Genetically
 Manipulated 


 

 
 
 Food


 News

3 January 2000

Table of Contents

Sick of GMOs? Speak Truth to Shareholders
New Book about GE from Dr. Martin Teitel
Despite Protestes, A Few Newbies Try To Invent Next Generation Plants
Transgenic and Mad Cow Disease
GE Future Products: Science Invades Pantry
Prince Charles' Millenium address on GM and Nature
Commercialization of Genetic Research and Public Policy
Gene Researchers Face Crisis As Man's Saviour Turns Killer
Gene Therapy: Death Raises Question of Ethics, Profit, Science
Jellyfish Gene in Monkey Embryo
Percy Schmeiser: Seeds of Doubt
Crops patented worldwide

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Date: 31 Dec 1999 21:27:51 U
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: Margaret_Weston@capmac.org (Margaret Weston)
From: "Graham Caswell" caswell@indigo.ie
Newsgroups: misc.activism.progressive

Sick of GMOs? Speak Truth to Shareholders

Sick of GMOs?

"Speak Truth to Power"

Tell the shareholders and executives of GMO corporations exactly what you think and feel. You can do this on the following message boards....

Monsanto http://messages.yahoo.com/?action=Q&board=MTC

DuPont http://messages.yahoo.com/?action=Q&board=DPMI

AstraZeneca http://messages.yahoo.com/?action=Q&board=AZN

American Home Products Corp. http://messages.yahoo.com/?action=Q&board=AHP

Aventis http://messages.yahoo.com/?action=Q&board=AVE

You do have to register, but it's easy and its customary to stay anonymous.

Go on........ Express yourself! (it'll make a difference)

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Date: 31 Dec 1999 21:35:42 U
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: Margaret_Weston@capmac.org (Margaret Weston)

New Book about GE from Dr. Martin Teitel

Martin Teitel, PhD will tell us why our food has been genetically altered – without our consent – and with no testing and no labeling – and what we can do about it.

Book:

Genetically Engineered Food: Changing the Nature of Nature: What You Need to Know to Protect Yourself, Your Family, and Our Planet

Info about the book at: http://www.amazon.com/exec/obidos/asin/0892818883/artbell00/104-0677997-6278830

Editorial Reviews

  1. Ralph Nader
    As bioengineered crops cover ever more millions of acres, the likelihood of side effects and unintended consequences looms larger. Farmers will realize they were not told enough of the truth. And consumers will see there is no escape other than to fight back and demand an open scientific process and a response to persistent questions, with the burden of proof right on the companies. All this and more is why Genetically Engineered Food: Changing the Nature of Nature is so valuable for enlightening the public.

  2. Jeremy Rifkin, author of The Biotech Century
    Martin Teitel and Kimberly Wilson have cut through all the hype and misconceptions surrounding genetically engineered food and provided the indispensable primer for every family in America concerned with making wise dietary choices in the biotech century. Finally, we have available a guide to biotech food issues that is informed, intelligent, and chock-full of common sense. I urge every consumer to read this book before walking into a supermarket again. It will open up your eyes, change what you put in your mouth, and transform your thinking about food forever.

  3. Katherine DiMatteo, Executive Director, Organic Trade Association
    By far the most accessible and informative publication on genetic engineering in food production that I have read to date. It is written so that the non-scientist can fully understand the scope of this technology, with numerous footnotes and references that are a handy resource guide for those seeking more knowledge. An excellent book.

Book Description

The book that exposes the threat to our food supply from genetic engineering.

Picture a world where the french fries you eat are registered as a pesticide. Where corn plants kill monarch butterflies. Where soy plants thrive on doses of herbicide that would kill any normal plant. Where multinational corporations own the life forms that farmers grow and legally control the farmers' actions. That world exists.

The above events are happening, and they are happening to us all. Genetically engineered foods – plants whose genetic structures are altered by scientists in ways that could never occur in nature – are already present in most of the products you buy in supermarkets, unlabeled, unwanted, and largely untested. The threat of these organisms to human and environmental health has caused them to be virtually banned in Europe, yet the U.S. government and a handful of biotech corporations, working hand-in-hand, have actively encouraged their use while discouraging labeling that might alert consumers to what they are eating. Genetically Engineered Food: Changing the Nature of Nature is the first book to take a comprehensive look at the many ramifications of this dangerous science.

Authors Martin Teitel and Kimberly Wilson explain what genetic engineering is and how it works, then explore the health risks involved with eating newly created lifeforms. They address the ecological catastrophe that could result from these modified plants crossing with wild species and escaping human control altogether, as well as the economic devastation that may befall small farmers who find themselves at the mercy of megacorporations for their livelihood. Taking the discussion a step further, they consider the ethical and spiritual implications of this radical change in our relationship to the natural world, showing what the future holds and giving you the information you need to act on your own or to join others in preserving the independence and integrity of our food supply.

About the Authors

Martin Teitel, Ph.D., is the author of Rain Forest in Your Kitchen and Executive Director of the Council for Responsible Genetics, a national nonprofit organization of concerned scientists, doctors, and activists founded in 1983 to foster public debate about the social, ethical, and environmental implications of genetic technology. Kimberly Wilson directs the council's Program on Commercial Biotechnology and the Environment.

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Date: 1 Jan 2000 13:36:21 U
From: MichaelP papadop@peak.org

Despite Protestes, A Few Newbies Try To Invent Next Generation Plants

By PAUL JACOBS, LA Times Staff Writer, December 31.

A Few Rush to Exploit New Biotech Crops Genetics: Young firms such as Ceres see this as a golden age. Despite protests, they are inventing the next generation of plants.

Worldwide protests against genetically engineered crops are on the rise. America's trading partners are calling for labeling of foods that contain ingredients from genetically modified plants. Federal regulators are reexamining the rules for assuring the safety of biotech foods.

Against this tumultuous backdrop, a handful of young companies are busily inventing the next generation of biotech plants – crops that promise increased food production and improved nutritional content, or that offer a renewable, low-cost supply of medications and industrial chemicals.

These small firms see this as a golden age of plant biology, and they are betting that the controversies will cool and the world will warm to their innovative products.

One of the newest and most promising of these emerging companies is Ceres Inc., started in 1997 by a UCLA professor and his corporate partners with more than $50 million in private capital. After leasing unused lab space on the university campus, the company now sits in what at first blush seems the most unlikely of places for an agricultural research facility – high on a hill above Malibu Canyon, with a glorious view of the Pacific.

Like its competitors, which include the large seed producers as well as smaller firms, the company is rushing to exploit new developments in plant biology. The advances include the rapid decoding of genes, high-speed methods for isolating gene products and discovering their function, and efficient ways to transplant desirable genes from one species into another.

The search for genes is called genomics, and says UCLA biologist Robert B. Goldberg, a co-founder of Ceres, the company is "trying to position itself to be the premiere plant genomics company in the world and compete with DuPont and Monsanto and Novartis."

Goldberg says that unearthing just a few important genes – he calls them "undiscovered diamonds" – from the tens of thousands present in a few species of plants will be enough to put the company over the top. "We're looking for breakthrough traits," he said.

And the company may already have some of them, licensed from UCLA and other University of California campuses. These are genes that can boost grain tonnage by increasing the size of seeds, by growing seeds not just from flowers but in leaves, and by producing seeds without pollination.

Cranking up food production will be increasingly important to feed a growing world population – more important in many parts of the world than advances in genetic engineering that lead to new medications, says Richard Flavell, Ceres' chief scientific officer.

"In that part of the world where 3 billion people suffer from nutritional deficiency, your first thought is not how to get [medicine] to people, but how do I feed them," Flavell said.

The hiring of Flavell was a coup for the fledgling company. He's the former director of the John Innes Centre in England, a world leader in plant genetics. Last year, he was elected to Britain's Royal Society – a body that includes numerous Nobel laureates and that was once headed by Sir Isaac Newton.

"To kick-start the firm," Flavell said, the company has farmed out its gene sequencing – the decoding of the chemical building blocks of plant DNA – to Genset, a French company that has one of the world's largest factories for deciphering plant, animal and microbial genes.

And it is working closely with university scientists at University of California campuses in Los Angeles, Santa Cruz, Berkeley and Davis.

"The business strategy is to get immediate access to mature programs," he said, by licensing technology already developed and working with established researchers.

Ceres recently broke ground on its first greenhouse. "Most of our plants are in enclosed cabinets," Flavell said. "But we're moving to a bigger scale, we're ramping up. In a couple of years we'll be into crop plants."

