25 November 2000

Table of Contents

India Says No to Genetically Modified Food
South Afica: Conference wants moratorium on genetically modified foods
WTO: Seedy Squabble in Switzerland
Forbes Magazine: "Corporate Saboteurs go mainstream"
EPA may be wrong judging toxicity of GE food
URL: Insanex managed to provoke EuropaBio to the extend of legal threats
Xenotransplantation: New company for humanized pigs
US: Legal issues of biotech questioned
Credit Suisse warnes: Time is running out for the biotech industry
resistance to Bt in bollworm
Biotech report dubbed 'worthless'
NZ: Comstock and The Life(r) SciencesA PRgang
Sheep growth accelerated by GE lupins
cloned animals need fuller study

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Date: 20 Nov 2000 02:25:56 U

India Says No to Genetically Modified Food

XINHUA via NewsEdge Corporation, November 20, 2000

NEW DELHI - Genetically modified seeds and food would not be allowed into India till their safety is scientifically proved, Agriculture Minister Nitish Kumar said on Saturday.

According to the Press Trust of India (PTI), Kumar said in Calcutta, 1, 460 kilometers southeast of here, that there is a lot of apprehension about genetically modified seeds and food in the country.

"We can not allow import of things which are not acceptable to the people. Let health and environmental scientists decide how safe those are," the minister added while inaugurating a regional plant quarantine center near Calcutta.

Declaring that the central government has decided not to allow entry of "terminator" seeds into the country, Kumar said that while his country is aimed at becoming a superpower in bio- technology, the concerns of the people must also be addressed.

Warning that there has been a "globalization of pests," he called on Indian scientists to remain vigilant to check the entry of harmful exotic pests and germs into agricultural produce of the country.

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Date: 20 Nov 2000 13:45:18 U

S/Afica: Conference wants moratorium on genetically modified foods

Friday, November 17, DURBAN, South Africa, (AFP)

Delegates at the 16th World Congress of Consumers International here Friday called for a moratorium on growing and marketing genetically modified (GM) foods until they are subject to stricter safety checks.

The 650 delegates – wrapping up a five day meeting – also called on those countries that produce GMs not to intimidate other governments which resist or prohibit GM products.

Brazilean lawyer Andrea Lazzarini, who stopped GM producer Monsanto from introducing its modified soyabean seed in that country, said civil society could play a big role in helping governments to resist pressure exerted on multinational companies.

"One of the best strategies is for consumers to boycott GM foodstuffs," he said.

Lazzarini said he believed consumer action forced the recent decision of another big GM producer – Novartis – to pull out of GM seed production.

Doctor Suman Sahai of India's Gene Campaign, said science too had role to play in the fight against GM foodstuffs as it could police their safety.

"Proof is growing that our fears about irreversible damage to the environment caused by genetic modification to foodstuffs is well-founded," he said.

Michael Hansen from the United States' Consumers Union warned that most of the maize and corn in that country was already genetically modified.

"New US regulations eliminating certain export controls means that GM corn/maize may be making its way into food products and food aid sent around the world."

He called for stricter control and checking, saying this was the job of not only governments but of the world's consumer organisations.

"It is up to governments and consumer organisations to ensure that GM foods are monitored and controlled." he said.

Delegates in the east coast city of Durban also adopted a statement that all people have the right to safe and sufficient food.

In order to protect this right, they said, governments and international agencies should ban the use of patents on food products.

Such patents, they said, could impede people's access to food and increase the dependency of developing economies on developed ones.

Earlier this week, delegates heard that the use of patents on medicines, and the protection this practice enjoys from international organisations, was keeping desperately-needed drugs beyond the reach of the sick and poor in developing countries.

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Date: 20 Nov 2000 18:26:54 U

RAFI News Release Monday, November 20, 2000

WTO: Seedy Squabble in Switzerland

By Pat Mooney (in Bolivia), Telephone: (59) 1 644-0016, E-mail:
Silvia Ribeiro, E-mail:

As Washington tries to sort out what a "plant" is, world food security is iced in Switzerland. Industry, Europe, Japan, and the G77 (developing) countries look on in amazement.

What "grows" but doesn't "move"? If you're an agronomist, the standard answer is a "plant". In Neuchatel, Switzerland last week however, at a tactically critical food security negotiation, the running joke was "Washington trade policy". As world seed and biotech industries, governments of Europe and Japan, and G77 (developing) countries watched in consternation, U.S. Government representatives tied themselves in knots trying to explain the difference to disinterested patent and trade lawyers back in their capitol, between plant genetic resources in agriculture from other industrial technologies. The U.S. delegation continuously raised what appeared to other delegations, to be nonsensical conflicts between the World Trade Organization (WTO) and an agreement being revised by governments in the UN Food and Agriculture Organization (FAO) to safeguard the flow of crop germplasm for scientific research and international food security.

Plant plots?: Biocrats (bureaucrats in the interrelated agro, biotech, and biodiversity arena) from 40 governments met in Neuchatel Nov.12-17 to update and make legally-binding an International Undertaking that would guarantee a continuing flow of scientific breeding material between countries, and ensure the conservation and development of the plant genetic resources for future generations. At stake were several million seed samples – mostly contributed by poor farmers in developing countries. Despite (some say because of) advances in biotechnology, farmers' traditional seeds form the backbone of plant breeding to fend off new diseases and to allow world agriculture to adjust to global warming. As always, one of the stumbling blocks in negotiations, begun in 1994, is money. Who's going to finance an international network of gene banks to hold the endangered seeds and how will the South (developing countries) benefit from the donation of their invaluable seeds?

Seedy "saviors"?: At their previous meeting in Tehran in August, governments were able to accept a proposal that came from an unexpected source. An association including the world's major plant breeding and agricultural biotechnology companies offered to foot at least a small portion of the bill (the total is estimated at between $200 and $350 million per annum) by agreeing to pay a fixed share of the royalties companies derive from seed patents based on the germplasm that would flow through a multilateral system of 'facilitated access' to be established as one part of the new treaty. While many countries and advocacy organizations object strenuously to "life patenting", the unambiguous message to OECD governments that industry needs a deal and must have open scientific circulation of breeding stock warned country reps that they too should get on side and ante up the needed funds.

