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Monsanto's Secret Study Shows Health Hazards of New GE Corn

From: <gaia@gaianety.org June 23, 2005

Dear Friends and Colleagues,

A Monsanto study on a new type of GM Bt maize shows significant harm caused to rats fed on the variety, called MON 863. The study shows kidney abnormalities and unusually high levels of white blood cells. It raises serious concerns about the impacts of GM foods on human health.

Of course, in spite of the irregularities in the health of the rats fed the GM maize, the Monsanto report concluded that these were irrelevant, and should not be attributed to the GM maize itself, even though the rats fed non-GM exhibited no such problems.

Monsanto had tried to suppress their own study, although they had been obliged to hand it in to European regulatory bodies while they consider approval of the maize in Europe (to be decided by vote on this Friday the 24th June). Monsanto had claimed that their study could not be made public as it was ³confidential business information².

The German government, alongside Greenpeace, contested Monsanto¹s claim. On Monday the 20th, a German court overruled Monsanto¹s appeal, and the data was finally made available to the public.

Two scientists, Dr Arpad Pusztai and Prof Eric-Gilles Seralini, who had reviewed the study for the German and French governments, but who had been forbidden from speaking out about it, were finally able to break their silence and reveal their concerns about the safety of MON 863.

Not only were the effects on the rats cause for concern, but according to the scientists, the design of the experiment was poor, and Monsanto¹s own conclusions laughable. They were clear that Friday¹s EU Environment Council vote should not give approval to MON 863 while there are serious doubts about the safety of the food.

MON 863 also contains a gene for antibiotic resistance, which under EU law should be avoided.

The study seems to back a study carried out by Dr Pusztai 6 years ago, on the effects of GM potatoes on rats. Dr Pusztai, one of the world¹s leading toxicologists, had found serious impacts on the health of the rats. But his conclusions were inconvenient to the biotech-funded scientific establishment and the biotech-enthusiast British government. He was widely criticized, accused of using flawed methodology, and fired from his job. But nobody was interested in repeating the experiment to see if it held true or not.

This new report, from Monsanto¹s own laboratory, goes a long way to show that concerns about the health impacts of GM crops should not be ignored. Best wishes, Teresa

*******************************************
1. GM Maize Has Risks and Side Effects
Press Release from Greenpeace. Date: 22 June 2005
2. Monsanto Ordered to Make Secret Study public
Article from Greenpeace. Date: 20 June 2005 http://eu.greenpeace.org/issues/news.html#050620=5Fa
3. Monsanto's GM Corn: Unfit for Rats, Unfit for Humans
Background information on MON863 from Greenpeace. Date: June 2005
4. Revealed: Health Fears Over Secret Study into GM Food
Article from the Independent. Date: 22 May, 2005 http://news.independent.co.uk/world/science_technology/story.jsp? <http://news.independent.co.uk/world/science_technology/story.jsp? story=640430
5. When Fed to Rats it Affected their Kidneys and Blood Counts. So What
Might it do to Humans? We Think You Should be Told
Article from the Independent. Date: 22 May 2005
Geoffrey Lean
http://news.independent.co.uk/world/science_technology/story.jsp?
<http://news.independent.co.uk/world/science_technology/story.jsp?
story=640402
6. Why the Mon 863 Study Should Have Been Rejected
Material provided by Professor Arpad Pusztai for Greenpeace press
conference. Date: 22 of June
****************************************

1. GM Maize Has Risks and Side Effects

Press Release from Greenpeace. Date: 22 June 2005

Greenpeace publishes company documents on rat-feeding trials BERLIN Greenpeace is today publishing confidential Monsanto corporation documents on feeding trials conducted on rats using genetically manipulated (GM) maize. The animals displayed negative health effects after being fed Monsanto's Mon863 GM maize, which produces an insecticidal toxin.

The higher administrative court in Münster released the documents on Monday after Greenpeace had successfully pressed to inspect them in accordance with the EU law on environmental information. The judgement sets a precedent for cases in which companies keep their documents on GM-plant risk assessment secret. The EU environment council in Luxembourg will decide whether to authorise imports of this maize on Friday. Greenpeace and scientists are together calling for an import ban on Mon863; the German government should vote against it being authorised.

"The GM maize should not be allowed to be licensed as food or feedstuff in EU countries," said Professor Gilles-Eric Seralini of the French state Commission du Genie Biomoleculaire (CGB), which is responsible for risk assessments of GM plants.