The company is planning to work with the large seed companies to distribute its products. "If we want to penetrate large markets, as a small company, we can't do that efficiently by ourselves," he said.

But eventually, Ceres could develop its own line of seeds. "We want to be a product company, and not just a technical supplier," Flavell said.

Goldberg helped found the company after a successful collaboration with Plant Genetic Systems in Belgium that led to a new method for creating plant hybrids that is widely used in the seed industry.

That work, Goldberg said, convinced him of the power of collaboration in producing improved plant varieties, and he set out to establish a nonprofit institute that would bring together academic scientists from several campuses.

But he had difficulty finding the money he needed, even with the argument that the new technology could help feed the world. "I went to Hollywood people," he recalled in a recent interview. "They could see cancer, but they couldn't see hunger."

He turned instead to the head of Plant Genetic Systems, Walter De Logi, a Caltech-educated astrophysicist who in 1996 had just sold his company to international seed giant AgrEvo for $750 million.

Goldberg recalls the conversation this way: "I said, 'Do you want to start an institute?' He [De Logi] looked at me and he said, 'Do you want to start a company?' "

They finally agreed to do both. De Logi and venture capitalist Edmund "Ned" M. Olivier of Oxford Bioscience Partners raised the money to start Ceres and fund the Seed Institute at the four UC campuses and the University of Utah. In exchange for providing $5.75 million over five years to underwrite university researchers, Ceres gets first crack at the rights to their inventions. An independent university committee oversees the collaboration to protect the university from potential conflicts of interest.

De Logi is Ceres' CEO; Olivier chairs the company's board of directors; Goldberg sits on the board.

Company executives say they have no immediate plans for a public stock offering. They say they have enough capital to last couple more years, and may get additional rounds of private financing before contemplating a stock offering.

Ceres quickly outgrew its leased university lab and moved to the Hughes Research Laboratories in Malibu, which had space available after downsizing – an illustration of how new technologies can fill the gaps in a local economy left by shrinking, older industries, in this case aerospace. It now has 80 employees, most of them scientists.

And it is not alone in seeing an opportunity to harness the power of plant genomics to create crops with improved traits, including increased production levels. In fact, there seems to be the genetic equivalent of a gold rush going on, with a number of companies racing to stake their claims on useful plant genes.

Insiders say that the research is revving up despite the controversies swirling around genetically modified foods.

"I think contrary to what the public perception is about the state of genetically modified organisms and the state of biotechnology, behind the scenes it is going farther and faster than ever before," said Dean V. Cavey of Verdant Partners, an investment banking and consulting group that specializes in crop genetics.

In fact, investors in Ceres and other companies are hoping that by the time a new generation of genetically modified crops is ready, three to five years from now, the public will be satisfied that the crops present no hazards to consumers or to the environment.

"There's no question that the protests are putting a damper on the field at the moment," said Michael Fromm. president of Mendel Biotechnology in Hayward. But improvements in the speed and scale of gene discovery "reached a fever pitch in the genomics of the 1990s," he said, and promise marked improvements in food production and quality.

"The opportunities are immense," said Richard Kouri, chief business officer at Paradigm Genetics in Research Triangle Park, North Carolina. The early work in plant genetics was mostly to help farmers, Kouri said. "Now we're shifting more to output traits, health related, industrial related, and food related."

Paradigm, Mendel and Ceres are among the newer companies that have joined the race to discover genes for traits that can be transferred to crops.

There's room for many more of these companies, says Verdant Partners' Ken Moonie, but the anti-biotech protests have made it difficult for additional start-ups to enter the field.

And that's good news for companies like Ceres and the others that have already secured the initial capital they need.

"Timing in this world is everything," Moonie said.

*** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. ***


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Date: 1 Jan 2000 14:53:20 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Transgenic and Mad Cow Disease

PNAS USA Vol. 96, Issue 26, 15137-15142, December 21, 1999

Medical Sciences
Compelling transgenetic evidence for transmission of bovine spongiform encephalopathy prions to humans

Michael R. Scott*, Robert Will, James Ironside, Hoang-Oanh B. Nguyen*, Patrick Tremblay*, Stephen J., DeArmond*, and Stanley B. Prusiner*,

* Institute for Neurodegenerative Diseases, Departments of Neurology, Biochemistry and Biophysics, and Pathology, University of California, San Francisco, CA 94143; and National CJD Surveillance Unit, Western General Hospital, Edinburgh EH4 2XU, United Kingdom

Contributed by Stanley B. Prusiner, October 27, 1999

There is growing concern that bovine spongiform encephalopathy (BSE) may have passed from cattle to humans. We report here that transgenic (Tg) mice expressing bovine (Bo) prion protein (PrP) serially propagate BSE prions and that there is no species barrier for transmission from cattle to Tg(BoPrP) mice.

These same mice were also highly susceptible to a new variant of Creutzfeldt-Jakob disease (nvCJD) and natural sheep scrapie. The incubation times (250 days), neuropathology, and disease-causing PrP isoforms in Tg(BoPrP)Prnp0/0 mice inoculated with nvCJD and BSE brain extracts were indistinguishable and differed dramatically from those seen in these mice injected with natural scrapie prions.

Our findings provide the most compelling evidence to date that prions from cattle with BSE have infected humans and caused fatal neurodegeneration.


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Date: 1 Jan 2000 18:58:43 U
From: Judy_Kew@greenbuilder.com (Judy Kew)
From List: Biotech Activists biotech_activists@iatp.org
Posted by: blilliston@uswest.net

GE Future Products: Science Invades Pantry

By BARNABY J. FEDER, New York Times, January 1, 2000

So far, most of the inventions of agricultural biotechnology have been new weapons for farmers in their fight against insects and weeds. A few make processes like making cheese more efficient. One big seller, a cow hormone produced in genetically altered bacteria, increases milk production.

But many consumers think that there may be unacceptable health and environmental risks in biotechnology. The food industry is under pressure to show that it can produce not just more food, but also food so obviously improved that the benefits to consumers clearly outweigh any risks.

Researchers say an impressive array of such products will become available in just a few years. Some will be the result of the kind of biotechnology that makes consumers most nervous – namely, moving genes between organisms that would never mate naturally. Others will be created through traditional breeding and food production.
PRODUCTALTERATIONHOW IT'S DONEBENEFITS AVAILABLERESEARCHERS
RICE Enriched with beta carotene, which the body converts into vitamin A. Three genes – two from the daffodil and one from a bacterium – are inserted into the rice. Would reduce the one million deaths of children and millions of cases of blindness that are attributed to vitamin A deficiency in developing countries each year. In 2003, to farmers. The Institute of Plant Sciences in Zurich and the International Rice Research Institute in Los Baños, the Philippines, which will coordinate breeding and distribution.
CORN Conversion to polyester. Bacterial genes are inserted into yeast so that the end product in the fermentation of corn sugar is trimethylene glycol, a building block of high-performance polyesters A biodegradable, easily recyclable polyester that is too expensive to make with current technology. In 2004, for use in upholstery, carpeting and clothing. Scientists at the DuPont Company.
MILK Elimination of the most common allergen. Exposure to an enzyme during processing breaks down beta lactoglobulin, the allergenic protein that occurs naturally in milk. Would help the 1 in 20 children with this allergy avoid vomiting and diarrhea; would reduce the risk of occasional deaths from the allergy. In 2005, to consumers. Basic research led by Bob B. Buchanan at the University of California at Berkeley.
PRODUCE Adding vaccines for diseases like hepatitis B. Viral genes are inserted into the seeds. Would replace injections with a cheaper, more convenient means of distributing vaccines. In 2005, probably first in powdered potatoes and tomatoes. Initial research by Charles J. Arntzen and Hugh Mason of Cornell University's Boyce Thompson Institute for Plant Research Inc.
EGGS Enriched with appetite-reducing antibodies. Hens are immunized to stimulate the production of antibodies that activate peptides in the human digestive system associated with feeling full. Healthier, cheaper weight-reduction regimens. In 2005, to consumers Initial research by Mark E. Cook at the University of Wisconsin.

================================
From List: Biotech Activists biotech_activists@iatp.org
Date Posted: 01/01/2000
Posted by: blilliston@uswest.net
================================

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Date: 1 Jan 2000 19:02:35 U
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: "NLP Wessex" nlpwessex@bigfoot.com

The GM debate is by inference included at the core of the Prince's Millennium radio address today, the first day of the third millennium. Invoking the humility and respect for the natural world of great thinkers such as Albert Einstein it effectively develops into a more hopeful discourse about man's relationship with natural law in the new century.

