U.S. Study Says All Clones Genetically Abnormal

By Maggie Fox

WASHINGTON, Sept 11 (Reuters) - Cloned mice have hundreds of abnormal genes, which explains why so many cloned animals die at or before birth and proves it would be irresponsible to clone a human being, scientists said.

The process of cloning introduces the genetic mutations, and there seems no immediate way around the problem, Rudolf Jaenisch and colleagues at the Massachusetts Institute of Technology reported.

"I think this confirms suspicions that I have always had and that many others had that cloning is a very inefficient method at this point," Jaenisch said in a telephone interview.

"It is very irresponsible to think this method could be used for the reproductive cloning of humans."

Even before Dolly the sheep became the first mammal to be cloned from an adult cell, in 1997, researchers have known that cloning is difficult.

The most common cloning method is called nuclear transfer and involves taking the nucleus out of an egg cell, replacing it with the nucleus from a cell of the animal to be cloned, and then "reprogramming" the creation so the egg begins dividing as if it had been fertilized by a sperm.

Only one of every several hundred eggs ever start dividing and of these, only a small percentage result in pregnancies. Many of the animals that survive to birth die soon after, or develop abnormalities of the lung, liver and other organs.

Jaenisch and colleagues at MIT's Whitehead Institute, working with Ryuzo Yanagimachi of the University of Hawaii, who was the first to clone mice, made dozens of cloned mice and then looked at the activity of 10,000 genes using a gene chip.

Writing in this week's issue of the Proceedings of the National Academy of Sciences, they looked mostly at the placentas of the newborn mice, long assumed to be the source of the problem, but also at the livers of some of the clones.

Gene Chip Shows Abnormal Genes

They found many abnormal genes. The pattern was so clear that they could tell normal mice from cloned mice by looking at the results of the gene chip study, they reported.

"There is no reason in the world to assume that any other mammal, including humans, would be different from mice," Jaenisch said.

He said the finding should convince anyone who doubted the danger of trying to clone a human, referring to last summer's debate between he and other cloning experts, and three scientists who said they planned to try to clone human babies to help infertile couples.

"It settles the old question ... about how normal can clones be," Jaenisch said.

The three scientists have each said they are on the verge of creating a cloned baby but none has produced evidence that convinces scientists such as Jaenisch.

The issue has been debated in the U.S. Congress and competing bills would outlaw attempts to clone a human being, and some would outlaw using cloning technology in human beings at all.

Several cloning researchers have said their cloned livestock, such as cattle, sheep and pigs, are normal and healthy if they get past birth.

Jaenisch believes genetic abnormalities will be found even in these seemingly normal animals. Some of the abnormalities are simply not fatal, he said.

Many of the problems the team found were in so-called imprinted genes, involved in the development of the embryo. In the imprinting process only the copies of a gene that a baby gets from its father are turned on.

"Almost 50 percent of those were incorrectly expressed," Jaenisch said.

That may mean that so-called therapeutic cloning, which uses cloning technology to make human cells for use in medical treatments, would be safe, he said.

"In therapeutic cloning you don't form an embryo," Jaenisch said, noting it went to an early stage of development in which a ball of about 100 cells is formed.

"In cloning most, if not all, problems arise during embryonic development," he added.

Landmark Scientific Finding: GE Animals Pose Serious Risks to Human Health, Environment

For Immediate Release
August 20, 2002
Contact:
Joseph Mendelson, Center for Food Safety
(202) 547-9359
Matt Rand, National Environmental Trust
(571) 241-8072 cell(202) 887-8841

WASHINGTON, D.C. - Consumer and environmental advocates today described a new study by the National Academy of Sciences (NAS) as recognizing the serious human health, environmental and ethical concerns associated with the use of genetically engineered (GE) animals in the food supply. In particular, the organizations stated that the NAS' findings supported their legal efforts seeking a moratorium on the approval and pending release of GE salmon.

"This study effectively ends the debate in this country over whether GE animals pose a risk to human health and the environment," said Matt Rand, Biotechnology Campaign Manger for the National Environmental Trust. "The U.S.'s leading impartial scientific body has spoken, and the American people have reason to be concerned."

