animals' reactions to this surrogate protein,

assuming that if animals don't react to the bacterial form, then they -

and humans - won't react to the plant form.

 

These tests, therefore, avoid measuring the health impact of any

changes in the protein in the GM crops we actually consume. The pea study

revealed that significant, potentially deadly changes occurred when the

gene from kidney beans is inserted into peas - closely related species.

But the genes put into GM foods already on the market cross entire

kingdoms. Bacterial genes are spliced into GM soybeans, corn, cotton and

canola, and viral genes are inserted into papaya, zucchini and crook neck

squash. How these crops will alter bacterial proteins is anyone's guess

- unfortunately.

 

Glycosylation is related to another possible problem. Proteins are

sometimes folded in precise formations by specialized " chaperone " folders

inside the cell. If a novel protein appears in a species where it has

never before existed, the chaperone folders might not do their jobs

right. A mis-folded protein can be quite dangerous. In the case of the

peas,

the difference in glycosylation means that the protein is almost

certainly a different shape, but there may be other shape-related

issues that

contributed to the immune reaction in mice.

 

In addition to changes in the target protein, side-effects from the

gene insertion process can create toxins, allergens, or adjuvants.

Earlier

unpublished tests on the GM peas, for example, showed a doubling of

trypsin inhibitor, a known allergen, and a fourfold increase in an

anti-nutrient called a lectin. These or some other unknown change in

the peas'

composition might have played a part in increasing the immune

responsiveness of the mice. In short, we don't really know why

genetically

engineered peas are more dangerous. We do know that the body interprets

something in the pea as foreign, different, and offensive, and it reacts

accordingly. On the other hand, all GM foods, by definition, have

something foreign and different. It makes sense that the immune

systems in

humans or animals that have never eaten these novel substances before may

react to them.

 

A handful of studies that have looked for immune responses have found

them. In 1995, a Brazil nut gene inserted into soy DNA created an

allergic reaction in human blood, and the project was stopped.[6] In

1998, a

GM potato caused immune system damage in rats, among other problems.[7]

Studies implicating the Bt-toxin have already been cited above. On top

of those, a Bt potato caused abnormal and excessive cell growth in the

small intestine of mice.[8] A feeding study with Bt corn called MON 863

caused a significant increase in male rats of three types of blood

cells: basophils, lymphocytes (22%) and total white cell counts (20%).[9]

This strongly suggests that consuming GM corn caused changes in the

immune system. According to GM safety research expert Arpad Pusztai, " A

consistent feature of all the studies done, published or unpublished,

including MON 863, indicates major problems with changes in the immune

status of animals fed on various GM crops/foods, the latest example of

this

coming from the GM pea research in Australia. " [10]

 

We don't have the advantage of sophisticated human clinical trials, so

our evidence for immune reactions in humans is limited and preliminary.

For example,

 

Soy allergies jumped 50% in the UK just after GM soy was

introduced;[11]

 

An expert panel in the US determined that there was a moderate

likelihood that StarLink Bt corn contained a human allergen; [12]

 

Filipinos living next to Bt cornfields developed severe symptoms three

years in a row - only while the corn was pollinating; [13] and

 

A recent health report claims that Indian farm workers exposed to Bt

cotton developed moderate or severe allergic reactions. [14]

 

Certainly allergies and asthma are on the rise in many nations, but at

this point, we can only guess whether GM food plays a part. The pea

study provides a clue how it might be related.

 

Spin

 

No report on GM research is complete without the fourth pillar - spin.

How do you suppose the industry will respond to these pea findings that

expose an inept regulatory process that under normal test procedures

would almost certainly have allowed these peas onto the market? Consider

the response of GM pea developer TJ Higgins, " I think that this shows

that the regulatory system works. " [15]

 

But before we condemn Higgins as a spin master, we must consider that

he might have been the victim of spin himself. I have spoken with many

biotech scientists, people of high integrity and a strong belief in what

they are doing, who have absolutely no idea about the wretched state of

regulations or safety assessments. They focus on their own area of

expertise and have bought the industry spin about safety.