We congratulate the Prince for having the courage to speak his mind once again at this uniquely reflective point in modern history - in particular for warning us against making mistakes of the intellect and for encouraging us to rediscover the art of living.

"........life is a more profound experience than we are told it is,"

Prince of Wales, 1.1.2000.

NATURAL LAW PARTY WESSEX
nlpwessex@bigfoot.com
www.btinternet.com/~nlpwessex

Audio version at
http://news.bbc.co.uk/olmedia/585000/audio/_586898_tftday.ram
This is the full text of Prince Charles's message on BBC Radio 4's first thought for the Day of the new millennium.

Prince Charles' Millenium address on GM and Nature

http://news.bbc.co.uk/hi/english/uk/newsid_587000/587166.stm

By Prince Charles, BBC ONLINE
Saturday, 1 January, 2000, 17:01 GMT

I suspect many of us will have been wondering how to approach the millennium, wondering what it actually means in the midst of our daily lives.

I daresay many of us will have decided what it does not mean.

Will it, for instance, be an experience, the dawning of an exciting moment when we step boldly across a threshold marked 21st Century and emerge into the golden promised land of a perennial future, where there shall be no more wailing and gnashing of teeth, where water flows uphill and the whole of humanity is genetically re-engineered?

Or will it perhaps provide a sacred moment of reflection as we celebrate the 2,000th anniversary of that unique occurence when the word became flesh and dwelt among us?

Will it remind us that each new year represents, as did Christ's mysterious birth, a microcosm of the vital process of renewal that dominates our existence?

For although our everyday lives seem to be dominated by linear time, one day following the next and year following year in an unbroken line, each new year reminds us of the importance in our existence of natural cycles, of events which continually recur.

But of course there is all the difference in the world between renewing what is old and replacing old with new.

The millennium provides us with an opportunity to abandon the poles of blind optimism on one hand and total despair on the other, and to rediscover a much older emotion - hope.

Hope belongs to a world which recognises the idea of limits - going with the grain of nature and cherishing and learning from the best of what we have inherited from the past.

In this sense, the dawn of a new millennium should not be the excuse for a bonfire of the past, but a chance to rediscover the profound wisdom of those who have made the difficult journey through this life before us. Those who, like our Lord Jesus Christ, taught that this life is but one passing phase of our existence and that the reality lies within each one of us.

Or, as Rilka put it, death is the side of life turned away from us.

In an era when we are tempted to believe that science knows nearly all the answers, it is instructive to recall that Einstein understood the close connection between wonder and the sacred.

To him the sense of wonder was the most important sense to open ourselves to the truth, the immensity of the mystery and the divinity of ourselves and our world.

He wrote that "a person who is religiously enlightened appears to me to be one who has, to the best of his abilities, liberated himself from the fetters of his selfish desires and is preoccupied with thoughts, feelings and aspirations to which he clings because of their supra-personal value".

As we enter a new millennium with all its hopes and fears, I pray that we may come to realise that life is a strange paradox and that the art of living it lies in striking a balance, and that it is a sacred thing to compose harmony out of opposites.

Two and a half thousand years ago Plato was at pains to explain, through the words of Timaeus, that the great gift of human rationality should not be disparaged. Far from it, he said, it should be exercised to its utmost, but it must not make the mistake of believing it has no limits.

In an age of secularism I hope with all my heart that, in the new millennium, we will begin to rediscover a sense of the sacred in all that surrounds us, whether in the way we grow our crops or raise our livestock on the land that God has given us, whether in the way we create places for people to live in the countryside we have inherited, whether in the way we treat disease in our fellow human beings or whether in the way we educate or motivate our young people.

But to do that we must first of all understand that life is a more profound experience than we are told it is. After all, the likelihood of life beginning by chance is about as great as a hurricane blowing thorugh a scrapyard and assembling a Rolls Royce.

Perhaps, in the midst of all the celebrations and the hype, deep down inside many of us may feel intuitively - to paraphrase a wonderful passage from Dante - that the strongest desire of everything, and the one first implanted by nature, is to return to its source. And since God is the source of our souls, and has made it alike unto himself, therefore this soul desires, above all things, to return to him.


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Date: 1 Jan 2000 23:44:53 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Commercialization of Genetic Research and Public Policy

By Bartha Maria Knoppers, Marie Hirtle, Kathleen Cranley Glass*
Science 286,2277-78

Sections:
Policy Making
Human Rights Approach
Statutory Approach
Administrative Approach
Market-Driven Approach
Particular Issues and Recommendations
Patents.
Conflicts of interest.
Conclusion
References and Notes

Policy Making

We are in the age of "Homo economicus" (1). Human genetic material is increasingly an object of commerce. For organs at least, there is some international consensus against commercial trade. However, an overview of the issues raised by human genetics reveals confusion and concern among policy-makers and the general public about the appropriateness of commercialization (2). For society to deal with these new technologies, it is crucial to evaluate four emerging approaches to policy-making and to look at possible strategies in dealing with specific issues.

Human Rights Approach

Through the filter of human rights codes, constitutions, and international conventions, this approach relies on the courts. It circumscribes the applications of new technologies that otherwise might encourage discriminatory or stigmatizing practices. Policy-oriented decisions of high-ranking courts are strengthened by the fact that public interest groups can obtain standing to participate and help case law reflect public values.

Such cases clarify issues and set far-reaching precedents in the interpretation of, for example, the right to privacy, or discrimination resulting from application of new technologies in the areas of employment or insurance. Yet, on the whole, they are ad hoc in nature and achieved after the technology has already been integrated into research and health care. Furthermore, like all litigation, the process is a costly and lengthy one. Finally, if the court is timorous and refuses to go beyond the facts or issues, it is a limited recourse.

Statutory Approach

In this method, specific legislation crafted in response to new technologies addresses the implications of scientific advances through prohibitions, constraints, or moratoria. This method has the advantage of immediate certainty, clarification, and precision, as well as being an expression of political consensus. Furthermore, such legislation can also prospectively foreclose avenues of research by prohibiting techniques such as the creation of human chimeras. The danger of this approach is that such legislation is limited to the current issues and tends to close the public debate.

Moreover, if such statutes are adopted in rapid succession, there is a risk of contradictory positions and of inadequate definitions. The latter is particularly true when terms such as "embryo" or "cloning" are defined, for example, only to find that new knowledge or different techniques escape the statutory definition. Finally, if hastily adopted because of public outcry, they will be lacking a proper foundation based on scientific risk assessment.

Genomic commercialization is becoming a reality. How will we deal with it?

Administrative Approach

A third possibility is an administrative approach through governmental or professional bodies. Such an approach allows for the gradual development of self-regulatory professional codes of conduct and, where necessary, licensing, monitoring, and quality assurance. Professionally and procedurally oriented, it ensures a "buy-in" by those involved, resulting in greater effectiveness and integration into practice.

These professional codes, ethical guidelines, and standards of practice, however, can be seen as self-serving and as a way to avoid either lawsuits or restrictive legislation. Furthermore, the public does not participate in the drafting of these codes. Another drawback of this incremental approach is that it "administers" technologies through codes or standards and usually fails to explicitly enunciate the value-choices underlying their acceptance or to explain why certain constraints have been instituted.

Market-Driven Approach

Finally, a liberal, market-driven approach maintains that proper, professional practices will ultimately "win-out" in an unfettered marketplace. This approach seems to be the most flexible and supportive of scientific research. Technological development is dependent on investment and support, either public or private.

The market, however, is also subject to lobbying by special interest groups, including those who stand to gain financially from public investment or lack of public control, and those who, for a variety of reasons, see certain technologies as potentially harmful or in conflict with their particular values. The difficulty these advocacy groups have in compromising inhibits the consensus necessary for successful, albeit limited, government-initiated oversight. This leaves the development of any given technology to the vagaries of the market, the chilling effect of litigation, and consumer choice. This is evident in the proliferation of private, unregulated infertility clinics and of mail-order genetic tests.

Particular Issues and Recommendations

Status of genetic material as it relates to commercialization. The current commercialization of the genomics revolution (3) has led to concern that turning tissue, cell lines, and DNA into commodities "violates body integrity, exploits powerless people, intrudes on human values, distorts research agendas, and weakens public trust in scientists and clinicians" (4). Respect for genetic material as part of the person and of humanity is consistent with the domestic positions of most countries.