The study, Animal Biotechnology: Identifying Science-Based Concerns, was released earlier today at a briefing for congressional staff on Capitol Hill in Washington DC. It finds that commercially introducing GE animals into the U.S. food supply would pose serious risks to human health, including:

The report also found several risks to the environment, including:

Specifically, the report found of particular concern the potential use of new genetically engineered salmon with the ability to grow four to six times faster than its wild relatives. The NAS recognized that GE salmon could severely impact their wild relatives, the already-endangered Atlantic salmon. Other studies have found that if GE salmon are introduced into aquaculture facilities they will escape and could potentially eradicate wild salmon in a few short generations

Commercial approval of GE salmon is currently under consideration by the Food and Drug Administration (FDA). In May 2001, the Center for Food Safety, GE Food Alert and over sixty other environmental and consumer organizations filed legal petitions with four federal agencies, including the FDA, seeking a moratorium on the use and commercial sale of GE fish. The legal petition is still pending before the FDA.

"The report recognizes that there are many risks and virtually no controls protecting the environment or the public from the potential impacts of genetically engineered animals," said Joseph Mendelson, Legal Director of the Center for Food Safety (CFS). "The FDA should heed this warning and halt any approval of genetically engineered fish."

The uncertainty of identifying problems early and the difficulty of remediation once a problem was identified led the NAS to deem the potential for major environmental impacts the most serious and immediate.

"Each new genetically engineered animal developed has the potential to become an invasive species and disrupt the stable environmental predator/prey balance," said Rand.

Super Crops Lead To Super Weeds

By Oliver Moore
Globe and Mail Update
Thursday, August 8

Scientists say they have confirmed what farmers have suspected for years, that genes introduced into plants can migrate to nearby weeds, possibly making them stronger and more resistant to chemicals.

In what is being billed as a ground-breaking discovery, U.S. scientists in three states have shown that sunflowers modified with an artificial gene designed to help ward off pests can spread that ability to wild sunflowers.

Scientists bred wild sunflowers with cultivated sunflowers containing the transgene Bt — taken from the soil-dwelling bacterium Bacillus thuringiensis, which produces chemicals poisonous to some insects.

The hybrid sunflower that resulted was found to have 50 per cent more seeds and far less insect damage than the control group.

"This is the first example of what might happen if a beneficial transgene accidentally spread to a wild population and then proliferated in subsequent generations," said study co-author Allison Snow, a professor of evolution, ecology and organismal biology at Ohio State University. "We were surprised that a single transgene (foreign gene) could have such a big effect on seed production."

Saskatchewan farmer and anti-genetically modified organism (GMO) campaigner Percy Schmeiser was frankly disbelieving that this was not already known. He told globeandmail.com that Prairie farmers are all too familiar with the ill effects of genetic modification.

"You cannot control it once it's released into the environment," he said Thursday. "It will contaminate, and you will lose your pure seed."

The veteran of a lengthy patent battle with global chemical giant Monsanto, Mr. Schmeiser says that a court ruling has left him unable to plant canola — a crop he developed and grew for more than 50 years — unless he can prove that it does not include Monsanto's altered canola seeds. And that proof is impossible, he says angrily, because farmers have found that all seed has been contaminated.

"We have reports even of canola that is resistant to even 2,4-D," he said, referring to a powerful herbicide first sold in the late 1940s that would normally "knock the hell out of canola."

"It's an issue of superweeds. They never realized that it could happen, and it happened within two or three years."

Ms. Snow acknowledges the possible dangers of spreading GMOs, noting that "weeds are already hardy plants; the addition of transgenes could just make them tougher."

And a statement from the research team admits that "if a wild relative grows near a crop plant, chances are good that the two will crossbreed."

Ms. Snow also acknowledged that adding genes to a plant's DNA could hamper its ability to reproduce, while possibly also causing modified weeds to spread faster.

The team, which included researchers from the University of Nebraska and Indiana University, was scheduled to present its findings Thursday to the annual Ecological Society of America in Tucson.

Ms. Snow says that further research will be needed to see whether wild sunflowers that pick up foreign genes could become troublesome weeds.