In the Tehran meeting, the United States indicated its general support for the industry proposal and agreed to allow its adoption without the famous "square brackets" that warn of unresolved issues during negotiations. (The treaty text is festooned with the troublesome brackets.) The U.S. did say however, that they would have to consult back in Washington.

Suddenly in Neuchatel, the Americans announced that they could not accept the industry proposal and wanted brackets. According to the embarrassed biocrats, Washington trade representatives following the WTO were concerned that a treaty tithing industry would conflict with trade rules regarding non-discrimination between different technologies. The delegation also hinted that there might not be a full consensus within company circles on the royalty payment.

Four made foolish: The representative of ASSINSEL – the seed industry trade association headquartered in Nyon, Switzerland was stunned. ASSINSEL had consulted with its member companies both globally and region by region including in North America. With respect to a possible conflict with trade agreements, the WTO official in the meeting, while acknowledging that any challenge to the deal could only be resolved by a WTO dispute settlement process seemed dubious of any problem. An independent legal consultant under contract to FAO delivered a detailed opinion that convinced virtually everyone that there was no conflict. An African diplomat later told RAFI that the only countries that were likely to challenge the agreement through the WTO were already at the table agreeing to the text.

The strange U.S. refusal to go along with other countries – and their insistence that seed/biotech companies in the USA are opposed to royalty tithing – was made more confusing Friday when rumours circulated that a major Gene Giant, such as Monsanto or Dupont, will announce before the end of November a plan to "tithe" by investing in global food security. "No doubt the company will try to grab headlines for its commitment to feed the world's hungry," comments Silvia Ribeiro of RAFI – who attended the Neuchatel session as a civil society observer. "But there is already general agreement within industry that there must be a mechanism to compensate the South for its germplasm – the cornerstone of global food security," said Ribeiro.

Nevertheless, and despite a session that dragged late into Friday night, the U.S. delegation refused to budge. Canada, Australia, and New Zealand were drawn into solidarity with the USA. European countries - EU and otherwise – closed ranks against the "foolish four" and were joined by the G77, China, and by Japan as well. The Japanese, perhaps the most publicly outspoken delegation, apparently warned the U.S. that their position could destroy the negotiations.

High priests of patents: The Neuchatel meeting collapsed, and its chair Ambassador Fernando Gerbasi of Venezuela, left the gathering to fly to Rome to report to the FAO governing Council whose sessions began today and run all week. Gerbasi, a vigorous and passionate advocate for world food security and long-concerned for the pivotal role of crop genetic resources conservation, will be looking to the Council for advice on how - or whether – the talks should continue. Leaving Neuchatel, many biocrats expressed their anger with the stance taken by the United States, Canada, and Australia especially. "The U.S. diplomats know that there is no problem," one delegate, who asked not to be identified, told RAFI, "They just couldn't get their trade people in Washington to pay attention. Those people think a plant is some kind of industrial manufacturing facility." Another European delegate added, "The Canadian delegation was obviously split and embarrassed over this issue. They k!

now there is no problem but they sided with the Americans to give them time to work out their differences in Washington. Typical Canadian diplomacy," he concluded with disdain. An African biocrat was particularly scornful of the Australian position, "The U.S. will come on side eventually," he assured, "but the Australians are impossible. They are the nasty people. They know the U.S. has got it wrong and they're exploiting the confusion to sabotage the talks." "The only useful thing we've learned here," another diplomat said, "is that what we suspected all along is actually true. The trade and patent people in Geneva and in our capitols haven't any idea about the impact they are having on food security or the environment. They only know about commodities, textiles, and CD copyrights. The emperor's have no clothes!" he concluded.

Rome resolution: The clear message from Europe and Japan following Neuchatel was that the negotiations should continue and that the pace, if anything, should be quickened. "We need another meeting in February," said one delegate. "That will give the high priests of patents in Washington time to figure out what a plant is. The Australians can stay home if they want. The Canadians will come running behind the Americans and the crisis will be over." The G77 and Europe will be working this week to get a firm resolution out of the FAO Council calling for governments to be reasonable and for the talks to proceed. It's short notice for that kind of diplomatic maneuver. Officials in Rome will also call for governments to be represented in the negotiations at a higher political level in order to avoid further humiliations like that experienced by the United States. "This may seem like a tempest in a teapot," an Asian delegate concedes. "Most diplomats, most people, don't understand how dependent the world's food supply is on the flow of plant genetic resources. This is a tempest in our rice bowl – and that's important!"

For further information:

Pat Mooney (in Bolivia): Telephone: (59) 1 644-0016 E-mail:

Silvia Ribeiro E-mail:

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Date: 21 Nov 2000 05:56:29 U

An excellent summary of the inevitable.



"A few years ago biotech companies dismissed their enemies as Greenpeacers and Luddites. Not any more. Now there's a widely supported moratorium on new imports of genetically modified foods in Europe and a very similar sentiment running through the middle of America. Protesters certainly caught Monsanto flatfooted, lopping $8.6 billion off its market value, so weakening the company it was forced into a shotgun marriage with Pharmacia. The attack on Monsanto's seeds, coupled with the recent store-shelf panic over unapproved corn, probably set back crop biotechnology a decade."

Forbes Magazine: "Corporate Saboteurs go mainstream"

By Robert Lenzner and Tomas Kellner , Forbes Magazine, 11.27.00

Kapitalism Kills, Kill Kapitalism
What's going on here?
Today, Monsanto; tomorrow, Merck.
Pharmaceutical: $121 b profit of $179 b sales
Monopoly protection
Threat To Profits
Real competition

Kapitalism Kills, Kill Kapitalism

THE NEW ENEMY OF THE FREE MARKET HAS A FACE A lot like Katika Kuhnreich's freckled and delicate, with red hair pulled back in a ponytail.

This 19-year-old student of martial arts from Cologne, Germany came to the Czech Republic recently one of perhaps 10,000 like-minded comrades to cause havoc in its beautiful capital, Prague. More specifically, to break up the latest meeting of the World Bank and International Monetary Fund. "The root of profit is in the exploitation of the working class," says Kuhnreich, her jacket sleeves rolled down to reveal her mantra in black block letters, Kapitalism Kills, Kill Kapitalism.