For example, in UNESCO's 1997 Universal Declaration on the Human Genome and Human Rights (5), the genome is considered to be the common heritage of humanity. The Declaration takes no position on the issue of the status of individual human genetic material except to maintain that "in its natural state [it] should not give rise to financial gains" (article 4). Likewise regional instruments such as the European Directive on the Legal Protection of Biotechnological Inventions (6) and the Convention on Human Rights and Biomedicine (7) adopt this broad approach and consider human genetic material as part of the person and not as property.

Most countries avoid the issue of the property-person characterization. Indeed, a legislative approach as been eschewed in favor of administrative (professional) guidelines (2). The result of the administrative approach is a plethora of conflicting (if not confusing) DNA "banking" standards (10) with little or no guidance on commercialization. Moreover, as noted by a National Bioethics Advisory Committee (NBAC) report (8), DNA can be extracted from such materials, stored indefinitely and plumbed for information "to reveal something not only about the individual from whom the tissue was obtained, but possibly about entire groups of people...." (9).

The NBAC report serves to illustrate the array of different choices that have to be made in relation to the possible research uses of tissues obtained during routine care or specifically for research (and this beyond the lifetime of the person). No agreement exists as to whether participants should simply be notified of possible commercial uses, or can veto such use, or should not be told anything. NBAC has made no recommendation on either the issue of status or of commercialization but does say that the topic deserves fuller consideration.

Policy-makers should be sensitive to specific social, legal, and policy implications. Government inactivity could be perceived as endorsing a laissez-faire and market-driven approach. This would violate important societal values in most countries. Yet, in the face of the current trend toward commercialization of genetic research, extensive legislative interference could dry up the largely private sponsorship of genetic research.

Furthermore, the increasingly multicentered and international nature of human genetic research and pharmacogenomics suggests that the time is ripe for international harmonization. Although the Human Genome Organization (HUGO) has begun this effort (11), regional and international bodies such as the Council of Europe and the World Health Organization (WHO) would do well to develop a model professional code of DNA banking practices.

The continued absence of common international, professional standards on the basic choices to be offered research participants will result in the continuation of contradictory approaches and undermine the possibility of procuring fundamental population data necessary to good science and so, good ethics.

Patents.

Two approaches have appeared with regard to the issue of the patentability of human genetic material. The first, largely confined to Europe, and exemplified by the 1998 European Directive maintains that the human body or the simple discovery of some component (including gene sequences or partial sequences) are not patentable inventions [article 5(a) in (6)]. The second is market driven and leads to a situation of fragmentary and overlapping patents (12).

This occurs whether the patent rights granted are broad or limited to partial sequences. According to HUGO, this has resulted in problems because, whether broad or narrow, these rights, preclude patenting of innovative disease gene discoveries, act as obstacles to investment, and are deterrents to deposition of information into databases (13).

One way to stop proliferation of fragmentary, counterproductive patents might be for policy-makers to "activate" the public order and morality exclusion on the exploitation of patents as found the European Patent Convention (article 6.2 in 14) by incorporating this ethical filter into national legislation. This would provide a basis for refusing to grant a patent on an invention if its exploitation would be contrary to public policy.

Like the recent requirement of prior environmental impact assessment (the precautionary principle), a renaissance of this public policy filter especially in the upcoming renegotiation of the TRIPs (Agreement in Trade-Related Aspects of Intellectual Property Rights) could reinforce the exclusion from patentability of our "genetic heritage." Moreover, the European Directive (6) has advanced the debate in that it requires an informed consent to patentability from the person whose biological material is being used. This approach could be incorporated as a core element in the international harmonization of practices mentioned earlier.

In the long run, it remains for national patent offices to take leadership in a way that inhibits a totally market-driven approach from impeding international, scientific collaboration. Failure to do so will eventually lead to costly litigation and loss of potential therapeutic advances.

Conflicts of interest.

During the past 15 years, universities and health-care institutions have looked increasingly at private sources to pay expenses associated with research. Academic health-care centers conduct some kinds of research that may generate unique concerns. Principal among these is the development or evaluation of products intended for clinical application that could have great commercial value. Concern grows as the boundary is increasingly blurred between the basic research conducted in the academic health center laboratories and the derivative product development that is often in the commercial sector (16).

Commercial partnerships represent unfamiliar terrain for many university and health research institutions. They increase institutional obligations to minimize or even eliminate the potential for conflicts of interest that arise when private financial gain becomes part of the research equation. Universities and health-care institutions require strong and clear policies to deal with conflicts of interest, as well as effective ethics review bodies to evaluate human subjects research. Because research institutions themselves face potential conflicts of interest, policy-making is best handled by legislative action that would establish standards and require local institutions, both public and private, to adopt appropriate policies and review mechanisms. It should also ensure that those responsible for conflict of interest and research ethics review have adequate funding as well as sufficient autonomy.

Conclusion

Each approach has advantages and disadvantages. The choice between them, or a mix thereof, depends on the degree of public trust in their credibility and effectiveness and on the state of the particular debate. Policy-makers should frame their decisions according to the values and needs of the persons and populations who contributed to genetic research and have legitimate expectations of participating in the benefits thereof.

References and Notes

  1. D. Nelkin and L. Andrews, Hastings Cent. Rep. (September-October), 30 (1998).
  2. B. M. Knoppers, Nature Genet. 22, 23 (1999).
  3. H. T. Greely, Science 282, 625 (1998).
  4. In (1), p. 31.
  5. Universal Declaration on the Human Genome and Human Rights (UNESCO, 1997).
  6. Directive on the Legal Protection of Biotechnological Inventions (European Commission, 1998).
  7. Convention on Human Rights and Biomedicine (Council of Europe, Strasbourg, 1997).
  8. National Bioethics Advisory Committee, "Research involving human biological materials: Ethical issues and policy guidance" (NBAC, Rockville, MD, 1999).
  9. In (8), p. 3.
  10. See B. M. Knoppers, M. Hirtle, S. Lormeau, C. M. Laberge, M. Laflamme, Genomics 50, 385 (1998) and, for the United States, Appendix C in (8).
  11. International Ethics Committee, Statement on DNA Sampling: Control and Access (HUGO, London, 1998).
  12. M. Heller and R. Eisenberg, Science 280, 698 (1998).
  13. HUGO, "Statement on the patenting of DNA sequences," 1 January 1995.
  14. European Patent Convention (1973) available from http://www.european-patent-office.org/epc97/index.htm
  15. The public policy and morality exclusion is found under article 27.2 of the Agreement in Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) and likewise, under NAFTA (North American Free Trade Agreement), at article 1709(2).
  16. R. E. Bulger, E. Heitman, S. J. Reiser, Eds., The Ethical Dimensions of the Biological Sciences (Cambridge Univ. Press, New York, 1993), 294 pp.

Top PreviousNextFront Page

Date: 2 Jan 2000 04:24:40 U
From: MichaelP papadop@peak.org

Gene Researchers Face Crisis As Man's Saviour Turns Killer

By Robin McKie, OBSERVER (London) Sunday January 2, 2000

The much-hyped therapy was meant to save a teenager's life. Instead he died. Now officials say the idea is damaged.

It has been hyped as our saviour, the panacea that will rid mankind of disease. But gene therapy – the use of genetic engineering technology to alter patients' DNA – is giving its practitioners a sudden crisis of confidence. The cause lies with a simple mystery: why did a relatively fit 18-year-old drop dead four days after a genetically altered virus was injected into his liver?

The aim was to introduce genes to rectify an enzyme deficiency that Arizona-born Jesse Gelsinger had inherited.

The effect was to trigger 'a systemic inflammatory response'. Gelsinger's temperature soared to 104F, he slumped into a coma, his lungs filled with fluid, and within four days he had died, on 17 September, in the University of Pennsylvania hospital in Philadelphia.

His death has baffled gene therapists already beset by accusations that their technique has failed to live up to the hype surrounding its introduction 10 years ago.

Now they face a new problem: perhaps the very basis of their technology poses dangers to patients, a prospect sufficiently worrying to lead to the temporary suspension of many US gene therapy trials after Gelsinger's death. Understanding why he became the first person to die directly as a result of gene therapy has therefore assumed considerable medical importance, as well as being a family tragedy. 'I lost a hero,' Paul Gelsinger said of his son, who fought a long, debilitating battle against the metabolic disease for which he was being treated.

Gene therapy for humans began in 1990, when US researchers exploited science's burgeoning knowledge of human genetics to treat Cynthia Cutshall and Ashanthi Desilva, two youngsters who suffered from the same severe immune disorder that plagued John Travolta's character in the 1976 TV movie The Boy in the Plastic Bubble.