Follow-Up News:

Big Seed Companies Quash Basic Research on GE Crops

For Immediate Release
October 30, 2002
Contact: Neil Carman, Ph.D. 512-472-1767
Jim Diamond, M.D. 510-527-4130

Sierra Club has asked Pioneer Hi-Bred (a Dupont company) and Dow Agrosciences (a division of Dow Chemical) to reverse their recent decision to withhold seeds and genetic material from an Ohio State researcher whose findings indicated that their products could be harmful to the environment. "It's outrageous that these companies claim that their products are thoroughly tested and good for the environment but throttle research when the results go counter to their PR message," said Laurel Hopwood, Chair of Sierra Club's Genetic Engineering Committee.

Dr. Allison Snow's research was originally funded by the two companies and the USDA. The Ohio State researcher showed that the genes which had been genetically engineered into sunflowers could persist in the wild and give rise to "superweeds." She wanted to continue her research without company funding but the companies -- which control the patented seed -- will not allow her. Details were released to the broader scientific community earlier this month by an article in the prestigious journal Nature.

"If patent protections are used to stop scientific study, new legislation to restrict such patent rights should be urgently considered," according to the Sierra Club letter, which was sent also to several law makers including Rep. Kucinich of Ohio who has sponsored "right to know" legislation to require labeling of genetically engineered food, and to Sen. Harkin, Chair of the Senate Agriculture Committee.

Patent protection for genes, the blueprints for life, have only been granted since 1980. Those critical of the practice, including Sierra Club, say that allowing patents on the molecular machinery of life is turning important aspects of the natural world into the private property of a few.

GM Cotton Damaging the Environment

Xinhau News Agency

BEIJING, June 3 (Xinhuanet) -- A genetically modified cotton plant which makes up 35 percent of China's crop, is damaging the environment despite its success in controlling the bollworm pest, according to a report released here Monday.

The plant, Bt transgenic cotton, was harming natural parasitic enemies of the bollworm and seemed to be encouraging other pests, according to the study by the Nanjing Institute of Environmental Sciences (NIES) under the State Environmental Protection Administration (SEPA) at a seminar here.

Researchers have seen a significant decrease in populations of the bollworm's parasitic natural enemies.

Bt transgenic cotton, containing anti-bollworm genes from certain bacillus, is in large-scale commercial production in Chinaand the planting area was estimated to top 1.5 million hectares last year, accounting for about 35 percent of the total cotton area, according to the Cotton Research Institute under the Chinese Academy of Agricultural Sciences.

The report says that the diversity index of the insect community in the Bt cotton fields is lower than conventional cotton fields while the pest dominant concentration index is higher.

The balance of the insect community is weaker in Bt cotton fields than the conventional crops as some kinds of insects thriveand this is more likely to cause outbreaks of certain pests, said Xue Dayuan, the NIES expert in charge of the report.

Populations of pests other than cotton bollworm has increased in Bt cotton fields and some have even replaced it as primary pests because the GM plant is slow at controlling those pests, thereport says.

Scientists also verified with lab tests and field monitoring that cotton bollworm will develop resistance to the GM cotton and concluded that Bt cotton will not resist bollworm after being planted for eight to ten years continuously.

New GM organisms and products would benefit agriculture and many other industries, but people should always beware of the long-term and underlying impacts on the environment, said Zhu Xinquan, chairman of the Chinese Society of Agro-Biotechnology that jointly hosted the seminar with the NIES and Greenpeace China.

GM organisms will pass new genes borrowed from different species to local plants and creatures through reproduction when it's put into the natural environment, changing the natural gene structures, said Isabelle Meister, an expert from Greenpeace International, the international environmental campaign group.

"The changes are irreversible and the loss is likely to be damaging as the genes in nature, mostly existing in wildlife and some small regional species, are useful for people to develop new species of plants and animals with high quality or against certaindisease," she said.

China is a center for diversity of several plants like soy bean and faces the problem of how to protect its original genes from imported GM products, Meister said.

GM Safety Tests 'Flawed'

BBC News
April 27, 2003

Safety tests on genetically modified maize currently growing in Britain were flawed, it has emerged.

The crop, T-25 GM maize, was tested in laboratory experiments on chickens.

During the tests, twice as many chickens died [8 PERCENT] when fed on T-25 GM maize, compared with those fed on conventional maize [3.8 PERCENT].

This research was apparently overlooked when the crop was given marketing approval in 1996.