 

I called Higgins in Australia and quizzed him on the state of affairs

of regulations and assessments of other GM foods. He said, " I didn't

feel that we were breaking particularly new ground. . . . We were

following basically the recommendations for a proper risk assessment

and I feel

it is typical of the kinds of assessments that have been done for other

GM crops around the world. " Lead researcher Simon Hogan told me the

same thing. I pointed out to both scientists several unique features of

their study and challenged them to name a single GM food on the market

that has had the same level of tests. They couldn't come up with any, but

they were sure that these tests were done. They're in for a shock.

 

Years ago, a pro-GM scientist with high integrity also had confidence

in GM regulators and industry scientists. Higgins had asked him to

coauthor a rat feeding study with his GM peas, because the scientist

was the

world's most qualified person to do the work. This scientist was also

awarded a UK government research grant to create a rigorous safety

assessment protocol, which was to be required in the UK and eventually

the

EU. One day, he was asked to review several confidential industry

studies that were used to get GM foods approved. He told me that reading

those studies was perhaps the greatest shock of his life. The studies

were

so superficial, so poorly done, he realized that industry was doing as

little as possible to get their foods on the market as quickly as

possible. They were not doing safety studies. A few weeks later, this

scientist confirmed that a GM potato he was working on caused

considerable

damage in rats, including damage to their immune systems. Unlike Higgins,

this man knew full well that his dangerous potatoes could have sailed

through industry " safety " studies and onto plates around the world. He

went public with his concerns.

 

The scientist's name is Arpad Pusztai, and he paid dearly for his

integrity. At the hands of a pro-GM government and industry-backed

scientists, he was fired, silenced with threats of a lawsuit and

mercilessly

attacked. It was biotech spin at its " finest. "

 

Pusztai has since published his potato research and is now considered a

top expert in GM safety testing. He just published a review of all the

peer-reviewed assessments and has studied nearly every industry

submission. He assured me that the GM pea immune study does, in fact,

break

new ground. Likewise, Professor G.E. Seralini, who has officially

reviewed all of the submissions to Europe as well as all the

commentaries on

the submissions, wrote me: " To my knowledge, no GM plant on the market

has undergone such detailed experiments to assess allergenicity. " Doug

Gurian-Sherman and Bill Freese, who are experts on submissions to US

authorities, also acknowledge that industry immune studies are

considerably weaker than the pea study. And Judy Carman, who has

studied the GM

applications to Australia and New Zealand, concurs. In fact, Marc

Rothenberg, who is a co-author of the pea study and was also on the

expert

panel that analyzed the allergenicity of StarLink corn, said of the pea

research, " It was very unique. It was much more extensive and rigorous

than what was previously done. "

 

It appears that the director of the pea assessment (Higgins) and the

lead researcher in the study (Hogan) were uninformed about the state of

affairs in GM crop assessments. They appeared to be unaware that their

study was actually a breakthrough. If Higgins had known that his peas

would likely have been approved if they were tested only with the less

expensive, less rigorous research typically used for GM crops, he might

not be so quick to defend GM regulations worldwide.

 

I sent Higgins a peer-reviewed paper called " Safety Testing and

Regulation of Genetically Engineered Foods. " [16] It not only shreds the

assessment process in the US, it also presents a case study of how one GM

corn variety gained approval based on wrong assumptions, poor research,

ineffective regulations and spin - the four pillars. I wrote Higgins, " I

am confident that after reading this article, you will agree with the

authors that the tests used for approving this Bt corn, as well as other

varieties, were not sufficient to protect the public. " I asked that he

then make corrective statements about GM regulations. More importantly,

Higgins is The Deputy Chief of CSIRO Plant Industry. If he acknowledges

that even one GM crop has not been thoroughly tested, I asked him to

propose that his organization immediately conduct rigorous safety

assessments on that crop to protect the health of consumers. I

understand that

CSIRO has business relationships with Bayer Crop Science and Monsanto.

The close ties between research organizations and the biotech industry

has, in many instances, stifled criticism of GM crops and even stopped

important research from being conducted. I am hopeful that Higgins, who

pioneered new safety assessments on GM food crops and canceled his own

10 year pea project based on the findings, will direct his institution

to similarly break new ground. I will be sure to report his response in

future columns.