First, cancer specialists led by French Anderson and based in Bethesda, outside Washington, isolated the gene missing from the girls' complement of DNA, inserted it into a virus and used this to infect their cells – the aim being to add the missing gene to their genetic make-up. The experiment was successful, though the effect was not permanent and has to be repeated every few months. Nevertheless, the girls were transformed from sickly, housebound toddlers into exuberant, lively youngsters, and the team's triumph led to a massive hype for gene therapy with Anderson being ranked by Time magazine beside Hippocrates and Pasteur as one of history's most important physicians.

However, 10 years later, the case of Cynthia and Ashanthi remains a rare success, one of the field's notable exceptions. Three hundred clinical gene therapy trials on about 3,000 patients – involving dozens of different diseases, from brain tumours to cystic fibrosis to inherited heart conditions – have improved the lives of only a handful of people, and have yet to bring about a full cure of a single patient.

Now the therapy has killed one of them. 'There has been a massive amount of hype about gene therapy,' said Oxford geneticist Sir Walter Bodmer. 'And while it may seem a good idea to introduce missing genes into patients to cure their illnesses, there is a real problem of how you do that. Most techniques involve the use of genetically engineered viruses.

And that is where the problems begin. The viruses have to be neutralised in some way, and there is no effective way they can be guided so that they insert missing genes into the right place in patients' chromosomes.' Researchers have struggled to improve their accuracy at gene insertion but have yet to report significant breakthroughs.

In addition, they have faced the constant problem of ensuring their virus vectors are safe – and it is here that researchers at the University of Pennsylvania's Institute for Human Gene Therapy appear to have come unstuck. A total of 18 patients suffering from the same enzyme deficiency were treated with an adenovirus – a class of virus that causes colds and other conditions. The virus had been altered to carry a gene that would control their ailment but had also been crippled so as not to cause illness on its own. But the team had to give a massive dose to try to get enough of the missing gene into their patients, and Gelsinger received the biggest of all: 38 trillion particles of virus. The group still failed to get the new gene to express itself in any patients and, in Gelsinger's case, appears to have triggered a deadly reaction, though exactly how remains a mystery.

At a recent public meeting at the US National Institutes of Health, in Bethesda, the leader of the Penn team, Dr James Wilson, spent two days answering scientists' questions about Gelsinger's death to try to find the answer. Many argued that the young man's response was unusual; others suggested such a fatality was waiting to happen. 'You don't need to evoke anything weird,' Art Beaudet, of the Baylor College of Medicine in Houston, told the journal Science. The publication also quotes a federal official who admitted that the case had done 'damage to gene therapy', and reports that the US Food and Drug Administration has found 'deviations' from trial protocols that may lead to a reprimand for the project leaders.

The decision will be a blow to the Pennsylvania team but, far more important, it will underline the stark dilemmas that now beset this 'wonder science'. Either the researchers do not use enough virus and therefore find they cannot get enough life-saving genes into patients' cells or they run the risk of using too much, thus triggering an abnormal, possibly fatal, reaction. 'Gene therapy will have its uses,' said Bodmer. 'It has great potential for attacking cancer, for example.

However, as a cure-all, as a panacea, it clearly has limitations. It is far more likely that the knowledge that is now pouring from laboratories round the world about our genes will be exploited to create better and better pharmaceuticals, rather than directly tinkering with our genetic make-up. That is where the real future of medicine lies.'

*** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. ***


Top PreviousNextFront Page

Date: 2 Jan 2000 07:35:35 U
From: Colleen Robison crobison@mnsinc.com

Hi, Happy New Year!
I am posting the whole article because it is already a few days old. Glad to see Michael P's posting from the Observer today. I hope other countries will pick up this story to alert citizens. Note that Weiss/Nelson say a congressional hearing on gene therapy is planned for January.
C.

===============================

Gene Therapy: Death Raises Question of Ethics, Profit, Science

By Rick Weiss and Deborah Nelson, Washington Post Staff Writers
Friday, December 31, 1999; Page A03
http://search.washingtonpost.com/wp-srv/WPlate/1999-12/31/141l-123199-idx.html

Sections:
Gene Therapy's Troubling Crossroads
Conflicts of Interest
Glimmers of Hope
One Treatment Method

Gene Therapy's Troubling Crossroads

Sometimes it takes a disaster to remind scientists and the public just how far out on a limb they have ventured together, as happened with the Challenger explosion and the accident at Chernobyl.

Now gene therapy, the bold effort to revolutionize medicine by reshaping people's genes, finds itself in the midst of a similarly wrenching and contemplative reassessment in the aftermath of the death of Jesse Gelsinger –the first person to be killed by having his genetic code rewritten.

Ever since researchers at the National Institutes of Health (NIH) dripped new genes into a 4-year-old Ohio girl's vein in 1990 in an effort to cure her inherited immune system disorder, gene therapy has stood out as one of medicine's brightest hopes. But the conceptually simple approach, which promised a new era in which diseases would be cured at their molecular roots, has suffered repeated failures.

Getting new genes into people, and especially to the organs where they are most needed, has proven unexpectedly difficult. And getting those genes to work for more than a few weeks or months has been almost impossible.

"It's fair to say that in 300 clinical trials and 6,000 patients or so, if I had to show you a ringing endorsement that it works, there are none. That is the truth," said Inder Verma, a gene researcher at the Salk Institute in La Jolla, Calif., and one of the field's founders. "We all know now it was overblown and overhyped."

If anything gave scientists solace during their years of frustration, it was that gene therapy at least seemed safe. But that presumption was shattered in September with Gelsinger's death at the University of Pennsylvania.

Now gene therapy stands at a scientific, ethical and financial crossroads.

It is a crossroads still filled with promise, represented most poignantly earlier this month by a little-noted report that two French newborns with deadly inherited diseases appear to have had their fates reversed by infusions of new genes. Those preliminary results could turn out to be the field's long-awaited first cures.

But it is also a crossroads laden with risk. Medical risk, as became clear with Gelsinger's death. And equally important, the risk that gene therapy –which still faces major technical hurdles but is under pressure from corporate sponsors to produce a return on their investment – will speed ahead too quickly, gloss over its problems, and lose the support of a public that is already uncertain about the wisdom of tinkering with people's genes.

"Scientists call gene therapy 'elegant,' " said Thomas Murray, president of the Hastings Center, a bioethics institute in Garrison, N.Y. "But obviously it is not elegant at this point. It is damn messy, and in fact we now see it can be dangerous. Patients and research subjects need to be told about the risks, and protocols need to be approved or denied in full knowledge of those risks."

Conflicts of Interest

As with so many areas of genetic research, including cloning and human embryo research, the concept of gene therapy has long rattled society with a mix of excitement and fear.

Protesters attended many of the NIH meetings at which the first gene therapy proposal was reviewed. Some considered the experiment the ultimate act of hubris, a profound meddling in God's handiwork. Others predicted ominously that the well-intentioned goal of curing genetic diseases would grow into a high-tech quest for genetic perfection and open a new era of racist eugenics.

In part because of those social concerns, and also because of the many scientific uncertainties raised by human genetic engineering, federal officials created a higher and more public standard of review for gene therapy experiments than exists for conventional new therapies. And in September 1990, a team of NIH researchers finally got the satisfaction of overseeing the first approved infusion of new genes into a patient.

Today that patient, Ashanthi DeSilva, is a mostly healthy 13-year-old girl who "gets an occasional cold," said her father, Raj. But scientists still don't know how much of her health is due to her new genes, and how much of it is due to the immune system-boosting drug that she has continued to take since before she was given that new DNA. And since then, despite a plethora of efforts against cystic fibrosis, inherited high cholesterol, muscular dystrophy, heart disease, cancer, AIDS and other ailments, not a single patient has been cured by gene therapy.

As the field foundered, however, it also began to undergo a subtle transformation that is at the heart of gene therapy's predicament today. One of the first clues that something was changing was that researchers started to focus on cancer more than the rare genetic diseases that the field had first aimed to treat. The economics of developing a cure for cancer were much more attractive than those for a disease with just a few hundred victims. And more than ever, gene therapy was becoming dominated by profit-seeking companies rather than by academic and federally funded researchers.

In a related development, scientists who once shared their results openly at scientific meetings grew more secretive under the competitive pressures to develop the first blockbuster therapy. Increasingly, talk was of patents rather than patients. By the time Gelsinger died in September, some corporate researchers were already battling the NIH in bids to keep serious injuries or deaths in their studies from becoming public.

