Genetically
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21 August 2000

Table of Contents

The Next US President and globalisation.
BIOWATCH: Conflicts of Interest in Biomedical research are Pervasive
U.S. Weighs Changes in Rules on Drug Research Conflicts
Biotech handouts: Tainted alliances
The Promise of Biotechnology – the Threat of Genetically Modified Organisms.
How it Happened that we don't regulate Biotech.
BIOWATCH: Scientists cautioned about genetically modified food
'Frankengrass' creates multi-coloured lawns

Top NextFront Page
Date: Mon, 14 Aug 2000 22:24:50 +0200
From: ekogaia ekogaia@iafrica.com

The Next US President and globalisation.

http://www.stratfor.com/SERVICES/giu2000/081400.ASP

Sections:
Summary
Analysis
Economic Growth
Nationalism Is A Bothersome Annoyance
Growth cannot last forever
Clashes ahead

The Unspoken Issue: The Impact of Globalization

Summary

Last week, The Weekly Analysis probed the underlying foreign policy challenges of the American presidential election. This week, the second part of this series examines the most potentially divisive - and unspoken – issue of all: globalization. As the Democratic Party meets in Los Angeles, this issue is at the root of the next president's choices on foreign policy. And this is the one thing neither major candidate will dare discuss.

Analysis

With the economy booming and foreign dangers distant, the American presidential campaign is unlikely to attempt to move many voters with issues of foreign policy. This reflects an elite consensus on U.S. foreign policy: The international system is driven by economics, which is increasingly global, integrated and interdependent, and this is all for the good. This has been the American elite consensus for a decade.

But there is a powerful undercurrent running both through American politics and politics abroad, one that angrily and profoundly rejects this narrow economic prism for viewing the world. The speed and power of the flow of capital in the last decade has raised economies – and destroyed them. In the United States itself, a small, noisy but potentially powerful movement is rising, rejecting the cliche that a rising tide lifts all boats. Some, the leaky ones, get sunk.

The effects of globalization are among the most important legacies of the last decade. And yet they are the ones that are either accepted as undeniable fact by proponents, in multi-national corporations and government, or swept under the rug.

This is the case in the American presidential campaign: Both major candidates running for office offer the same foreign policy. Only one man will be president, and he will have to wrestle with the effects of globalization, both at home and abroad. And yet neither will talk about it. It is unlikely that at any time this week in Los Angeles, Vice President Al Gore will stop to publicly dwell on how badly the Thai economy has been ravaged, or how dislocated U.S. workers will find their place in the information economy.

The primary mission of Washington's foreign policy has been to prevent side issues – like political-military ones – from interfering in the expansion of the world trading system. As a result, questions over Taiwan or human rights have been essentially shut out of the dialogue with China. Exceptions can be found in the rogue nations, led by governments impervious to economic pain and subject to sanctions and military action at the hands of the international community.

The result of this strategy is a remarkably contiguous U.S. foreign policy since the end of the Cold War, whether steered by the Bush or Clinton administrations. Both did everything possible to prevent the disruption of relations with China. Both have done everything possible to use institutions – like the International Monetary Fund –to diffuse power from individual nations. Under Republican and Democratic presidents alike, Washington led coalitions to war against rogue countries like Iraq or Yugoslavia, or to control dysfunctional economies, like Indonesia's.

In the 2000 campaign, both George W. Bush and Al Gore are completely committed to the pursuit of this same foreign policy. This is the ideology not only of the American elite, but the ideology of the global elite, as well. Indeed, it is not only an elite perspective. In advanced industrial countries, this ideology has mass appeal.

But it does not have universal appeal. Throughout the world, there are groups, though marginal, that are deeply opposed to this ideology. Moreover, the application of this ideology is increasingly difficult for major international leaders. Russian President Vladimir Putin and Chinese Prime Minister Jiang Zemin are examples of leaders torn by a globalist ideology they genuinely accept – but find increasingly painful to pursue at home.