Lord Alan Gray, who chairs the government's advisory committee on releases to the environment, voiced his concerns about the tests to BBC Radio 4's Farming Today programme.

He said the safety tests had not been good enough to give a real picture of the risks involved in marketing T25 GM maize.

But, following an investigation by BBC Radio 4's Farming Today programme, Acre's chairman Lord Alan Gray admitted he believed the research should have been re-analysed and that safety tests were not good enough to give a true picture of the risks involved.

T-25 was first approved by the French authorities, then the rest of Europe in 1996 but it was only when it reached the seed listing stage that doubts began to be raised.

T-25 GM Maize is being grown throughout the UK as part of the government's field crop trials and is intended to be used as cattle feed.

Dr Stephen Keston, a senior researcher at the department of veterinary sciences at Bristol Veterinary School, studied the initial tests.

'Thin science'

He said they were "not really good enough to base a student project on, let alone a marketing consent for a GM product".

"It does surprise me that we have got so far down the line of licensing a GM crop apparently based on very weak and thin science," he said.

When the marketing consent was granted there were only two animal studies relating to T25 available to the approval committees - one on rats and one on chickens - and both have subsequently been criticised by independent scientists.

Dr Gray was on the committee that gave the original consent.

He said advice given to the panel from its experts had initially said there was "nothing in any of the data they looked at which made them believe there was a risk to the animals, humans and the environment from feeding this product".

Fears

But he admitted it may have been better to re-analyse the chicken feeding tests, given the doubts raised.

Peter Ainsworth, shadow secretary of state for the Department for Environment and Rural Affairs (Defra), is calling for an overhaul of the whole approvals process for GM crops.

In January, the government announced 44 more sites across the country would be used for farm trials of genetically modified oilseed rape and beet.

Campaigners, including Friends of the Earth, have long argued against the trials and expressed fears about safety.

Several times trial fields have been taken over by protesters who have uprooted the experimental plants in order to prevent what they describe as contamination of other crops and wild species.

Still More on the Mexican GM Maize Scandal:

News Release:
ETC Group (formerly RAFI)
April 4th, 2002

Nature magazine's flip-flop today over the testing protocols involved in determining GM maize contamination in Mexico - the Centre of Genetic Diversity for the vital food crop - is just the latest in a string of absurdities as the scientific community struggles over what to do as genetically-modified germplasm invades the genetic homelands of the world's food supply.

De-naturing Nature:

Nature magazine - arguably one of the world's most influential peer-reviewed science publications - in an editorial note today, states that contrary to its report of November 29th, 2001, "...the evidence available is not sufficient to justify the publication of the original paper." In other words, farmers' fields in Oaxaca and Puebla have not proven to be contaminated with GM maize. The current issue of Nature contains two articles by scientists refuting the original contamination claims and a reply from the two scientists who authored the original peer-reviewed report. David Quist and Ignacio Chapela of the University of California at Berkeley stand by their study and add that other studies by the Mexican Government confirm their findings.

Blind-siding Biodiversity:

Nature's double take couldn't have come at a better time for the biotech industry. Next Monday, more than 150 governments and equal numbers of civil society organizations will gather in The Hague, Netherlands for the tenth anniversary meeting of the UN Convention on Biological Diversity (CBD - April 8 - 26). A moratorium on Terminator technology, the protection of forests, and discussions around a just-completed treaty on plant genetic resources are all on the agenda. The case of GM contamination in Mexico was bound to be on the minds of many delegations. The final week of meetings is set aside to review progress on the Cartagena Biosafety Protocol adopted two years ago. The elements of that protocol and its crucial Precautionary Principle would bring the Mexican scandal to the fore as well. "If the CBD can't act on the Mexican situation, if governments cannot agree that the Precautionary Principle applies in this case," says Silvia Ribeiro of ETC, "then there is little hope that this ten-year old Convention serves any useful purpose." Nature's editorial could have the effect of de-fusing and confusing governmental concern.

Withholding Evidence?

The scientific battle raging since at least last September has been over the efficacy of the testing processes. There has been almost no substantive discussion of the likelihood or the implications of GM contamination. In fact, most maize scientists agree that contamination is highly likely and inevitable given the breeding habits of the crop.