The University of Pennsylvania, where Gelsinger died, is in many ways representative of the new world of gene therapy. It has allied itself with several financially interlinked biotechnology companies. These firms stood to gain financially if the Gelsinger study had proved successful, including one founded by the leading geneticist in that study.

The Penn team has said that financial considerations had no impact on patient care decisions in the study and had nothing to do with the multiple violations of patient protection rules that federal investigators have uncovered – including the team's failure to properly inform the Food and Drug Administration about the side effects in volunteers that, if reported, would have forced a halt of the experiment. But some experts believe that the Penn violations are evidence that the field of gene therapy has strayed from its initial promise of public accountability.

"What happened in the Penn study should not be brushed off lightly," said LeRoy Walters, a Georgetown University ethicist and former chairman of the Recombinant DNA Advisory Committee (RAC), the NIH committee that oversees gene therapy. "It's one of the top research groups in the country, certainly one of the largest. They were in a position to know the rules better than most people. I think they betrayed the trusts of the patients participating in that trial and betrayed the trust of FDA . . . and the RAC in what they did."

The FDA and the NIH are jointly investigating whether the Penn team's lapses were exceptional or representative of the gene therapy field. But even as they try to answer that question, those agencies are under pressure from the biotechnology industry to scale back their special reporting requirements so fewer gene therapy results would end up in the public domain.

In essence, the emerging debate about gene therapy oversight comes down to a single question: Has the field of gene therapy reached a stage of scientific rigor, and has a sensitive public grown comfortable enough with the concept of human genetic manipulation, for gene researchers to be regulated as conventional drug developers? A special NIH advisory panel is focusing on that question, and a congressional hearing on the topic is planned for January.

But behind that question is a much more difficult one: How can patients and volunteers be protected, and conflicts of interest among researchers minimized, as academic medical researchers and corporate sponsors become increasingly interdependent? It's a question not unique to gene therapy, but one that has come into special focus with gene therapy because of the field's tradition of public review.

"We're dealing with a clash of cultures and values," said Murray of the Hastings Center. "The culture and values of science and the culture and values of industry, one embracing openness and the other embracing secrecy."

Glimmers of Hope

Ironically, the intense attention given to the Penn debacle throughout December overshadowed what might otherwise have been gene therapy's best news in years: A report at the annual meeting of the American Society of Hematology on what may be the field's first cures.

The experiment involved two unrelated infants born with an ailment similar to Ashanthi's. The disease leaves the immune system lacking two kinds of cells that are central to the body's ability to fight infections.

Most infants born with the disease do not live to their second birthday. But the two French boys, whose identities are being kept confidential at their parents' request, were infused with healthy versions of their faulty genes nine months ago, when they were about nine months old, and both now have the missing immune cells circulating in their blood. And in contrast to the constant infections they suffered after birth, neither boy has been sick since getting the new genes, said lead researcher Alain Fischer of the Necker Hospital in Paris.

It may be many years before scientists know if the two boys are truly cured. The new genes may have taken up residence in short-lived cells that will disappear within a few years, or the genes may simply stop working after a while.

But the French boys are not the only glimmers of hope on the horizon. Researchers from Philadelphia reported earlier this month that two patients with hemophilia, the bleeding disorder, are getting by with half the usual number of coagulation shots since they were given the blood clotting genes they had lacked since birth.

At the same time, the field is inching closer to some more controversial endeavors, including "germline" gene therapy, in which genetic changes would be made in a patient's sperm or eggs to be passed down to future generations. Until recently, that has been considered taboo because, tempting as it may be to free a family of an age-old inherited affliction, the therapy could end up causing genetic problems of its own, which would then become part of that family's line forever.

Despite those concerns, NIH officials have talked openly this year about allowing some germline efforts. And already, the NIH and the FDA have begun to review a preliminary proposal to conduct gene therapy on a fetus. That would be the world's first effort to change someone's genetic inheritance before birth.

Gelsinger's death, and all the questions about science and ethics it has raised, may postpone some of these ventures. But probably not for long, several experts agreed.

"As with the [space shuttle] Challenger, we had perhaps grown a tad bit complacent in some areas, and after the accident, we had to retrench," said RAC member C. Estuardo Aguilar-Cordova of Texas Children's Hospital. "But that doesn't mean we had to stop all space exploration. On the contrary, the fact that there has been such a punctuated sacrifice by the death of an individual can really strengthen our resolve and makes a heavier burden on us to do better and put 100 percent effort into this."

If the two French boys continue to thrive, that would produce a lot of inspiration for researchers trying to do better, Aguilar-Cordova said. He called the boys "the first sentence of gene therapy's Chapter Two."

"Chapter One was characterized by a tremendous naivete," he said. Chapter Two, he said, will be about cures.

One Treatment Method

Genetically engineered viruses inject potentially curative genes into a patient's liver cells.

A metabolic pathway is blocked in patients with a genetic disorder called OTC deficiency. Dangerous ammonia levels build up.

Genetically engineered adenovirus (with some toxic genes removed) infects liver, injecting normal OTC genes into liver cell DNA.

Altered liver cells engage in normal OTC metabolism, breaking down ammonia.

© Copyright 1999 The Washington Post Company


Top PreviousNextFront Page

Date: 2 Jan 2000 14:17:19 U
From: Mark Knapp quwieorp@yahoo.com

Jellyfish Gene in Monkey Embryo

Compiled from reports by Rob Stein, Washington Post
Science Notebook, Monday, December 27, 1999; Page A11
http://www.washingtonpost.com/wp-srv/WPlate/1999-12/27/049l-122799-idx.html

Scientists in Oregon have succeeded in splicing a gene from a jellyfish into the embryos of monkeys.

Gerald Schatten of the Oregon Regional Primate Research Center in Beaverton and colleagues used a gene from a variety of jellyfish that makes a protein that glows green in certain types of light. It was spliced into sperm from rhesus monkeys. The researchers picked this jellyfish gene because it is easy to literally see whether it is in place.

The researchers then used the sperm to fertilize monkey eggs with the aim of producing embryos that carried the gene. Within two days, almost half the embryos had the green glow.

The researchers implanted seven of the resulting genetically altered embryos into female monkeys. Only one produced a live birth, a male named George who is now six months old, and it is not clear whether the monkey has the jellyfish gene. But the research, published in the latest issue of the journal Molecular Human Reproduction, shows it could be feasible to engineer monkeys with foreign genes, the researchers said.

While the work has human implications, the researchers said they conducted the experiment in the hope of engineering monkeys that could provide better tools for studying human diseases.


Top PreviousNextFront Page

Date: 2 Jan 2000 15:48:03 U
From: jim@niall7.demon.co.uk

Monsanto, the biotech giant, is suing a Canadian farmer for "illegally" growing its GM oilseed rape. But picking on Percy Schmeiser was a very public mistake

Illustrations by James Mealing

Percy Schmeiser: Seeds of Doubt

By Mary Ambrose, business FT weekend magazine 04.12.99

Sixty-eight-year-old Canadian Farmer Percy Schmeiser was considering retiring last year, until he was slapped with a lawsuit from Monsanto. The charge was that he had grown its geneticalty modified oilseed rape.

Having grown oilseed rape "every year for 40 years", he had known something was amiss. He used to spray herbicide around the electricity poles at the edge of his farm. Later, he found oilseed rape growing there. The plants from his own seeds had died; these had withstood the herbicide. And Monsanto's rape had been designed to do exactly that.

Schmeiser realised that among the seeds he'd collected from his previous crop were some GM seeds. By planting them, he'd unknowingly contaminated his own crop, and if GM plants were

on the edges of his field, it was likely they were in the middle of it, too. It was impossible to determine the extent of the contamination, especially on a farm the size of Schmeiser s in Saskatchewan, which is 1.400 acres – as much as seven average English farms combined.

As with most prairie, single-crop farms, the land is not all apiece, so he has many neighbours, some of whom have grown GM oilseed rape: and more than one road running through his land has transported it. But Monsanto's lawyers weren't interested in how the seeds arrived on Schmeiser's farm. They told him he was being sued for using Monsanto's seeds without paying for them.

Schmeiser was dumbfounded and outraged. If anyone had asked him about it, he says he would have shown them where he found the GM plants and discussed it with them. He'd never bought any GM seeds. He'd never gone to the meetings Monsanto held for farmers throughout the area, where it has extolled their benefits, and had no idea that finding GM oilseed rape on his farm made him in any way liable.

Monsanto's lawsuit concerns patent infringement. The company is seeking profits from Schmeiser's farm which his lawyer understands to mean profits from his 1998 crop. Monsanto is seeking the return of "all seeds or crop" containing the patented genes, and punitive damages for illegally obtaining the seeds, plus the company's court costs.