Half a world away, in Bombay, India, the biggest threat to capitalism isn't an anarchist. It's a 64-year-old entrepreneur named Yusuf Hamied, who is undermining the pharmaceutical industry by selling knockoffs of patented drugs for one-tenth the price or less.

There is palpable rage on the streets of Montpelier, Vt. Not from kids with dreadlocks and eyebrow ringsbut from retirees who are so fed up with the high cost of prescription drugs that they're boarding buses to Canada, where they can buy their medicines more cheaply. The same act of fiscal disobedience is repeated by elderly Arizonans, who spend three hours on buses to Mexico, where they can save hundreds of dollars on their monthly prescription bills.

What's going on here?

Anticapitalist demonstrations have always been a part of life in this country. But, until recently, they've been pretty much confined to college campuses, where such protests are a perennial rite of passage. These days, though, resentment against U.S. corporations, and the drug industry in particular, has boiled over into the American mainstream. The drug industry's prices are high, its profit margins are fat. Those profits are at risk.

We're not talking about fringe politicians or Naderites as the enemies of profits. We're talking about Republicans. Two hundred and ten of them voted for H.R. 4461 or its Senate counterpart, S. 2520. This is the bill that will, over the dead bodies of the pharmaceutical industry lobbyists, allow wholesalers to import drugs from abroad, so that American consumers can get the benefit of discounted prices charged elsewhere.

The bill was signed in early November by President Clinton. It will turn the pricing structure of the drug industry on its head. Right now pharmaceutical houses recoup their billion-dollar research outlays from U.S. customers, while letting customers elsewhere in the world pay a much smaller margin over manufacturing costs. It is extremely hard for a U.S. politician on either side of the aisle to explain this price discrimination as good for his constituents.

The importation bill, although somewhat limited in its scope, is probably just the opening wedge. It costs $100 a month in this country for a lifesaving dose of cancer-fighting tamoxifen, $1,200 a month for AIDS drugs, $329 for the world's most popular drug, Prilosec, which treats ulcers. Social Security pays an average $804 a month. The U.S. drug industry has made $26.5 billion in profit over the past 12 months. Add it up: The drug companies are inevitable prey for anticapitalist legislation.

Why now? At first the timing seems implausible. Employment is high, half the country owns stocks and capitalists are still savoring their triumph over communism. But if the past two decades have witnessed a surge in prosperity for corporations, they have also set the stage for the inevitable backlash. If profits are high, then we can afford to take corporations down a peg or two, is the implicit logic of the populist movement. It's timejust as it was nearly 100 years ago, when President Theodore Roosevelt went after the nation's biggest monopolies.

Think of what has happened in the past half-dozen years. Tobacco companies have gone from victory in the courtroom to a $246 billion settlement. Antitrust prosecutors on both sides of the Atlantic are treated as heroes. Oil drillers, perennial targets of protesters (see "Damned If You Do"), look like bad guys again, with their prices tripling in two years. The agricultural biotech industry went from smugness for its scientific accomplishments to a rout in the field of public opinion.

A few years ago biotech companies dismissed their enemies as Greenpeacers and Luddites. Not any more. Now there's a widely supported moratorium on new imports of genetically modified foods in Europe and a very similar sentiment running through the middle of America. Protesters certainly caught Monsanto flatfooted, lopping $8.6 billion off its market value, so weakening the company it was forced into a shotgun marriage with Pharmacia. The attack on Monsanto's seeds, coupled with the recent store-shelf panic over unapproved corn, probably set back crop biotechnology a decade.

Today, Monsanto; tomorrow, Merck.

"Your heydays are over, that's what I tell the drug companies," says Uwe Reinhardt, a medical economist at Princeton University. "I think their 18% rate of return on assets will be pushed to a more normal level. Just watch the slaughter."

Some of that slaughter, paradoxically, will be self-inflicted. Drug companies face an excruciating dilemma, where doing the right thing may result in doing themselves irremediable harm. Price discrimination makes economic sense for a product that has a huge fixed cost (namely, the R&D that found it) and a small marginal cost (the cost of pillmaking). You charge full price to a base of prosperous customers large enough to cover the R&D (40% of whose budgets are paid for by the National Institutes of Health, tax-payer funded), then get whatever you can from poorer customers.

It's also good public relations, if only for a while. If AIDS-fighting proteases cost $14,000 a year in the U.S. but something close to manufacturing costs $2,000 a year in Africa, that could be seen as a humanitarian gesture.

But at some point uninsured, unprosperous patients in the U.S. want to receive the humanitarian rate. Once you start making lifesaving drugs available at lower cost to the world's poorest peopleor to 65-year-olds in the have to explain why you cannot deliver the product at a uniformly low price to everyone. Here come price controls. There goes the R&D budget.

Pharmaceutical: $121 b profit of $179 b sales

The ten largest pharmaceutical companies in the U.S. have had collective sales of $179 billion over the past 12 months and collective gross profit (excess of sales over manufacturing costs) of $121 billion. It's that $121 billion in gross profit that is in play if the industry becomes subject to price controls, threatening marketing budgets, as well as R&D (a collective $20.5 billion) and pretax income ($40 billion).

The popular revolt against the pharmaceutical companies began with protesters. One was Act Up (AIDS Coalition to Unleash Power), a group that wants affordable treatment in the U.S. and to make AIDS drugs available at a fraction of that price to Africans. Next was Ralph Nader's Consumer Project on Technology, a five-year-old organization that has lobbied the NIH to release U.S. government-supported medical inventions to the World Health Organization so that they can be made available to the Third World.

Then came Medecins Sans Frontieres (Doctors Without Borders), a humanitarian organization that wants drugs widely available to the poor at little or no cost. MSF is not a radical organization. Its American chapter gets $17 million a year in funding from U.S. donors, and it won the 1999 Nobel Peace prize for helping out victims of human and natural catastrophes, as well as for documenting massacres in places like Rwanda and Bosnia. Why shouldn't it get cheap drugs if that's what it takes to save lives? "We have 2,000 volunteer doctors in the field," says Joelle Tanguy, executive director of MSF. "But they don't have sufficient supplies of the drugs required."