Meanwhile, Mexican farmers and other civil society organizations are impatiently awaiting two overdue new reports on the situation commissioned by the Mexican Government. It now appears that political pressure is being applied within the Government to delay publication until after the international conference in The Hague. Although the Secretary of Environment of Mexico, through its Institute of Ecology (INE) contracted two institutions to undertake new tests, the results have been excessively delayed. According to CSOs in Mexico City, the testing done to date all confirms the original Berkeley study.

Precautionary Practices:

Civil Society Organizations gathered at the World Social Forum in Brazil wrote on February 6th to both the Consultative Group on International Agricultural Research (CGIAR) and to the UN Food and Agriculture Organization (FAO) asking them to take action with respect to Mexican maize contamination. The CGIAR's flagship institute, the International Maize and Wheat Improvement Centre (CIMMYT) is just outside Mexico City and is deeply embroiled in the transgenic contamination debate.

In a reply dated February 13th, CGIAR expressed concern but declined to take any specific steps. The global network of public research institutes is partly funded by the U.S. Government and is negotiating a number of technology licensing agreements with the biotech industry. "One official told us that the issue was just too hot politically for the CGIAR to get involved," Pat Mooney of ETC group notes.

FAO has been more forthcoming. In a letter dated March 22nd, FAO acknowledged that the situation was serious and reported that the UN agency - in contrast to CGIAR - has requested CIMMYT to investigate the implications for genetic diversity in Mexico and any possible consequences for CIMMYT's maize gene bank. The world's most important international maize collection is held in trust by CIMMYT under the auspices of FAO. FAO expects CIMMYT to report on the situation when its intergovernmental commission meets in Rome this October. Further, FAO is developing a Code of Conduct on Biotechnology and the issues of GM contamination in Centres of Crop Genetic Diversity will now be part of the agenda.

Biodiversity's Bottom line:

"The whole debate in Nature is an obfuscation of the real issue," Hope Shand of ETC group says, "Maize breeders and geneticists all know that GM introgression with traditional farmers' maize varieties in Mexico is inevitable and most are convinced that it has already taken place. Whatever the status of the various studies, the reality is that a Centre of Crop Genetic Diversity has been contaminated and no one is doing anything about it. We realize that some scientists do not consider the contamination to be a problem. We disagree. Regardless, we all agree - even CIMMYT - that rigorous study of the implications is needed. In the meantime however, there must be a complete moratorium. The CGIAR should stop stalling and get with the programme!"

Study Questions Safety of Genetically Engineered Foods

To: National Desk
Contact: Dr. Barry Commoner of the Center for the Biology of Natural Systems
718-670-4182

NEW YORK, Jan. 15 /U.S. Newswire/ -- A study released today reveals a critical, long-overlooked flaw in the science behind the multi-billion dollar genetic engineering industry, raising serious questions about the safety of genetically engineered foods.

In a new review of scientific literature reported in the February issue of Harper's Magazine, Dr. Barry Commoner, a prominent biologist demonstrates that the bioengineering industry, which now accounts for 25-50 percent of the U.S. corn and soybean crop, relies on a 40-year-old theory that DNA genes are in total control of inheritance in all forms of life. According to this theory -- the "central dogma" -- the outcome of transferring a gene from one organism to another is always "specific, precise and predictable," and therefore safe.

Taking issue with this view, Commoner summarizes a series of scientific reports that directly contradict the established theory. For example, last year the $3 billion Human Genome Project found there are too few human genes to account for the vast inherited differences between people and lower animals or plants, indicating that agents other than DNA must contribute to genetic complexity.

The central dogma claims a one-to-one correspondence between a gene's chemical composition and the structure of the particular protein that engenders an inherited trait. But Dr. Commoner notes that under the influence of specialized proteins that carry out "alternative splicing," a single gene can give rise to a variety of different proteins, resulting in more than a single inherited trait per gene. As a result, the gene's effect on inheritance cannot be predicted simply from its chemical composition -- frustrating one of the main purposes of both the Human Genome Project and biotechnology.

Commoner's research sounds a public alarm concerning the processes by which agricultural biotechnology companies genetically modify food crops. Scientists simply assume the genes they insert into these plants always produce only the desired effect with no other impact on the plant's genetics. However, recent studies show that the plant's own genes can be disrupted in transgenic plants. Such outcomes are undetected because there is little or no governmental regulation of the industry.