It is impossible to separate a few plants out of an acre of oilseed rape, and Schmeiser believes that the GM oilseed rape is on every part of his huge farm. So the biotech company may he asking for his entire yield. "That's what's really frightening," says Schmeiser. "How can somebody put anything on someone else's land, then say it's theirs and 'We'll take it, we'll sue him, we'll fine him'."

Monsanto may have sounded a warning bell to other farmers, but Schmeiser calls it "a patent entrapment". It was the first time Monsanto had sued a Canadian farmer and, in the slim frame of Percy Schmeiser, Monsanto made a dangerous enemy. Schmeiser is no country yokel, easily bamboozled and intimidated. He had been the mayor of the nearby town of Bruno for many years. He's been a member of the provincial parliament. He wants his children, the fourth generation of Schmeisers, to work the farm, to inherit it, as he did. And he insists that he didn't watch his grandparents clear the land and build a farm just "to have the profits taken over by a big multinational".

With help from his brother, a well- respected constitutional lawyer, Schmeiser countersued, alleging that Monsanto had defamed his character. Monsanto did not put a dollar figure on its suit. Schmeiser did. He's suing for C$10m (£4.2m) in punitive damages for the "arrogant, high- handed and shocking conduct" of Monsanto. The suit cites the company's "callous disregard for the environment" by introducing GM oilseed rape into his community, defamation of his character, money lost through being forced to change his farming practices, and the cost of clearing his farm of GMOs. Mediation efforts have collapsed, and the case is expected to come to trial next summer. But Schmeiser thinks that Monsanto will try to settle rather than submit to the further publicity of a trial.

As manager of a large farm- machinery dealership. Schmeiser knows "thousands of farmers", and he believes he's being made an example of because other farmers have found unwanted GM seeds GMon their farms.

"We have been told by the National Farmers' Union that there are dozens of Percy Schmeisers out there receiving threatening letters," says Jennifer Story of the Council of Canadians, a watchdog group.

The unwanted seeds, Schmeiser suspects, blew in from a neighbour, who, in 1996, had planted the then new GM oilseed rape so close to Schmeiser that there wasn't "even a fence line in between".It's also not unusual for farmers to transport oilseed rape uncovered. Schmeiser says a scientist who worked with Monsanto had assured farmers that, if its oilseed rape seed flew out of a truck, it couldn't travel very far. "1 wonder if he's ever been in a snowstorm or a sandstorm," muses Schmeiser. "There's wind on the ground, too, and it'll spread."

Schmeiser believes that another farmer told Monsanto about seeing its oilseed rape on his land, where it had survived herbicide spraying. Indeed, Monsanto, by its own admission, has received many calls from farmers. Monsanto vice-president Ray Mowling told CBC Radio, in an interview quoted in Schmeiser's suit, that the company had received about 30 tips from farmers about its oilseed rape being planted without permission.(Despite repeated efforts, no one at Monsanto Canada agreed to speak to 'the business'.) "They're pitting farmer against farmer and destroying our serial fabric," says Schmeiser.

Whatever lesson (not to mention money) Monsanto might have hoped for by suing Schmeiser has been lost in lawyers' fees and bad public relations. Schmeiser himself has become a cause celebre in north America, and was recently filmed by French television. He keeps up a constant campaign, recently writing to MPs asking how a company could actually "own" a plant, even if its gene was in it.

But, while Schmeiser may not have wanted Monsanto's crop, many other farmers did. About 60 per cent of the oilseed rape grown in the Canadian west is GM. Many farmers embraced it to increase their margins. For many, the past few years have been disastrous. The drought on the prairies has been worse than in the depression of the 1930s. The low price of oilseed rape has been compounded by a much lower level of government subsidy (9 cents per acre, per year) than American (38 cents) or European farmers (56 cents) get. And there is very little emergency money from the government available for farmers when they are up against it. This means that bigger farms can hold out longer against Monsanto's blandishments. But for small farms, running on small margins – as Corey Oilikka, president of the Canadian National Farmers' Union, says: "Anything can make the difference."

Many farmers have happily chosen a crop guaranteeing a higher yield and requiring less herbicide. (Monsanto says 20,000 Canadian farmers grow its products. Schmeiser says that's a figure from the first year of GM- production, and it has since dropped considerably.) "Cleaner fields, higher yields", was the promise.

What no one predicted was that the rest of the world might not want GM- altered rape. Given that Canadian farmers' crops make up 80 per cent of the world's oilseed rape, this was a serious blow. In less than eight months, the price of oilseed rape has dropped by C$4 a bushel from an average of C$9 a bushel. Oilikka says:

"Farmers are beginning to question the profit-making potential that's shutting them out of markets." When a big American rape exporter asked farmers to segregate their non-GM crops, it was shocked. More than half the soybean and 75 per cent of the corn in the US is GM.

It could be argued that farmers knew the risks when they chose to grow GM crops. Perhaps they should have asked more critical questions. Even if farmers grow their GM crop separately from the non-GM, they cannot guarantee, or even label, any of their oilseed rape as GM-free. They didn't think they would ever need to separate it. The growers were confident that the Canadian government's endorsement meant the crop was safe for human consumption. But Jennifer Story points out that since Monsanto won't make its data available, the Canadian public "can't have access to the information that was used to make the decision on whether the food was safe."

Story feels that some consumers are also reluctant to demand more information in case they're construed as criticising farmers. Now some farmers are stuck with a crop which, says Schmeiser, takes from five to 10 times the normal amount of herbicide to kill. He says prairie farmers are calling it "a new noxious weed".

The farmers' love affair with GM crops is understandable. As in Britain, the biotechnology industry has been welcomed by Canada's government, initially as an environmental saviour. Even the most anti-GM food protester admits that they've conducted interesting research into "bio- remediation" – growing organisms which could help reclaim toxic sites, developing plants for growth in abandoned mine sites, and organisms which eat spilt oil. The biotech business is also involved in exciting pharmaceutical work. Food, originally, was only a small pan of the business. But not for long. The Candian biotech industry has grown to 500 companies, 25,000 employees and an C$800m revenue, a third of which is in agriculture.

The government sees it as a source of high-tech jobs and research, and has backed its support with money. The exact extent of the financial support to the industry is hard to calculate but, according to Statistics Canada – the government statistics bureau – biotechnology receives C$314m annually from the federal government. In 1997-1998, it reported that "virtually all (99 per cent) of the biotech expenditure was devoted to research and development".

Friends of the Earth (FoE) wants the government to give the organic- farming movement C$17m, arguing that it has stacked the deck by financing only one part of the agriculture industry and limiting the consumer's choice.

Giving consumers a choice is the one modest goal to which all the environmental groups in Canada aspire. They want the estimated 60 per cent of food containing GM products which is available on Canadian grocery shelves to be labelled as such. They hope this will spark at least public awareness, and at best concern.

At the moment, there is little demand for non-GM produce – if supermarkets are anything to go by. Organic produce is rarely available; Canadians tend to trust the government to look alter their health. They have not had the BSE crisis which led many Britons to conclude that their government had misled them about what was safe to eat. "If this were 10 years ago, before the BSE crisis," Pete Reilly of FoE UK admits, "there would have been a stampede" to get into growing GM crops.

In an effort to calm public health concerns, Tony Blair has extended the moratorium on growing GM crops from one year to three. But will the current crop trials put fears to rest? According to many scientists, they shouldn't. The trials are testing for the impact GM crops could have on the bio-diversity of the British landscape. But one fence has already been cleared. In the UK, GM foods have been passed as safe to eat by the advisory committee on novel foods and processes, which reports to the Ministry of Agriculture, Fisheries and Food. This is what concerns toxicologists, such as Vyvyan Howard, a lecturer in foetal and infant toxico- pathology at the University of Liverpool.

Howard believes that the testing of GM food's safety has been woefully inadequate, and crop trials aren't the complete answer. He says: "There is very much more they could do in the laboratory than is being done." The American US Food and Drug Administration may have deemed GM foods safe, but it recently leaked documents showing that some scientists were concerned they were approved too rapidly. As Howard points out, the FDA "does no follow-up tests", and is currently being sued by the American Centre for Food Safety.

Philip Regal, ecology professor at the University of Minnesota, was quoted in Canadian Business magazine as saying that the US government found it too hard to test genetically-modified organisms and "just gave up", characterising the approach as one of "If the people want progress, they're going to have to be guinea pigs."