Big pharma can't move fast enough to defend itself in the court of public opinion. Bristol-Myers made a $100 million gift for clinics and research to help stop the spread of AIDS in southern Africa. Pfizer has offered to provide Diflucanwhich treats a deadly form of meningitis that often attacks AIDS victims and costs $10 a pill in the to South Africans for two years.

Selective discounting isn't a death blow to a pharmaceutical company. Glaxo Wellcome's Combivir, a patented AZT combination that lists at $8 a pill (a day's supply) in the U.S., is being offered for between 70 cents and 90 cents in the Third World. That open-end commitment is a "sustainable" price, says James Cochrane, Glaxo executive director, and shouldn't shave too much off the $1.5 billion a year the company gets from AIDS drugs.

But what happens when Americans aren't willing to pay $8? You get a drug reimportation bill, known as the Medicine Equity & Drug Safety Act of 2000.

The high cost of prescription drugs so dominated the election season that politicos from both sides were tripping over each other to appear more solicitous to the elderly. "I'm not waiting for the drug companies to come to the table before acting," says Republican Senator James Jeffords of Vermont, who pushed the bill through the Senate. And even House Majority Leader Dick Armey, once immovably opposed to undermining the drug industry's price structure, decided he couldn't hold back the populist tide and collected support for the bill.

Drug companies hate the reimportation bill which amounts to price controls. The pharmaceuticals argue, among other things, that consumers won't really save that much, given the costs of repackaging the pills from blister packs to vials and the extra U.S. health inspectors who will have to examine the imported medicines.

Threat To Profits

The real objection, of course, is the prodigious threat to profits. AstraZeneca, for example, pulled down $573 million last year from tamoxifen, the most widely prescribed breast cancer drug around, which has to be taken for up to five years. A three-month supply (180 pills) costs $298 in the U.S.but only $26 in Canada. Eli Lilly's antidepressant Prozac throws off $2.6 billion in annual sales, retailing at $115 for 45 capsules in the U.S., and $35 north of the 49th parallel.

How bad a hit to the drug business is anyone's guess at this stage. Constantine L. Clemente, Pfizer's executive vice president for corporate affairs, says that in the worst case, his company could lose 10% to 20% of its U.S. sales, projected at $14 billion next year. "These are uncharted waters," he says. "We could be hurt."

Monopoly protection

Expect another blow to the pharmaceutical industry early next year. In March Congress will hold hearings on whether to reduce the length of monopoly protection from 20 years to maybe 10.

Spearheading the effort in this country will be American consumer groupsand health maintenance organizations, which will insist (true or not) that prescription drugs are a major culprit in driving up health care costs. Financially battered HMOs will band together, says Princeton's Reinhardt, and insist on sharp discounts from listed retail prices.

Once again, how can lawmakers of any stripe resist the populist swell? "The drug industry sits in the hand of the government," says Reinhardt. "Ultimately, they will be pushed around by the government."

They may not have long to wait. Their patents are already endangeredby something called compulsory licensing. This allows a foreign government to take away an exclusive product when the health or safety of a nation is at risk. Under compulsory licensing, a generic manufacturer is allowed to produce a drug discovered by a U.S. pharmaceutical in exchange for a licensing fee. Those fees vary from deal to deal. Still, says Francis Palumbo, a pharmacy professor at the University of Maryland, they never compensate for the opportunity costs of being undersold by a generic. Compulsory licensing would have a "drastic impact," says Pfizer's Clemente. "It would make it impossible to develop lifesaving medicines from the human genome system."

Real competition

But it's already happeningj ust outside the boundary of patent laws. Indian entrepreneur Yusuf Hamied is trying to revolutionize the drug industry in the Third World. A Ph.D. chemist trained at Cambridge University, Hamied is the chief executive of Cipla, a publicly held, $220 million (sales) company that produces ingredients identical to blockbuster drugs developed by multinationalsbut sells them at 5% to 10% of their U.S. market prices.

Hamied is personally worth $550 million today because back in 1972 he convinced India's health minister, a family friend, to revoke the nation's patent laws. Now, he says, he is willing to supply AIDS drugs at a reasonable profit over his cost of production. Like providing d4T (a Bristol-Myers Squibb drug that reduces the viral load in HIV patients and sells for $4.50 a pill) to Nader's Consumer Project on Technology at 10 cents a tablet. Or offering a free year's supply of Nevirapine, Boehringer-Ingelheim's $8-a-pill drug that helps protect newborns from contracting the AIDS virus from their HIV-infected mothers, to the leading AIDS hospitals in Durban and Johannesburg, South Africa. (Boehringer is now offering to give the medicine away for a couple of years.)

"My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death," says Hamied, paraphrasing India's late prime minister Indira Gandhi. He is a big advocate of compulsory licensing.

Drug companies can take small comfort in the fact that Hamied might be out of business in five years. As a signatory to the World Trade Organization's Trade Related Aspects of Intellectual Property Rights agreement, India must by 2005 reinstate product patents.

But by then it may be too late. The noose around the drug companies from public interest groups, the elderly, politicians and HMOscan only draw tighter. One WTO executive puts the issue in blunt but believable terms: "Either the prices give or the patent system will have to give."

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Date: 21 Nov 2000 10:31:40 U
From: joe

"The United States Environmental Protection Agency may have erred in assuming that toxicity may not be expected from consumption of genetic material in genetically modified crops"

EPA may be wrong judging toxicity of GE food

Prof. Joe Cummins, 6 November 2000

The regulation of genetically modified (GM) crops in the United States and Canada allows approval of GM crops for consumption by farm animals but not humans. The category usually is an interim step in the approval of GM crops for consumption by humans. The procedure has proved faulty because the processed products of GM crops approved for animal consumption but not humans has been found contaminating foods destined for human consumption.

Aventis Crop Sciences patented StarLink corn containing the Cry 9C insect tolerance gene from Bacillus thurningiensis subsp. Tolworthi was approved for use in animal feed but not human food but found contaminating many products sold for human consumption. On October 24,2000 Aventis submitted an updated safety assessment to support their petition to exempt the requirement for tolerance for all raw agricultural commodities , thus allowing use in products destined for human consumption.