"If a trial produces such striking results, it must at all events be repeated."

The release of the documents means that scientists like Professor Seralini are no longer bound to maintain confidentiality. "The safety standards in EU authorisation procedures for genetically manipulated plants are in general inadequate," said Professor Seralini, speaking at a Greenpeace press conference in Berlin.

Professor Arpad Pusztai, who had already made a risk assessment of Mon863 for the German government, also warns against allowing the maize to be
licensed. "It cannot be presumed that the damage to the rats' inner organs and the animals' blood picture are based on chance. The documents also show that the set-up for the experiments was inadequate and evaluation of the data incorrect. Further investigations are absolutely necessary."

Mon863 produces a so-called Bt-toxin, to protect it against the corn rootworm. This toxin is not identical to the substance contained in GM plants already licensed in Europe and which makes them resistant to the corn borer. Mon863 furthermore contains a controversial gene conferring resistance to antiobiotics, which according to EU release Directive 2001/18/EC should be avoided. It cannot be ruled out that the gene sequence will transfer to disease-causing agents and thus encourage the creation of new resistant pest organism.

The ministers will also vote in Luxembourg on existing national bans on the importing and cultivation of GM plants. Five EU countries including Germany are appealing to a national protection clause in the EU law. The Commission has called on countries to lift the bans. To date only the UK and the Netherlands are supporting the EU Commission.

"Few countries want to have their rights curtailed," says Greenpeace's Christoph Then. "Lifting national restrictions must be rejected just as the authorisation of Mon863 GM maize must be. The EU must prove that it believes in the importance of protecting consumers and the environment."

NOTES TO EDITOR

Please direct your enquiries to Christoph Then, mobile phone no. +49 (0)171-878-0832, or Simone Miller, press officer, tel. + 49 (0)171 870 6647. You can obtain a paper with background information by calling +49 (0)40-30618 386. Greenpeace is on the internet in Germany at www.greenpeace.de <http://www.greenpeace.de/ and internationally at www.greenpeace.org <http://www.greenpeace.org/

************************************

2. Monsanto Ordered to Make Secret Study Public

Article from Greenpeace. Date: 20 June 2005 http://eu.greenpeace.org/issues/news.html#050620=5Fa <http://eu.greenpeace.org/issues/news.html#050620=5Fa

Brussels, 20 June 2005 A German law court (1) today ordered biotechnology firm Monsanto to disclose a suppressed report on rat feeding trials related to the company's genetically modified maize MON863. The decision follows a campaign by Greenpeace to gain access to the document under EU
law. EU environment ministers will vote on the maize's import authorisation this Friday, 24 June.

"This ruling is a victory for transparency over company secrecy regarding the impacts of genetically modified organisms. EU member states should not be pushed into approving this maize before independent scientists have had a chance to examine the findings," said Eric Gall, Greenpeace European Unit GMO policy adviser.

Monsanto has consistently tried to prevent the publication of the 1,000- page document, after concerns were raised regarding the health impact on rats of MON863.

The German state endorsed Greenpeace requests to access the document under EU law, but Monsanto introduced a case against Germany to prevent the disclosure. Today's decision overrules the company's appeal against the decision in this case, originally delivered on 10 June 2005.

Two renowned toxicology experts - Gilles-Eric Seralini and Arpad Pusztai
- will present their analysis of the study at a Greenpeace press conference in Berlin on Wednesday.

On Friday, environment Ministers will vote not only on MON863 but also on so-called national bans imposed by five member states against the use and cultivation of GMOs.

Contact:
Eric Gall, Greenpeace European Unit GMO policy adviser, tel +32 (0)496 161 582 Christoph Then, Greenpeace International GMO campaigner (in Germany), tel +49 171 878 0832 Katharine Mill, Greenpeace European Unit media officer, tel +32 (0)496 156 229 Notes:
1. Oberverwaltungsgericht M=FCnster

--
Katharine Mill, media officer Greenpeace European Unit tel +32 2 274 1903/+32 496 156229 Katharine.Mill@diala.gl3 <mailto:Katharine.Mill@diala.gl3 http://eu.greenpeace.org <http://eu.greenpeace.org/