The long-established and rigorous procedures for testing drugs are, to Howard's mind, the way in which GM foods should be tested. "The only way that you can test for human allergy is to have human-feeding trials. That is what you do with pharmaceuticals."

He says that we should err on the side of caution, as once these plants are released, there is no turning back. 'What we're worried about is subtle, long-term, low-dose toxicology. Because what we see in the [biotech industry and government] plan is to change every single staple in the human food chain – soya, cereals, potatoes." Or, as Schmeiser puts it, Monsanto wants "control of the seed supply which would give them complete control of the food supply". Howard believes that too much of the government's confidence is based on "risk assessment". "Too many decision-makers see it as the same thing as hazard assessment. But it's not necessarily based on science. It's opinion – usually from the industry." He compares it to the archaic system of food-tasting. When the food taster keels over after eating, you draw your own conclusion about the safety of the food. A GM food taster would, for Howard, be a "direct hazard assessment of biological systems".

His worries carry weight because there are so few truly independent scientists testing CM products. Most of the government's conclusions in Canada are based on the industry's own research. The current UK trials are being conducted by the government, but all subsequent tests are to he carried out by GM-food manufacturers, and then checked by the government. Each crop trial costs at least £1. 1m which is one reason the government will now he relying on industry data.

On October 18, more than 200 scientists working in the area of food health for the Canadian government signed a petition to the minister of health saying their inability to test products for themselves put the health of Canadians at risk. Days later, the award-winning science broadcaster and geneticist, David Suzuki, said in a speech that eating GM foods is "a massive experiment", the results of which will not be known "until millions of people have been exposed to these foods for decades".

The testing of these plants may be open to criticism, but the government warns environmental groups that the more they continue to rip up trial crops of GM products, the less Britain will have to add to the EU debate, one way or the other, about the future of these products. Yet when the advisory

Committee of Releases to the Environment, which is conducting the crop trials, declares that if ,"in the unlikely event", pollen from GM crops travelled into a non-GM crop of the same plant, the risk to human health and the environment is "none", one wonders how it can be so sure.

The committee uses isolation distances of 200m, as agreed by Scimac, the umbrella group monitoring the trials of GM foods, which includes both farmers and : industry. In oilseed rape, it asserts, this guarantees seed purity "in excess of 99 per cent'.

But tell that to Percy Schmeiser. "It's pretty windy here in the prairies," he says, drily.

Brewster Kneen, a sheep farmer for 15 years, with degrees in economics and divinity, is the author of 'Famaggeddon: Food and the Culture of Biotechnology'. He sees the move towards acting first and responding to the fall-out later as "the arrogant pride that dominates the biotech industry – that 'Oh, we know what we're doing, and if we make a mistake we'll correct it with another technology'."

British environmentalists hope that, even if the biotech-agriculture industry clears the few hurdles left in the UK, GM food will not necessarily succeed. According to MORI, health tops the list of most shoppers' concerns; hence Salisbury's description of organic produce "as the fastest-growing sector in British supermarkets". Worth £340m last year, it is expected to rise still further.

In Canada, government scientists and Monsanto stress that they have tested GM foods under international standards, using the best science available. But are we asking the right questions? wonders Sheila Forsyth, a biologist and agricultural food scientist who worked on the guidelines: "We have to develop regulations along with the science." And Pete Reilly, of FoE, says that "if a big farmer like Percy has problems, you can bet a farmer in Norfolk is facing trouble."

So what price the possibility of keeping any farms GM- free?

Percy Schmeiser is gloomy. "If one farmer gets it in Europe, in just a matter of years, there'll he nobody who won't have contaminated crops – whether they like it or not," FT

[Box: Percy Schmeiser's law suit has made him a star of the air- waves in north America and he appears on TV and radio programmes. He even has a website dedicated to him, http://www.fightfrankenfood.com) though he admits he's never seen it") don't even have a computer." he says]


Top PreviousFront Page

Date: 2 Jan 2000 23:42:08 U
From: "j.e. cummins" jcummins@julian.uwo.ca

The information below may be useful as a file.Europe recently lifted the moratorium on plant patents.

Crops patented worldwide

NATURE, VOL 399, 3 JUNE 1999

Sir,

Consolidation in the agrochemical and seed industry continues to shorten the list of owners of 'enabling' intellectual property for plant genetic modification and molecular biology. Six major groups of multinational companies are poised to develop and patent agronomically important plant genes identified in genome sequencing programmes for crop improvement (see page 396 in this issue and ref. 1).

The ensuing cascade of patenting will have important implications for technology access and global food security. We report below on the ownership of patent applications with claims for DNA sequences from the world's major crops. The finding that most patent applications have been filed by industry suggests that a strong advocate for the developing world will be needed to establish partnerships between industry and public laboratories to ensure that the benefits of genetic-modification technology will be widely available.

This should be broadly achievable within the current patent regime, but we urge patent holders to be aware of their wider responsibilities when considering licensing terms. We analysed patent applications with a filing date between 1980 and 1996 that make claims to DNA sequences (GENESEQ and World Patent Index databases, Derwent Ltd). The search, limited to 78 plant species of economic or scientific importance, revealed 601 patent applications containing one or more DNA sequences from 60 species. About half have been granted. About three-quarters of the applications were filed by 115 companies. Half of this total (48%) were filed by 14 multinationals. Recent corporate acquisitions by Monsanto have resulted in the company having the largest stake, with 69 applications, followed by Zeneca and Novartis.

Twenty-eight per cent of applications were filed by public-sector institutions. Over half of these are US owned. Four US universities and the US Department of Agriculture are in the top ten public institutions. In Europe, it is research institutes rather than universities that have sought to protect their inventions. Although the UK John Innes Institute and Germany's Max Planck and Institut für Genbiologische Forschung institutes have together filed half of the European public-sector total, Europe's stake is relatively low at a quarter of the world public-sector share. Public and private US organizations have 43% of the total, compared to 25% for Europe and 19% for Japan.

Maize was the most heavily patented species, claimed in almost 10% of the total, closely followed by the model plant Arabidopsis. About 40% of the patent applications included claims for cereals and pulses, one-third included fruit and vegetables, while claims to oilseed and model plants occurred in about one-quarter. Species used for fibres, beverages, herbs and spices accounted for the rest (10%). The overall total exceeds 100% because some applications include more than one species.

Patent applications were not confined to crop species grown in developed countries. DNA sequences from nutmeg, cinnamon, rubber, jojoba and cocoa have been claimed by inventors from developed countries. The applications, which rarely claimed more than one sequence, were dominated by genes associated with nutrition (20%), pathogen resistance (20%) and gene regulation (18%) (Table 1).

Those in nutrition included genes that determine the amount or type of sugar, starch, oil or protein in the plant, encode enriched proteins, and reduce the level of allogenic proteins in rice. Genes that contribute to pathogen resistance encode a wide variety of enzymes including chitinases. Regulatory DNA sequences in the form of transcriptional promoters are claimed that are in general tissue-specific. The gene sequences regulated by these promoters are also claimed in some cases.

Plant development and reproduction are of central importance to plant breeders, and 10% of applications fell within this class. Several concern modification of ethylene

Table 1: Predominant functions claimed for plant genes in the 601 patents analysed

Nutrition109
Pathogen resistance106
Regulatory DNA sequences97
Growth and morphology56
Sterility45
Herbicide tolerance36
Ex-plant production30
Antisense24
Plants as producers22
Environmental21
Colour20

Some patents are counted in more than one category. A further 69 patents covered fibres, diagnostics, mapping and miscellaneous categories..© 1999 Macmillan Magazines Ltd

production and the extent and pattern of flowering. Genes that confer male sterility are of particular value to the breeder, and account for about 8% of applications.

Although much of the controversy surrounding genetically modified crops concerns herbicide tolerance, only 7% of applications relate directly to this trait. These include genes encoding glutathione S-transferase IIIc, acetolactate synthase, lycopene cyclase and a protein conferring glyphosate resistance. The complexity of gene function is well illustrated by the acetyl-CoA carboxylase gene, which confers herbicide tolerance in monocotyledons but is claimed primarily for regulating oil content.

S. M. Thomas*, M. Brady, J. F. Burke *Nuffield Council on Bioethics, 28 Bedford Square, London WC1 3EG, UK Science Policy Research Unit and Department of Biochemistry, University of Sussex, Brighton BN1 9QG, UK

1. Nuffield Council on Bioethics Genetically Modified Crops: Ethical and Social Issues (NCOB, London, 1999).

Papers should spell out authors' roles