The Aventis petition was supported, in part, by a comment from a 1998 United States environmental Protection Agency (EPA) review of StarLink (EPA 1998). That comment "DNA is common to all forms of plant and animal life and the Agency knows of no instance where these nucleic acids have been associated with toxic effects related to their consumption as a component of food. These ubiquitous nucleic acids as they appear in the subject plant-pesticide have been adequately characterized by the applicant and supports EPA's conclusion that no mammalian toxicity is anticipated from dietary exposure to the genetic material necessary for the production of the Cry9C protein."

The EPA comment seems to have failed to take into account a wealth of recent scientific findings on the effect of bacterial DNA on the immune system and the transforming ability of dietary, inhaled and dermal applications of DNA. The following discussion will focus on the data showing that the genetic material in GM crops may significantly effect those consuming the crop that was ignored or disregarded in the EPA review and Aventis assessment.

It is worth pointing out that the EPA opinion failed to acknowledge that fragments of ingested DNA from the M13 bacteria phage has been found incorporated into the DNA of the chromosomes in somatic tissues of the mouse (Schubbert et al 1997) and DNA of corn was found incorporated into the cells in meat of hogs fed corn (Jahreis and Kraft 2000). The significance of such gene incorporations has not yet been established. It may or many not be associated with detrimental consequences. Nevertheless, it is not prudent to ignore such important observations. Indeed, a moratorium on spread of GM crops is warreneted and should be placed until the impact of the new findings is evaluated.

Naked and free nucleic acid has been has been identified as significant unregulated hazards (Ho et al 1999). DNA vaccines have generated a huge literature and clinical applications showing the activity and cellular incorporation of DNA administered by oral, inhalation, injection,vaginal or dermal application (Molling 1997,Donnoley et al 1997 and Gurunathan et al 2000). Ingestion of bacteria does not appear to be an effective means of delivering DNA because the bacterial cell walls effectively contain the nucleic acid (for example, in yogurt the milk products are digested but the bacteria of the culture are passed intact).

Lysis genes have been found necessary and effective in triggering release of DNA for mucosal vaccine delivery (Jani and Mekalanos 200). In contrast , the crops eaten by animals release oligonucleotides and DNA peptide complexes during digestion and such molecules circulate to a significant degree.

The bacterial genes used in constructing GM crops have a property that impacts on the immune system over and above the ability to produce antibodies. Eukaryote DNA has relatively low frequencies of the dinuleotide motif CpG and that motif is methylated and plays a role in gene regulation while bacteria and their viruses have a high frequency of the CpG motif that is usually unmethylated. Apparently the CpG motif in DNA molecules and oligonucleotides provides a signal that the immune system recognizes and initiates a primary sequence of reactions leading to activation of the immune system leading to inflammation (Manders and Thomas 2000 and Gurunathan et al 2000).

Oligonucleotides rich in the CpG motif are used to enhance immunization. Inflammation is an essential part of the immune response but it adversely effects existing conditions such as autoimmune disease. Furthermore, it has been found that CpG oligonucleotides rescue B cell lymphoma cells from anti-IgM mediated growth inhibition (Han et al 1999). The oligonucleotide acts as a promoter of lymphoma.

Finally, Gorecki and Simons (1999) pointed out a danger to the fetus in DNA vaccination of the mother. That danger was the creation of tolerance in the fetus leading to individuals more susceptible to infection and/or they may become carriers. The introduction of genes with bacterial CpG motif to the fetus is likely to have untoward consequences.

In conclusion, the bacterial genes used in GM crops have been found to have significant impacts on the individuals ingesting GM crops. The impacts include inflammation and lymphoma promotion. The consequence of GM food genes being incorporated into the chromosomes of somatic cells of those consuming GM food and their unborn has been ignored by those charged with evaluating the hazards of GM crops. EPA erred in ignoring such important findings in evaluating StarLink corn.


  1. Aventis " Updated Safety Assessment of StarLink TM Corn Containing Cry 9C Protein" October 24,2000 Aventis Crop Science 74 pp
  2. Donnelly,J,Ulmer,U,Shiver,J and Lui,M. "DNA Vaccines"1997 Annu Rev Immunol 15,617-48
  3. Gorecki,D and Simons,J "The dangers of DNA vaccination" 1999 Nature Medicine 5,126
  4. Guunathan,S,Klinman,D and Seder,R. "DNA Vaccines" 2000 Annu Rev. Immunol 18,927-74
  5. Hsu,S,Chung,S,Robertson,D,Ralph,L,Chelvarajan,R and Bondada,S 1999 "CpG oligodeoxynucleotides rescue BKS-2 immature B cell lymphoma from anti-Ig-M-mediated growth inhibition by up-regulating of egr-1" International Immunology 6,871-9
  6. Ho,M,Ryan,A,Cummins,J andTraavik,T 'Unregulated hazards "naked" and "free" nucleic acids" 1999 ISIS Report Prepared for the Third world Network
  7. Jahreis,G and Kraft,J "Fate of forage DNA in farm animals" 2000 European Food Research and Technology 212
  8. Jain,V and Mekalanos,J "Use of lambda phage S and R gene products in an inducible lysis system from Vibrio cholerae and Salmonella enterica servovar Typhimurium-Based vaccine delivery systems" 2000 Infection and Immunity 68,986-9
  9. Manders,P and Thomas,R "Immunology of DNA vaccines: CpG motifs and antigen presentation" Inflamm Res 49,199-205
  10. Molling,K "Naked DNA for vaccine or therapy" 1997 JMolMed 75,242-6
  11. Schubbert,R,Renz,D,Schmitz,B and Doerfler,W "Foreign (M13) DNA ingested by mice reaches peripheral leucocytes, spleen,and liver via the intestinal wall mucosa and can be covalently linked to mouse DNA" 1997 Proc. Natnl Acad Sci USA 94,961-6
  12. United States Environmental Protection Agency "Bacillus Thuringiensis Subspecies tolworthi Cry9C Protein and the Genetic Material Necessary for its Production in Corn; Exemption from the Requirement of a Tolerance"Federal Register May 22,1998 (volume 63,number 99) Rules and Regulations

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Date: 21 Nov 2000 12:24:58 U

URL: Insanex managed to provoke EuropaBio to the extend of legal threats

You are kindly invited to visit

They managed to provoke EuropaBio to the extend of legal threats.