*******************************************

3. Monsanto's GM Corn: Unfit for Rats, Unfit for Humans

Background information on MON863 from Greenpeace. Date: June 2005

MON863 is a genetically modified corn which expresses a Bt-toxin (Cry3Bb1). This toxin, which stems from a micro-organism (Bacillus thuringiensis), is meant to protect the maize against a pest called corn rootworm. This GM maize is different from those Bt-plants (Mon 810, Bt11, Bt 176) already placed on the market, as they produce another toxin (Cry1Ab), which is toxic to the European corn borer. Further, the GM maize contains an antibiotic resistance marker gene, which should be not used according to recent EU law. On 23 April 2004 the French newspaper Le Monde revealed that the French expert body in charge of GMO evaluation (CGB, Commission du Genie Biomoleculaire) had expressed doubts about the safety of GM maize Mon 863.

By filing application for market authorisation under EU law, Monsanto had delivered the results of a rat feeding study to EU government authorities. These results show that significant variations were found between the rats fed with conventional maize and those fed with GM maize Mon863, such as an increased number of white blood cells in the males, reduced immature red blood cells in females, a significant increase in blood sugar in the females or a higher frequency of physical irregularities in the kidneys of the males, such as reduced weight and inflammation.

Victory for transparency a precedent When it filed the application to market MON863, Monsanto requested that crucial documents concerning the risk assessment, like the results of rat feeding trials, should be classified as confidential. But according to European law the public has a right to have full access to information concerning the risk assessment of GMOs. Article 25 of Directive 2001/18/EC states that : "2. The notifier may indicate the information in the notification submitted under this Directive, the disclosure of which might harm his competitive position and which should therefore be treated as confidential. Verifiable justification must be given in such cases.

3. The competent authority shall, after consultation with the notifier, decide which information will be kept confidential and shall inform the notifier of its decisions."

Article 25 (4) also indicates that "in no case" should the information related to "environmental risk assessment" be kept confidential.

Article 2 (8) of Directive 2001/18 defines "environmental risk assessment" as "the evaluation of risks to human health and the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of GMOs may pose and carried out in accordance with Annex II."

In Annex II of Directive 2001/18 the general principles declare that the risk assessment should : "be carried out in a scientifically sound and transparent manner based on available scientific and technical data".

It took more than a year for Greenpeace to see the interests of society finally prevail over Monsanto's economic interests and its policy of opacity and secrecy.

· On 5 May 2004, Greenpeace wrote to the German agriculture ministry, which was in charge of the initial risk assessment report, to request access to the full documents concerning Mon 863.

· On 4 August 2004, the German agriculture ministry replied that the applicant, Monsanto, had refused to agree to publish the initial rat study MSL-18175, which had been classified as "confidential business information". · On 21 March 2005, the Gerrman authority decided to give access to the full document, because Monsanto could not show that its request for confidentiality was backed by EU or national law.

· On 27 April 2005, Monsanto filed an appeal against the decision of German government and, in addition, took out an injunction to stop the authorities publishing the data.

· On 9 June 2005, the German court decided to reject Monsanto's request; the data could not be seen as confidential, the right of society to transparency had to be given more weight than Monsanto's economic interests. The company appealed the decision.

· On 20 June, the court rejected the appeal, and ruled that the documents be made public.

Serious safety concerns Greenpeace's ongoing examination of the material provided by Monsanto gives rise to serious concerns.

Monsanto's results reveal many irregularities in the study and five significant differences between the rats fed with the GMO maize and the control groups, which were fed conventional maize.

These include statistically significant differences in white blood cells. These cells are an indicator of abnormal situations in the body such as infections and inflammations. Furthermore, there are differences in the organ weight of the kidneys and some abnormal changes in the structure of the kidneys.

Monsanto tries to negate these findings by use of "reference" and "historical" control data collected from other experiments where rats were fed non-GM maize. Such inclusion of "historical" or "reference" data is hardly valid from a scientific point of view. It is the direct comparison between two or more groups during a certain experiment that is the critical and valid comparison in normal scientific practices. As soon as statistically significant differences appear, one should immediately check for further evidence, run further experiments to try to find out where those differences come from. This is particularly important as this feeding trial was only conducted over 90 days. The high number of statistically significant differences therefore raises severe doubts regarding the food and feed safety of this GMO maize.

Since the study indicates that this GM maize has the potential to negatively affect the health of rats, there are grounds for concern that it could also interfere with the metabolism of humans and other animals. This is a valid reason for rejecting the request for market permission.