Two forces are in play against globalization. First and most immediate, are the national interests abroad. It is possible to quickly construct a patchwork map of places essentially wiped out or left behind by globalization. This includes much of Northeast Asia in 1997, all of Southeast Asia even today, the whole of South Asia, with the possible exception New Delhi, nearly the entire African continent and at one time or another huge swaths of Latin America, including Mexico and Brazil. All in all, nearly 1 billion of the earth's 2 billion people have been hit head-on by the wave of creative destruction.

Second, are the social movements within nations that represent classes harmed by globalization and objecting to it on their own ideological grounds. This opposition is far from dominant but it is there, it is real and it can be heard.

In fact, it promises to be loudly present outside the Democratic National Convention in Los Angeles this week, where tens of thousands of protestors will provide flashbacks of the World Trade Organization protests in Seattle – only to be dismissed as a meaningless movement of malcontents. Malcontents they may be. Meaningless? In this election, almost certainly. But meaningless in the long run? No.

Economic Growth

The central thesis of globalization is this: Removing barriers to trade will increase the collective wealth of humanity. Underpinning this are three prior assumptions:

  1. Economic well-being is by far the most important consideration in social life. The ideology of globalization assumes that national impulses are primitive, tribalist hangovers and that the desire of say, Indians to have an economy not dominated by German corporations is a disease to be cured.

  2. Economic growth is desirable regardless of social disruption. The United States came into existence as a social disruption and has institutionalized it. While it works in the United States it is not clear that disruption will work equally well elsewhere.

  3. The distribution of economic benefits is less important than the aggregate benefits of free trade. Unsophisticated advocates ignore harm and look at total growth rates. More sophisticated advocates acknowledge harm and emphasize the need for all to benefit – but they ignore relative growth inside and between countries.

In short, globalists are simply and willfully ignoring the realities of politics.

Nationalism Is A Bothersome Annoyance

To them, nationalism is a bothersome annoyance. And yet, the most important lesson of the 20th century is that the proletariat does have a country and that national loyalty is more important than class loyalty. Both world wars and the national uprisings against the Soviet empire are proof enough. Ironically, it was the greatest classical economist, Karl Marx, who memorialized a phrase now essentially etched on Wall Street and Pennsylvania Avenue alike: "Capital has no country."

In reality, though, Marx and enthusiasts for globalization aside, nations do matter. And within nations, the sense that leaders have betrayed the national interest in favor of an internationalist ideology also matters. This does not matter nearly as much during times of wild prosperity – as the United States is experiencing today – as it does during periods of economic pain.

But even in a period of tremendous prosperity, witness the two marginal candidates in the presidential election: Pat Buchanan and Ralph Nader, two men with diametrically opposed personal and political histories, who have arrived at very similar positions on globalism and nationalism. The rhetoric differs; Buchanan sounds a nationalist note where Nader sounds a class tune. But both strike out at the consensus on globalization represented by Bush and Gore.

Growth cannot last forever

These movements are certainly marginal today. That does not mean they will remain so, however. The global economy is increasingly out of synch, de-synchronized. The enthusiasm for globalization in the United States is not reflected in Asia. In the heart of Europe, in Austria, a major nationalist and definitely anti-globalist movement has achieved striking electoral success in the midst of a barrage of criticism from the rest of Europe. In Latin America, indigenous movements, students and others have sounded their suspicions.

The kind of growth rates being experienced in the United States today will not – cannot – last forever. What goes up must eventually come down. Certainly, the core prosperity will continue for several years, but given coming demographic shifts – the impending retirement of the Baby Boomers in the United States – it is reasonable to expect major secular shifts in the American economy over the coming decade.

And the withdrawal of vast amounts of money from the capital markets will create a different political dynamic in the United States – both at home and abroad. The great American geopolitical choices in the coming decade are withdrawal, collective security and balance of power. When things cool, choices will have to be made – not merely about economics, but about security and politics.