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Date: 21 Nov 2000 13:07:06 U
From: joe

Xenotransplantation: New company for humanized pigs

Several of the main players in the area of humanized pig production for transplantation replacement parts have dropped out because of the dangers of pig endogenous retrovirus (PERV) release following transplantation to humans.PERVs are retorviruses with HIV like properties.

According to Genetic Engineering News 15 6 Novartis Pharma (Basel) owner of Imutran (UK) the originator of humanized pigs and Biotransplant(USA) has formed a separate company to handle xenotransplantation. The company will be located in Boston starting Jan 2001 and be headed by Julia Greeenstein who will be the chief pig person. Dwarf pigs will be replacing the standard humanized hogs because their organs fit people better and are believed to be freer from PERV release.

Ongoing programs such as the Novartis Canadian program at Guelph, University of Western Ontario and University of Toronto are currently up in the air, facing an uncertain future.The Canadian Food Inspection Agency are believed to be considering a "mild proposal" that surplus Canadian babies be marketed as replacement parts for rich americans to avoid the PERV problem.

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Date: 21 Nov 2000 16:57:42 U

CONTACT: Ariane Kissam, 202-543-5675 or Mark Smith, 617-354-2922, both of the Farmer to Farmer Campaign on Genetic Engineering

US: Legal issues of biotech questioned

Selected by Pro Farmer Editors, PR Newswire, November 21, 2000

WASHINGTON – Family farm groups participating in the Farmer-to-Farmer Campaign on Genetic Engineering are calling on their state Attorneys General, who are on the front line of the GE debate, to fill a policy vacuum caused by national inaction. Farmers point to StarLink as a prime example of how our current regulatory segregation and marketing systems are not able to deal with the complex issues that genetic engineering pose.

"While USDA has aggressively promoted biotechnology in agriculture, they have done virtually nothing to address farmer liability issues or to ensure that farmers are adequately protected under current industry contracts" said Bill Christison, a Missouri farmer and president of the National Family Farm Coalition. "Farmers are rapidly losing valuable export markets because of the challenges imposed on farmers by the entire biotech industry." Speaking for the Farmer to Farmer Campaign, Christison said Attorneys General need to move beyond responding to crises such as the Starlink debacle and initiate long- term actions to create farmer protection for liability.

Participating grassroots organizations in eight key farm states are calling on their Attorneys General to promote possible legislation to place liability on companies that develop and patent genetically engineered seeds. Farmers will also ask the Attorneys General to investigate the marketing of genetically engineered seeds and the rapid corporate concentration of seed companies and suppliers.

"The full extent of farmers' legal liability resulting from growing and marketing GMO crops is unclear. What is clear is that farmers may face substantial liability for violations of GMO contracts, contamination of neighbors' crops, or infringement of the companies' patents," said Lynn Hayes, an attorney with the Farmers Legal Action Group. "Before planting GMO crops farmers should fully understand their responsibilities and evaluate the risks of potential liability."

Organizations working in collaboration on the Farmer-to-Farmer Campaign are asking state Attorneys General to:

Farm groups participating in this multi-state strategy are members of the Farmer-to-Farmer Campaign on Genetic Engineering in Agriculture, a collaborative effort among family farm organizations to promote the farmer perspective on genetic engineering. Today marks the one-year anniversary of the release of the Farmer's Declaration on Genetic Engineering in Agriculture. For the past year, farm groups have been expanding the farmer voice on genetic engineering.

CONTACT: Ariane Kissam, 202-543-5675 or Mark Smith, 617-354-2922, both of the Farmer to Farmer Campaign on Genetic Engineering

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Date: 22 Nov 2000 06:32:11 U

Last year Credit Suisse warned biotech companies they were headed for failure (see article 1). Since then ag-biotech's downward spiral has continued and more and more financial analysts are predicting it's downfall (see article 2).

This is hardly surprising since genetic engineering is fundamentally flawed. It involves making irreversible changes in a random manner to a complex level of life about which little is known. Independent geneticists have warned that this hit-or-miss approach must disrupt the natural intelligence of the plant or animal to which it is applied, leading to health-damaging side-effects and irreversible environmental problems (see enclosed quote).

Time is indeed running out for the biotech industry and there is nothing they can do to reverse this trend. As one observer put it: "sell your ag-biotech shares while you still can" (...and don't put them into GE pharmaceuticals as they are bound to fail in time also).

Ron Baxter

Credit Suisse warnes: Time is running out for the biotech industry

People Power Blow to GM Food

By John Ingham And Lucy Johnston , From the front page of The Express, 24/12/1999

THE biotech revolution is in danger of failure in the face of consumer power, one of the world's top investment banks has warned.

In a new body blow to the beleaguered industry, Credit Suisse First Boston says the commercial development of genetically modified organisms is suffering from "negative momentum". It says food manufacturers are running scared of GM crops, and that key questions about the technology may not be answered for several years.

Analysts warn in a series of briefings that the issue is out of control for big business and government. "If anyone is in control it appears to be environment and consumer groups."

The Express has been leading the campaign for public choice over GM foods and tighter controls on GM crops since summer 1998.

We have called for all food to be clearly labelled and for delays on commercial planting until independent research has proved they are safe for the environment.

Credit Suisse compares GM technology with nuclear power. It says both are scientifically sound but warns: "No one is building new nuclear plants today."

After surveying consumer reaction, it says: "The march of progress with GM crops no longer appears inevitable to us."

The bank's analysis will cause fresh alarm among investors who have already seen the share values of some biotech firms fall.

In the past year shoppers in Britain and Europe have overwhelmingly rejected GM food. Even US consumers are now beginning to rebel amid fears about the long-term consequences.

The reports are all the more damaging because Credit Suisse's clients have included some of the world's top biotech firms. They follow similar warnings by the influential Deutsche Bank earlier this year.

Friends of the Earth claimed last night that the City was turning its back on biotech firms.