Furthermore, the experiment was not well designed. Important data and parameters are missing. And, as it took only 90 days, it remains impossible to draw any conclusions regarding the effects of long-term ingestion of the maize.

Greenpeace's position has been confirmed by two new scientific opinions by renowned experts in the field, presented in Berlin on 22 June 2005:

Professor Gilles-Eric Seralini, a member of two GMO evaluation committees within the French ministry of agriculture and ministry of ecology, and Professor Arpad Pusztai, who was invited some months ago by the German government to give an opinion on this GM maize. Both support Greenpeace's position that this maize should not receive market authorisation, given the data known so far.

Conclusion

The high number of statistically significant differences between rats fed MON863 and the control groups in this short feeding trial give sufficient cause for concern to justify rejecting MON863 outright.

******************************************

4. Revealed: Health Fears Over Secret Study into GM Food

Article from the Independent. Date: 22 May, 2005 http://news.independent.co.uk/world/science_technology/story.jsp? <http://news.independent.co.uk/world/science_technology/story.jsp? story=640430

Rats fed GM corn due for sale in Britain developed abnormalities in blood and kidneys Rats fed on a diet rich in genetically modified corn developed abnormalities to internal organs and changes to their blood, raising fears that human health could be affected by eating GM food.

The Independent on Sunday can today reveal details of secret research carried out by Monsanto, the GM food giant, which shows that rats fed the modified corn had smaller kidneys and variations in the composition of their blood.

According to the confidential 1,139-page report, these health problems were absent from another batch of rodents fed non-GM food as part of the research project.

The disclosures come as European countries, including Britain, prepare to vote on whether the GM-modified corn should go on sale to the public. A vote last week by the European Union failed to secure agreement over whether the product should be sold here, after Britain and nine other countries voted in favour.

However, the disclosure of the health effects on the Monsanto rats has intensified the row over whether the corn is safe to eat without further research. Doctors said the changes in the blood of the rodents could indicate that the rat's immune system had been damaged or that a disorder such as a tumour had grown and the system was mobilising to fight it.

Dr Vyvyan Howard, a senior lecturer on human anatomy and cell biology at Liverpool University, called for the publication of the full study, saying the summary gave "prima facie cause for concern".

Dr Michael Antoniu, an expert in molecular genetics at Guy's Hospital Medical School, described the findings as "very worrying from a medical point of view", adding: "I have been amazed at the number of significant differences they found [in the rat experiment]."

Although Monsanto last night dismissed the abnormalities in rats as meaningless and due to chance, reflecting normal variations between rats, a senior British government source said ministers were so worried by the findings that they had called for further information.

Environmentalists will see the findings as vindication of British research seven years ago, which suggested that rats that ate GM potatoes suffered damage to their health. That research, which was roundly denounced by ministers and the British scientific establishment, was halted and Dr Arpad Pusztai, the scientist behind the controversial findings, was forced into retirement amid a huge row over the claim.

Dr Pusztai reported a "huge list of significant differences" between rats fed GM and conventional corn, saying the results strongly indicate that eating significant amounts of it can damage health. The new study is into a corn, codenamed MON 863, which has been modified by Monsanto to protect itself against corn rootworm, which the company describes as "one of the most pernicious pests affecting maize crops around the world".

Now, however, any decision to allow the corn to be marketed in the UK will cause widespread alarm. The full details of the rat research are included in the main report, which Monsanto refuses to release on the grounds that "it contains confidential business information which could be of commercial use to our competitors".

A Monsanto spokesman said yesterday: "If any such well-known anti-biotech critics had doubts about the credibility of these studies they should have raised them with the regulators. After all, MON 863 isn't new, having been approved to be as safe as conventional maize by nine other global authorities since 2003."

******************************************

5. When Fed to Rats it Affected their Kidneys and Blood Counts. So What
Might it do to Humans? We Think You Should be Told

Article from the Independent. Date: 22 May 2005
Geoffrey Lean
http://news.independent.co.uk/world/science_technology/story.jsp?
<http://news.independent.co.uk/world/science_technology/story.jsp?
story=640402

The secret research we reveal today raises the potential health risks of genetically modified foods. Here, environment editor Geoffrey Lean, who has led this paper's campaign on GM technology for the past six years, examines the new evidence. And he asks the questions that must concern us all: why is Monsanto, the company trying to sell GM corn to Britain and Europe, so reluctant to publish the full results of its alarming tests on lab rats? Why are our leaders so keen to buy the unproven technology against the wishes of consumers? And why is the man who first raised these concerns six years ago shunned by the scientific establishment and his former political masters?