Clashes ahead

At that point, later in this decade, the advocates of globalization and those suspicious of it will clash, both abroad and in the United States. The next American president – unlike his two most immediate predecessors – will have to wrestle with this powerful conflict. For the first time the elite will find that their approach to foreign policy is not universally supported; those masses that have bought into it will begin to second guess themselves – and their leaders.

The two major parties will at that time be caught in the cross currents. Republicans who helped foster a global economy will be forced to defend it. But the Democratic Party will stand to lose the most. After all, it has hammered an unwieldy coalition out of the financial elite in New York and labor unions in Michigan. That coalition will be stressed severely, when the dynamics of globalization begin to change.

Regardless of the party in power, the president – whether the occupant of the White House in 2001 or his successor – will be forced to readdress the foreign policy that has so easily underpinned successive administrations. Coalitions will be harder to forge, multinational institutions will be even more unwieldy. Close allies will become fierce economic competitors.

Already, these currents are building like eddies in the backwaters of a great river, in places as disparate as Jakarta and Vienna. And in Los Angeles, too. Whether you agree or disagree with the demonstrators in Los Angeles is irrelevant. Listen carefully to them. They will be vying for power in the United States in the coming generation, and holding power elsewhere. The debate over foreign policy will no longer be between left and right, but between globalists and their critics.


*** 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. ***

Whilst all attempts have been made to check the sources and references in the articles above, the responsibility for the accuracy of all articles lies with the originators and not with this list. Sources are given when possible

"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector," THE LANCET, April 2000

"When a butterfly flaps its wings in Africa, it can cause a hurricane in New York."


Top PreviousNextFront Page
Date: Thu, 17 Aug 2000 12:57:44 +0200
From: ekogaia ekogaia@iafrica.com

Greetings all,

Here is an article which clearly states the lack of both transparency and independence of "science" in the USA. I suggest that the situation is even worse in SA. This would explain why certain persons connected to the GE industry in SA have recently had the gall to say that GE food is 100% safe. I recently read a great piece of advice given by father to son, the son now being one of the worlds leading quantum physicists.

It is this; "never believe anything anyone tells you without checking again and again". This is an excellent maxim to bear in mind when dealing with the duplicity and obfuscation coming from the SA GE promoters. Check out who is behind FLAGS, FACS and other groups promoting GE from behind a veil of opacity, masquerading as independent and informed and non-aligned and so forth.. Check who is pulling the strings? The last thing that was 100% safe was smoking, then it was nuclear energy! Now its GE. Give me a break! Glenn Ashton.

BIOWATCH: Conflicts of Interest in Biomedical research are Pervasive

From: Vera Hassner Sharav, President
CIRCARE: Citizens for Responsible Care & Research, a Human Rights organization
Tel. 212-595-8974    FAX: 212-595-9086    veracare@erols.com

Federal government agency heads – including the FDA, NIH, CDC – have finally noticed the "elephant" in biomedical research – i.e., Conflict of Interests and intentional bias. Those conlicts confound the entire research process as scientists conducting clinical trials have financial interests in the products. As a result, human subject protections and the integrity of the research findings are undermined. By extension, the safety of the general public also suffers – when physicians – who rely on the biased published findings – prescribe new drugs that may be worse than existing ones.

At a conference convened by the Dept. of Health & Human Services, Dr. Marie M. Cassidy, of George Washington University, represented CIRCARE during public comment period. Dr. Cassidy contrasted the safeguards afforded laboratory animals – under the National Animal Welfare Act of 1966 – with the lack of protections afforded human subjects. She said, "the firewall in research with human subjects has been breached."

Dr. Thomas Bodenheimer "The evidence I have shown makes a reasonable case that scientific misconduct does take place in clinical drug trials, that conflict of interest is a risk factor for scientific misconduct, and that something must be done about it."

Following the article in today's NY Times, are CIRCARE's recommendations.