 

In the meantime, my Institute for Responsible Technology is passing the

hat to collect money to fund independent research on the GM foods

already on the market. We are not willing to wait.

 

Jeffrey M. Smith is the author of Seeds of Deception, and is working

with a team of international scientists to compile all known risks of GM

foods.

 

The letter to TJ Higgins can be found by clicking here.

http://www.seedsofdeception.com/utility/showArticle?objectID=305

 

Spilling the Beans is a monthly column available at

www.responsibletechnology.org. Publishers and webmasters may offer

this article or monthly

series to your readers at no charge, by emailing

column. Individuals may read the column each

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www.responsibletechnology.org.

 

REFERENCES:

[1] V. E. Prescott, et al, Transgenic Expression of Bean r-Amylase

Inhibitor in Peas Results in Altered Structure and Immunogenicity, J.

Agric. Food Chem. 2005, 53

[2] Cry1Ac protoxin is a systemic and mucosal adjuvant (Vazquez-Padron

et al, 2000b)

[3]Bernstein, et al., (1999). Immune responses in farm workers after

exposure to Bacillus thuringiensis pesticides. Environmental Health

Perspectives 107(7), 575-582

[4] David Schubert, " A different perspective on GM food, " Nature

Biotechnology vol. 20, 2002, p. 969

[5]David Schubert, " A different perspective on GM food, " Nature

Biotechnology vol. 20, 2002, p. 969

[6] J Ordlee, et al, " Identification of a Brazil-Nut Allergen in

Transgenic Soybeans, " The New Englandd Journal of Medicine, March 14, 1996

[7] Pusztai, A. et al. (2003) Genetically Modified Foods: Potential

Human Health Effects. In: Food Safety: Contaminants and Toxins (ed. JPF

D'Mello) pp.347-372. CAB International, Wallingford Oxon, UK, also

additional communication with Arpad Pusztai

[8]Nagui H. Fares, Adel K. El-Sayed, Fine Structural Changes in the

Ileum of Mice Fed on -Endotoxin- Treated Potatoes and Transgenic

Potatoes,

Natural Toxins Volume 6, Issue 6, 1998. Pages: 219-233 Published

Online: 29 Jun 1999

[9]

http://www.monsanto.com/monsanto/content/sci_tech/prod_safety/fullratstudy.pdf

[10] October 24, 2005 correspondence between Arpad Pusztai and Brian

John

[11]Mark Townsend, " Why soya is a hidden destroyer, " Daily Express,

March 12, 1999

[12] SAP Report No. 2000-06, December 1, 2000, FIFRA Scientific

Advisory Panel Meeting, November 28, 2000, Assessment of Scientific

Information Concerning StarLink™ Corn

[13]Jeffrey M. Smith,Bt-maize (corn) during pollination, may trigger

disease in people living near the cornfield, Press Release February

2004,http://www.seedsofdeception.com/Media-maizepollen.php and Allen V.

Estabillo, Farmer's group urges ban on planting Bt corn; says it could be

cause of illnesses, Mindanews / 19 October 2004,

http://www.seedsofdeception.com/Media-update-Philippines-BT-corn.php

[14] Bt cotton causing allergic reaction in MP; cattle dead, Bhopal,

Nov 23 2005

http://news.webindia123.com/news/showdetails.asp?id=170692 & cat=Health

[15] GM crop failure shows rules force: CSIRO November 19, 2005,

http://www.theage.com.au/news/National/GM-crop-failure-shows-rules-force-CSIRO/2\

005/11/19/1132017013629.html

[16] William Freese and David Schubert, Safety Testing and Regulation

of Genetically Engineered Foods, Biotechnology and Genetic Engineering

Reviews – Vol. 21, November 2004,

http://www.foe.org/camps/comm/safefood/gefood/testingregbackgrounder.pdf

 

 

© Copyright 2005 by Jeffrey M. Smith. Permission is granted to

reproduce this in whole or in part.

 

 

 

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