One blustery day six years ago - at the start of The Independent on Sunday's successful GM campaign - I travelled to Aberdeen to meet a man who had been sent to Coventry.

Dr Arpad Pusztai was then the bogeyman of the British scientific establishment. No less a figure than Lord May - then the Government's chief scientific adviser, now president of the Royal Society - had accused him of violating "every canon of scientific rectitude", and ministers and top scientists had queued up to denounce him.

His crime had been to find disturbing evidence that the GM potatoes he was studying damaged the immune systems, brains, livers and kidneys of rats - and to mention it briefly in a television programme before his research was completed and published.

His punishment was draconian; his research was stopped, his team disbanded and his data confiscated (see box). He was ostracised by his colleagues, forced into retirement and gagged for seven months, forbidden to put his case. I was the first journalist to interview him at length, spending six hours with him.

I arrived, very sceptical, at his semi-detached house in the granite city, where he had worked for the prestigious Rowett Research Institute for 37 years, with two handwritten pages of hostile questions. But I was surprised by what I found.

For a start, he proved to be no wild-eyed maverick, but the world's acknowledged top authority in his field, a small, vital, precise man with 270 papers to his name and a self-deprecating sense of humour. Far from a headline-seeker, he was evidently a bewildered stranger to public controversy, cautious in his language, anxious to cross every scientific "t" before venturing a conclusion.

Perhaps most surprising of all he turned out to be, in his words, "a very enthusiastic supporter" of genetic modification who had fully expected his experiments - approved and funded by the Government - to give it a "clean bill of health".

"I was totally taken aback," he told me. "I was absolutely confident that I wouldn't find anything. But the longer I spent on the experiments, the more uneasy I became."

One by one he answered my questions. I can't say I was totally convinced, but I was persuaded of his integrity, and that he deserved a hearing. Grey-faced with the strain - and just recovering from a minor heart attack that he put down to it - he spoke of the "intolerable burden" of being attacked by the scientific community, without being able to defend himself, of being "vilified and totally destroyed".

As we walked to a nearby shop to photocopy some of his papers, he told me that he believed his troubles had started with a phone call to his employers, the Rowett Research Institute, from Downing Street. That really did seem incredible at the time - though rather less so now after the David Kelly affair and the revelations of the Hutton and Butler
inquiries.

Some supporting evidence for his suspicion since seems to have emerged (see box). But whatever the truth about that, this was a time when the Government was determined to press full-speed ahead with GM technology - and to rubbish him.

Tony Blair had just put his full weight behind modified foods, letting it be known that he would happily eat them himself. Jack Cunningham, then in charge of the Government's GM strategy, announced that Dr Pusztai had been "comprehensively discredited". His office drew up secret plans - revealed in The Independent on Sunday - to enlist "eminent scientists" to attack him and "trail the Government's key messages".

Worse, the Government refused to undertake the normal scientific process of repeating Dr Pusztai's experiments in order to either confirm or disprove his findings. Top officials at the then Ministry of Agriculture, Fisheries and Food told me that it would be "wrong", "immoral" and "a waste of money" to do so - an extraordinary attitude given the potential threat to public health, should he be right.

In the end all these official efforts were in vain. The public settled the argument simply by refusing to eat GM food. Before the Pusztai controversy, 60 per cent of processed foods on supermarket shelves contained GM material. After it the big chains fell over themselves to remove them in the face of the consumer revolt. Eighty-four per cent of Britons still say they will not eat them and even the most pro-GM ministers admit there is no market for them.

Attention then moved away from the health effects of GM food to the infinitely stronger evidence emerging on the environmental impact of GM
crops. Study after study - reported in our pages - showed that genes escaped from them to breed superweeds and to contaminate organic and conventional produce. Finally, the Government's own trials - widely expected to support GM crops - found that growing most of them damaged wildlife.

The biotech companies - in stark contrast to their confidence before the start of our campaign - abandoned their plans to grow GM crops in Britain. Six years ago they were awaiting imminent government approval to grow 53 different varieties of them. Not one of these applications now remains, and no new one is expected to be made in the near future. The Independent on Sunday's campaign has been widely praised for its key role in this volte-face.