Top PreviousNextFront Page
Date: Thu, 17 Aug 2000 12:57:44 +0200
From: ekogaia ekogaia@iafrica.com
From: CIRCARE

U.S. Weighs Changes in Rules on Drug Research Conflicts

By PHILIP J. HILTS, The New York Times, August 16, 2000, p. A-28
http://www.nytimes.com/library/national/science/health/081600hth-....

BETHESDA, Md., Aug. 15 – The huge influx of money into biomedical research is creating unacceptable conflicts of interest for scientists and is eroding the public's trust in the data, scientists and officials said today at a government conference.

The meeting was convened by the Department of Health and Human Services to consider strengthening guidelines on conflict of interest in medical research.

Dr. Jane E. Henney, commissioner of the Food and Drug Administration, said some researchers testing drugs or therapies have profitable arrangements with companies financing the research, raising the question of whether the data is unbiased. Citing the death of a patient in a gene-therapy experiment last year, Dr. Henney warned that "if a crisis in confidence develops, if research subjects no longer feel safe, then medical research will grind to a halt."

David Korn, a senior vice president at the Association of American Medical College, warned that if medical researchers and professional associations did not establish guidelines on research involving human subjects, the federal government would do it for them.

Dr. Korn said a decade ago, the government tried to impose rules on how and when scientists could accept money or stock while working on a company's products. But researchers successfully lobbied against the proposal. Instead, there is a rule that suggests that if a scientist has such a conflict, it should be reported, confidentially, to the university.

Now, he said, such confidential disclosure was probably not enough to keep the public's confidence. Rules should be made prohibiting some behavior, he suggested. For example, some universities now prohibit scientists from being an owners of a company whose drug or treatment they are testing.

Dr. Thomas S. Bodenheimer of the University of California at San Francisco and a contributor to The New England Journal of Medicine, said today that he had spent a year reviewing literature and interviewing researchers and drug officials.

What he found, Dr. Bodenheimer said, was that when drug companies paid for a trial of a new drug, 89 percent of the time, the studies found that the new drug was better than ones it was replacing.

But when tests were done by scientists who were not paid by the company, the new drug received good marks only 61 percent of the time.

He said he also found that some articles published in medical journals were written not by the researchers who conducted the studies but by a ghost writer at the company whose drug was being studied.

In other cases, he said, well-known doctors were hired to be guest authors on studies they had not conducted.

Dr. Bodenheimer cited a survey of six major medical journals in 1996 that found that of the 809 articles, 29 percent had guest authors, ghost authors, or both.

He said he had concluded that "biases can be, and have been, intentionally introduced that favor the company funding the study." "How often this takes place we do not know," Dr. Bodenheimer said. "The evidence I have shown makes a reasonable case that scientific misconduct does take place in clinical drug trials, that conflict of interest is a risk factor for scientific misconduct, and that something must be done about it."