Spokesman Adrian Bebb said: "Time is running out for the biotech industry. "One of the world's biggest financial advisers appears to have little faith in it."

The newly announced merger between biotech giant Monsanto and a Swedish firm is seen as further evidence that the GM revolution is running out of steam. In the past 14 months Monsanto shares have nearly halved in value.

Novartis, as predicting that it will take up to five years for Europe to accept the crops.

© Express Newspapers, 1999

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Date: 22 Nov 2000 08:28:12 U
From: joe

The article below gives new information on resistance to Bt.

resistance to Bt in bollworm

Proc. Natl. Acad. Sci. USA, Vol. 97, Issue 24, 12980-12984, November 21, 2000

Frequency of resistance to Bacillus thuringiensis in field populations of pink bollworm

Bruce E. Tabashnik*, [dagger ] , Amanda L. Patin*, Timothy J. Dennehy*, Yong-Biao Liu*, Yves Carriere*, Maria A. Sims*, and Larry Antilla [Dagger ]

* Department of Entomology, University of Arizona, Tucson, AZ 85721; and [Dagger ] Arizona Cotton Research and Protection Council, Phoenix, AZ 85040

Communicated by William S. Bowers, University of Arizona, Tucson, AZ, September 19, 2000 (received for review April 14, 2000)


Strategies for delaying pest resistance to genetically modified crops that produce Bacillus thuringiensis (Bt) toxins are based primarily on theoretical models. One key assumption of such models is that genes conferring resistance are rare. Previous estimates for lepidopteran pests targeted by Bt crops seem to meet this assumption.

We report here that the estimated frequency of a recessive allele conferring resistance to Bt toxin Cry1Ac was 0.16 (95% confidence interval = 0.05-0.26) in strains of pink bollworm (Pectinophora gossypiella) derived from 10 Arizona cotton fields during 1997. Unexpectedly, the estimated resistance allele frequency did not increase from 1997 to 1999 and Bt cotton remained extremely effective against pink bollworm. These results demonstrate that the assumptions and predictions of resistance management models must be reexamined.

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Date: 22 Nov 2000 16:48:06 U
From: joe

An interesting take on industry interference. [nature] 23 November 2000

Biotech report dubbed 'worthless'

By Haim Watzman, Nature 408, 394 (2000) © Macmillan Publishers Ltd.

[JERUSALEM] Research directors at Israel's universities say that an upcoming government-sponsored report on biotechnology policy will be worthless because they were not consulted by its authors.

"The authors of the report are completely unaware of the reorganization the universities have undergone to take into account the needs of high-tech," says Yair Aharonowitz, vice-president and dean for research at Tel Aviv University.

Aharonowitz and colleagues at five other universities sent a letter of protest to Carmel Vernia, chief scientist at the Ministry of Industry and Trade. Earlier this year Vernia commissioned a report on the state of Israel's biotechnology industry from the Monitor Group, a consulting firm. Although Monitor has until the end of the year to submit its report, the Israeli press has reported that it will call for the diversion of money from basic research to work with clearer commercial potential.

Any such diversion would be a "gross error", Menachem Magidor, president of the Hebrew University of Jerusalem, declared in a recent interview. Aharonowitz says that Monitor got all its information from industry, and made no contact with five of the six Israeli universities with life-science faculties.

Vernia declined to comment, but a spokesman said that he had "recommended that Monitor meet with the research vice-presidents towards the conclusion of the process of writing its report".

[Macmillan Magazines] Nature © Macmillan Publishers Ltd 2000 Registered No. 785998 England.

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Date: 23 Nov 2000 17:26:14 U
From: Robert Mann

NZ: Comstock and The Life(r) SciencesA PRgang

The seminar at St John's College 00-11-23 by Prof Gary Comstock, Iowa State U, was an example of how such things should not be done.

The Life(r) SciencesA PRgang had brought this Baptist ethics teacher to talk to the Royal Commission on GM, because after a decade of concern about GM he has lately said it's OK. Then somehow they got Rev Graham Redding, minister of Somervell Presbyterian church, Remuera, to organise this seminar at the Anglican/Methodist theological college.

Graham seemed to be in the position of chairman but did not try to control interjections until they had got well out of hand. I felt embarrassed that the speaker was, time after time, heckled down in mid-sentence, and I apologised to Comstock for his being so rudely treated.

To make matters worse, the hecklers were mostly of a wimpish style, trying to imply by very quiet voices that they were unassertive. Thus, they disrupted the seminar but also failed to communicate to many of the 2 doz others present what they had to say.

After many such interruptions, Graham did intervene to say the speaker should be allowed to finish – about 10 min – and then questions would be allowed, with preference for those who had not yet spoken.

Only after about 75 min altogether did I get a chance to speak; and Graham defined this as the last contribution. As we were so far over time I had to be very brief; thus ill-considered emotive heckling had taken up considerable time, but careful objections were cramped in time.

Comstock was appalling.

He insists on misusing words: he renames 'intrinsic' and 'extrinsic' the two categories of argument which are normally called ecological and ethical. I see no good reason for this word-tampering.

On the level of fact, he was usually astray. He stated 'golden rice' has only one gene inserted, and presented as a fact its possible prevention of blindness in large numbers of Third World children. Is it possible that he does not know of, for instance, Ho's refutations ? He made numerous mis-statements of fact.

Worse, he relies almost entirely on straw-man knock-downs. Nearly all the arguments which he presents are ignorant caricatures – real, in the sense that there are some who assert them, such as the political activists who were heckling him today, but no serious scientist or ethicist does actually advance them, so they shouldn't be raised in a tertiary institution.

Comstock didn't mention the main arguments in written criticisms of GM. I fail to imagine that he is unaware of the serious arguments from ecological viewpoints.

On the ethical & theological arguments he relied heavily on the vagueness of concepts such as 'playing God', in a biased way. He wasted time rebutting the practically non-existent idea 'we shouldn't tamper with nature', as if there is some significant school of thought against ALL technology. He didn't get around to discussing any of the main arguments. In his many-page handout he gave no refs to respectable critics e.g. or

When I briefly challenged him for these biases, he refused to respond.

What a creep!