Now, the focus is swinging back to GM foods - and their safety. The European Commission is pressing for more and more of them to be allowed to be sold in Britain and the rest of the EU. European governments are almost evenly divided for and against them and, in the resulting deadlock, the commission is using a loophole in the democratic process to nod them through one by one.

The latest modified crop to come up for approval for use in food is MON 863, a modified corn already grown and eaten in the US and Canada. On Thursday officials from EU governments were deadlocked again, making it likely that the commission will again wave it through later in the year.

It is particularly controversial because, as we report on page one today, secret research carried out on rats by Monsanto - which owns the corn - suggests that eating it may damage their health.

It indicates that rats fed relatively high levels of MON 863 had smaller kidneys and suffered potentially more harmful blood chemistry than those on a conventional diet. Monsanto dismisses the results as meaningless and due to chance, reflecting normal variations between rats.

Environmentalists, however, will claim that it partially vindicates Dr Pusztai's research, and Dr Beatrix Tappeser, a top German GM official, says that it gives "some reason for concern".

Apart from any possible implications for public health, the research data
- as in Dr Pusztai's experiments - are important because they could, if found to be valid, challenge the whole system by which GM foods are approved.

Regulatory bodies assume that if GM crops are similar to their conventional counterparts in a restricted number of ways - such as the amounts of fibre and fatty acids, protein and carbohydrates, vitamins and minerals they contain - then the chemical and genetic differences that do exist between them will not make them more toxic. They pronounce them "substantially equivalent" to non-GM ones and wave them through.

The official European Food Safety Authority, the Food Standards Agency in Britain and other regulatory agencies back Monsanto's view - as does most weighty scientific opinion. It would be extremely foolhardy to disregard their judgements and jump to alarming conclusions.

But it would be equally foolish to dismiss the few dissident voices. For I have found, time after time, in covering controversial environmental issues over the past 35 years, that lone scientists, stubbornly raising concerns in the teeth of entrenched opposition from industry and the scientific establishment, have often proved to be right.

Professor Derek Bryce-Smith of Reading University was ridiculed and marginalised for decades after warning of the dangers of lead in petrol in the 1950s - but it is now being phased out all over the world. The now much honoured Alice Stewart came under similar attack for first warning of the hazards of radiation to the unborn child. And I well remember one of Britain's top officials solemnly informing me a quarter of a century ago that Dr Irving Selikoff, who did more than anyone to sound the alarm on asbestos - now one of the main causes of premature death in Britain - was "evil".

I have sat in the august halls of the Royal Society and been told that acid rain caused by pollution did not exist. I have been lectured by one of Britain's top meteorologists - now travelling the world to warn about global warming - that the climate never changes, and that human activities could not possibly cause it to do so. And who can forget the constant reassurances from the political and scientific establishments that BSE could not spread to people?

A few weeks ago my teenage daughter asked me to test her on her environmental chemistry exam revision. As I checked her answers against the text book, I surprised her by letting out the occasional chuckle at its dry contents. For there, presented as indisputable fact, were many of these once highly controversial concerns raised by dissident scientists and roundly dismissed by the weight of scientific opinion.

It is still a long shot, and the balance of probability is still against it, but it is not impossible that in 25 years today's apparently alarmist concerns about the dangers of GM food will have found their way into a new generation of text books. If so, Dr Pusztai will finally come in from the cold.

The lone doctor who first exposed the risks to humans It was a startling and sensational claim - a claim aired on prime-time national television. Rats fed on genetically modified potatoes had suffered serious damage to their immune systems and shown stunted growth. This result, said Dr Arpad Pusztai, the scientist involved, was immensely worrying, since it raised substantial questions about the safety of GM food. "I find it is very unfair to use our fellow citizens as guinea pigs," he remarked.

Dr Pusztai's claims - broadcast by World in Action, one of the nation's most respected current affairs programmes - provoked one of the most intense scientific rows of the decade.

The backlash was orchestrated by ministers, led by Jack Cunningham, then New Labour's "Cabinet enforcer", and by the British scientific establishment.

Dr Pusztai, pictured, was a world authority on the subject, and his remarks, in August 1998, had come at a crucial time for Tony Blair. It ignited a public debate on the safety of GM foods, at a time when the Prime Minister was committing the UK to take a leading role in the bio- tech revolution.

That brief interview left Dr Pusztai's career in ruins.