"Genetically engineered crops represent a huge uncontrolled experiment whose outcome is inherently unpredictable," Commoner concludes. "The results could be catastrophic."

Dr. Commoner cites a number of recent studies that have broken the DNA gene's exclusive franchise on the molecular explanation of inheritance. He warns that "experimental data, shorn of dogmatic theories, point to the irreducible complexity of the living cell, which suggests that any artificially altered genetic system must sooner or later give rise to unintended, potentially disastrous consequences."

Commoner charges that the central dogma, a seductively simple explanation of heredity, has led most molecular geneticists to believe it was "too good not to be true." As a result, the central dogma has been immune to the revisions called for by the growing array of contradictory data, allowing the biotechnology industry to unwittingly impose massive, scientifically unsound practices on agriculture.

"Dr. Commoner's work challenges the legitimacy of the agricultural biotechnology industry," said Andrew Kimbrell, Director of the Center on Food Safety. "For years, multibillion dollar biotech companies have been selling the American people and our government on the safety of their products. We now see their claims of safety are based on faulty assumptions that don't hold up to rigorous scientific review."

The study reported in Harper's Magazine is the initial publication of a new initiative called The Critical Genetics Project directed by Dr. Commoner in collaboration with molecular geneticist Dr. Andreas Athanasiou, at the Center for the Biology of Natural Systems, Queens College, City University of New York.

Scientists Signal GM Food Setback

by Nick Drainey
The Scotsman
February 5, 2002

SUPPORTERS of genetically modified foods were dealt a damaging blow yesterday as the UKs leading body of scientists produced an unexpectedly critical report on the contentious issue.

The Royal Society acknowledged public concerns over GM foods, calling for tougher regulations before they were passed as safe to eat. It also recognised the potential dangers to the health of babies, who are particularly vulnerable to changes in the nutritional content of their food.

It recommended re-examining UK and European Union law to ensure rigorous testing of any GM ingredients considered for use in infant formula.

Environmentalists, who had expected a more pro-GM stance, said the report represented a major U-turn by the scientific community. The study, which reviewed GM health risk evidence to emerge over the last three years, concluded there was "no reason" to doubt the safety of foods made from GM ingredients. But it recommended improvements in the methods used to assess the safety of GM foods - and recognised the industry had failed to assuage the publics safety fears.

Professor Jim Smith, from the Wellcome CRC Institute in Cambridge, who chaired the working group which produced the report, said: "We fully support the publics right to know that all new foods, regardless of whether they contain GM ingredients, are subjected to rigorous safety and nutritional checks.

"The rather piecemeal approach to the regulation of GM foods in the UK and EU in general means that there may be some important gaps and inconsistencies."

The report said the system should be made "more explicit and objective" and harmonised throughout the EU.

Prof Smith added: "What we think is terribly important ... is that the criteria for the comparisons be made explicit, objective and comprehensive. These three things need to be done."

The Royal Society said using DNA from viruses in the genetic engineering of plants posed a "negligible" health risk. It also dismissed the alleged risks associated with eating and digesting modified plant DNA.

But the report did recommend that allergy screening of all new foods, whether or not they contain GM ingredients, should be extended to include inhaled material. At present, tests are only carried out for material that is eaten. The scientists said there were also potential risks of allergic reactions from breathing in pollen, spores and dust. Prof Smith said: "We have looked at all of the available research and found nothing to suggest the process of genetic modification makes potential foodstuffs inherently unsafe."

Adrian Bebb, GM campaigns director at the environmental group Friends of the Earth, said the scientific establishment had at last woken up to public concern about GM food.

"Its quite a big U-turn for them because they've had a very pro-GM viewpoint in the past," he added. "I think this report confirms all the concerns raised over the last few years.

"There isnt a proper food testing system in place. We dont know what the long-term impact of GM foods are. We dont know if they're going to cause lots of allergies and we dont know about their impact on children. The tests have got to be dramatically improved." Green Party MSP Robin Harper said: "The Royal Society has clearly stated GM technology could lead to unpredictable harmful changes in foods and that vulnerable groups, including infants, are particularly at risk under the current safety testing procedure."

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