If this is the best the Life (r) SciencesA PRgang can put up, we've got it made. But we will do better if we refrain from heckling in academic seminars. And when heckling is performed, let's not put on the phoney meek act as well – at least make the interjections audible!


Robt Mann
Mulgoon Professor emeritus of Environmental Studies, U of Auckland consultant stirrer & motorcyclist
P O Box 28878, Remuera, Auckland 1005, New Zealand (9) 524 2949

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Date: 24 Nov 2000 12:46:39 U

European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6 , D – 38116 Braunschweig , Germany

phone: +49-531-5168746     fax: +49-531-5168747


Date: 25 Nov 2000 00:31:52 U
From: Robert Mann

Comment on the article below by Prof. R. Mann

Just in case anyone hasn't noticed, this stunt of media promotion before the scientific journal has published the detailed results has been widely condemned in the world of science. Indeed, one of the claimed reasons for vilifying Dr Pusztai was that the results he summarised on TV had not been published. Note the double standard: it's OK for the gene-jockeys to make claims of benefits thru the media, but any allegations of drawbacks in GE are not to be given out thru the media.

The difference of course is that the hazards Pusztai stumbled upon implied possible serious harm and therefore were much more urgent for publicity than any 7 or 8% improvement in productivity. It is much more ethically dubious to 'jump the gun' by mass-media announcement of a mere commercial improvement than to alert people to a possible harm without waiting a year or two for processing by a scientific journal.


Robt Mann, consultant ecologist, P O Box 28878 Remuera, Auckland 1005, New Zealand, (9) 524 2949

Sheep growth accelerated by GE lupins

CSIRO Media Release, Australia, November 22, 2000, Ref 2000/310

Increased wool growth and live weight gain in Merino sheep are the results of a recent CSIRO feeding trial using genetically modified lupins. The trial explored nutritional benefits of lupin seeds genetically modified to incorporate a sunflower gene that stimulates the production of a highly nutritious protein. CSIRO Livestock Industries' Dr Colin White says the feeding trial resulted in an eight per cent increase in wool growth and a seven per cent increase in live weight gain in the sheep fed the modified lupins. All sheep in the trial maintained good health and are doing well.

"The results have the potential to be converted into an additional 160 tonnes of wool per year. In other words farmers could produce more wool from the same number of sheep, or alternatively they could produce the same amount of meat or wool with fewer sheep and lower cost," says Dr White. The GMAC-approved trial was conducted over six weeks with 80 sheep that were divided equally into two groups and fed a cereal-hay based diet containing either modified or unmodified lupin seed. CSIRO Plant Industry scientist, Dr TJ Higgins, says this research potentially offers a valuable boost to Australian wool by reducing costs, increasing profits and making production more efficient.

The lupin is the major legume grain used on-farm as supplementary feed for sheep during the summer drought, with approximately 200,000 tonnes of the 1.2 million tonnes produced annually in South-western Australia used for this purpose. "Wool and muscle growth has a high demand for sulphur amino acids, which are absorbed through the sheep's small intestine," says Dr Higgins, "but the sheep's first stomach, the rumen, tends to break down up to 40% of these essential nutrients before they reach the intestine."

"We have modified the lupin to contain a sunflower gene that produces a protein that is both rich in sulfur amino acids and stable in the sheep's rumen. This protein acts as an efficient package for delivering the extra sulfur amino acids where they are needed to achieve better growth. We are pleased with the results which are a culmination of over ten years of research, including a stringent environmental safety assessment process." With successful results from the lupin trials, the researchers are currently working towards similar positive results with subterranean clover, an important pasture plant for the wool industry.

All CSIRO gene technology research is carried out according to the strict guidelines of the Federal Government's Genetic Manipulation Advisory Committee (GMAC). The research is supported by grain-growers and the Federal Government through the Grains Research and Development Corporation (GRDC) and by the Centre for Legumes in Mediterranean Agriculture (CLIMA).

The findings will appear in the international Journal of Science of Food and Agriculture.

More information from:

  • Dr TJ Higgins, CSIRO Plant Industry, 02-6246 5063
  • Dr Colin White, CSIRO Livestock Industries, 08-9333 669
  • Rachael Mitchell, CSIRO Plant Industry, 02-6246 5323, mobile 0417 240 261,
  • Jane Kahler, CSIRO Plant Industry, 02-6246 5077, mobile 0419 494 137,

    Ms Jane Kahler
    Communication Manager, CSIRO Plant Industry, GPO Box 1600, Canberra ACT 2601
    Phone: +61 2 6246 5077    Fax: +61 2 6246 5299    Mobile: +61 0418 626 860

    Mr Nick Goldie, Journalist
    CSIRO National Awareness, PO Box 225, Dickson ACT 2602
    Phone: +61 2 6276 6478    Fax: +61 2 6276 6821    Mobile: +61 0417 299 586

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    Date: 24 Nov 2000 16:30:17 U
    From: joe

    The study below shows that cloned animals retain epigentic features characteristic of the animal from which they originated. Many such features are intangible and for that reason such animals must be more fully studied before being released generally.

    cloned animals need fuller study

    Science Nov 24 2000: 1578-1581.

    X-Chromosome Inactivation in Cloned Mouse Embryos

    Kevin Eggan,12* Hidenori Akutsu,3* Konrad Hochedlinger,1 William Rideout III,1 Ryuzo Yanagimachi,3 Rudolf Jaenisch12 [dagger ]


    To study whether cloning resets the epigenetic differences between the two X chromosomes of a somatic female nucleus, we monitored X inactivation in cloned mouse embryos. Both X chromosomes were active during cleavage of cloned embryos, followed by random X inactivation in the embryo proper. In the trophectoderm (TE), X inactivation was nonrandom with the inactivated X of the somatic donor being chosen for inactivation. When female embryonic stem cells with two active X chromosomes were used as donors, random X inactivation was seen in the TE and embryo.

    These results demonstrate that epigenetic marks can be removed and reestablished on either X chromosome during cloning. Our results also suggest that the epigenetic marks imposed on the X chromosomes during gametogenesis, responsible for normal imprinted X inactivation in the TE, are functionally equivalent to the marks imposed on the chromosomes during somatic X inactivation.