That Monday evening, Professor Philip James, the head of Dr Pusztai's research centre, the Rowett Research Institute, had congratulated the Hungarian scientist on his television appearance.

Over the next 48 hours, Dr Pusztai and some of his colleagues allege that Professor James took two angry calls from Downing Street - a claim the professor denies. Yet by Wednesday, the Rowett had retracted Dr Pusztai's findings.

Its senior officials alleged the Hungarian had admitted he had misrepresented his findings. Rather than being fed GM potatoes, they claimed, the rats were given ordinary potatoes spiked with a protein which the extra genes might have made.

They also stated these were preliminary findings which had not gone through normal peer-review. In short, said Professor James, Dr Pusztai should not have gone public.

Dr Pusztai still refutes these charges. His study was funded by the Scottish Office's agriculture department. His research was designed to test the environmental safety of using GM potatoes with a toxin, lectin, added.

In 2001, he told a Royal Commission on GMOs in New Zealand it was the GM potatoes that produced the startling finding. The Rowett's tests showed that the GM potatoes were "significantly different" from normal potatoes. Yet, in May 1999, a panel of Royal Society-appointed toxicologists branded his research flawed.

And that was enough for Dr Cunningham to re-enter the debate. Dr Pusztai's findings were "not valid", he said.

But Dr Pusztai may yet emerge as a prophet. The revelations about Monsanto's secret GM corn research may confirm that this pro-GM scientist has become a hero of the anti-GM movement.

Severin Carrell and Andy Rowell

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6. Why the Mon 863 Study Should Have Been Rejected

Material provided by Professor Arpad Pusztai for Greenpeace press
conference. Date: 22 of June

The Mon 863 feeding study was poorly designed and reported. It is doubtful whether any prominent nutritional journal would consider it. It is odd, therefore, that it remains the key document used by government regulators to protect the health of European citizens.

Nutritional data missing: Nutrition studies require measurement and disclosure of the nutritional composition of the feed and the demonstration that it remains stable for the duration of the 90-day experiment. This assurance backed up by actual chemical analysis is not provided.

Methodology missing: The study fails to describe most of the methods used in the study. When methods cannot be evaluated or repeated, they remain suspect.

Older animals masked results: Nutritional studies use young, fast-growing animals, which are sensitive to toxic and nutritional effects. The study uses a mix of younger and more mature animals, which can mask serious problems.

Bizarre and conflicting animal weights: The starting rat weights given at two different places in the study were different. Thus, for male rats at the beginning of the report it was given as between 198.4 to 259.8 g while in Appendix 2, the values were 143 to 186 g. (similar differences for female rats). No high-class journal would tolerate such imprecision. Normally differences in starting weight should not be more than mean weight (typically about 80 g) ± 2%. Using such a wide range can make it impossible to find significant differences in animal weights at the end of the experiment.

The growth rates reported were inexplicable. During the experiment, for example, one rat lost 53 g in one week and then gained 102 g the next. Rats with the highest starting weight sometimes ended up with the smallest final weight. In the last four weeks, rats hardly grew at all, in spite of the similar feed intake and even though rats typically continue to grow throughout their lives. There is too little information provided to judge whether these are the result of animal mismanagement, degradation of the feed stored at room temperature, or some other problem.

Ignored modern methods: The analytical methods used are decades old.
Powerful new methods, such as various profiling techniques, DNA chips, proteomix, and others, were ignored. The 90-day length can also miss chronic problems, reproductive problems, and problems arising in subsequent generations. Also, the study relied on only two observation times, missing the rate of appearance (kinetics) of the changes.

Inappropriate and missing controls: The study¹s use of six irrelevant controls and reference to historical databases obscured the true findings. The study should have included a control group fed the non-GM parent line, spiked with the Bt gene product obtained from the GM maize, to isolate results of the transformation process. A second parental line spiked with a known toxin would also be useful as a positive control.

"Follow-up study" was inadmissible: Monsanto defended changes in kidney weights by comparing results from the test animals with rats used in a completely different study, conducted in a different laboratory, using Mon 863 hybrids with other GM maize samples. In this study the results of the original MON 863-study was quoted (but not actually re-done) for comparison. This inter-experimental comparison is entirely inappropriate for nutritional evaluation and should be disregarded.

Nutritional scientists and leading journals would not accept these blatant inadequacies and misinterpretations. How can regulators accept it for a novel genetically modified food?