© Copyright 2000 The New York Times Company

~~~~~~~~~~~~~~~~

Citizens for Responsible Care & Research (CIRCARE) oppose unethical research.
Tel. 212-595-8974    FAX: 212-595-9086    veracare@erols.com

We support research that is conducted in accordance with ethical and professional clinical guidelines, that is respectful of the rights and dignity of every human subject. We oppose experiments which exploit the vulnerability of disadvantaged persons, such as the uninsured, the mentally disabled, veterans, and children. We oppose research that violates the human rights, welfare or best medical interests of patients in the name of science. We therefore call for the following national reforms:

  1. A moratorium on symptom provocation experiments (i.e., "washout," placebo, "challenge") in schizophrenia research which exacerbate a severe, incapacitating, life-threatening illness. Such experiments are not acceptable in patients with any other life-threatening condition they should be stopped in neuropsychiatry.

  2. Enactment of A National Human Subject Protection Act to provide legal and ethical safeguards for all human subjects in experimental researchensuring that in all clinical research, all patients are provided the best diagnostic and therapeutic methods available. Safeguards for human subjects should be at least equal to those currently provided to laboratory animals under the National Animal Welfare Act of 1966.

  3. A prohibition on conducting above-minimal-risk experiments on vulnerable persons who are incapable of evaluating the risks or appreciating the consequences themselves unless they can be demonstrated to be in these patients best interest. Mental capacity should be assessed by an independent physician.

  4. Establish an independent federal review board with at least 33% non-scientists to provide guidance and oversight for research involving patients-regardless of funding source – to ensure that our public policy and community values are upheld. Approved research designs should be open to public scrutiny.

  5. Require a no-fault personal injury insurance for every human subject of research to cover the duration of the research and one-year following completion.

We believe such insurance, in the amount of about $250,000 per subject (premiums to be paid by the sponsor/ research team/ institutions) would be an incentive to reduce unnecessary risks and would compensate individuals / family for undue harm. It would also reduce the taxpayers burden for uninsured persons who may require costly after-care as a result of experimental adverse consequences.


Top PreviousNextFront Page
Date: Sat, 19 Aug 2000 18:05:42 +0200
From: "taynton" taynton@cdrive.co.za

Biotech handouts: Tainted alliances

By Arthur Allen
http://www.salon.com/health/feature/2000/08/18/conflict_of_intere....

Like many academic scientists, John W. Norton supplemented his salary by giving talks sponsored by drug companies. A few nights a month the University of Mississippi psychiatrist would drive to some town in the boondocks and, over rubber chicken dinners, lecture the local general practitioners about antidepressant medications. Norton made an earnest effort not to promote any particular company's drugs, and when the $500 checks arrived in the mail a few weeks after each talk, he'd cash them without the slightest qualm about his scientific objectivity.

But the sweet arrangement changed in February, when Norton published a brief article on the sexual dysfunction triggered by the very drugs whose makers were paying his honoraria. After the article appeared, Norton's career as a pharmaceutical educator came to a sudden end.

"My invitations to speak suddenly dropped from four to six each month to essentially none," Norton says. "As the father of five children, I began to feel uneasy."

He found himself seeking out drug company representatives to tell them he was "still on the team," and even looking for reasons to prescribe their drugs. "I had deluded myself into thinking I was educating physicians and not being swayed by the sponsors," he says. "I was naive about what was at stake" – i.e. the millions of dollars in profits that come from antidepressant drugs.

Norton's wake-up call is an echo of the alarms sounding throughout the biomedical community, where researchers are starting to realize the extent to which their livelihood is reliant on commercial interests. Changes in the structure of medicine in recent years have meant that funding for research increasingly comes from the drug industry. Researchers and the universities they work for are often stakeholders in the products they are supposed to be testing with objective distance. Just because research is funded by drug companies doesn't mean it's inaccurate. But investigators are starting to detect patterns of research bias with subtle and obvious effects on the treatment of patients.

***********************************************************************
THIS EMAIL FROM:
Andrew Taynton, SAFE FOOD COALITION
P O Box 665, Linkhills, 3652, KwaZulu-Natal, Republic of South Africa;
tel: 031-763 2634, Cell 083 662 0411, e-mail: taynton@cdrive.co.za
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References On Genetically Modified Foods And Crops + What You Can Do.

  1. "Scientists and Physicians for the Responsible Application of Science and Technology" call on all Governments to immediately withdraw GM foods as they have been insufficiently tested: http://www.psrast.org/psrlet.htm signed by 206 physicians/scientists.

  2. WILL GM CROPS BENEFIT FARMERS? Read up on the frequent poor physical and economic performance of GM crops: http://www.btinternet.com/~nlpwessex/Documents/gmagric.htm
    1. Lower yields from GM soya University of Wisconsin: www.btinternet.com/~nlpwessex/Documents/wisconsinRRsoyatrials98.htm
    2. Weed shift worries: http://www.biotech-info.net/weed_shift.html
    3. US farmers desert GM crops: www.guardianunlimited.co.uk/international/story/0,3604,230808,00.html
    4. No economic benefits for farmers from Bt maize, Univ. of Purdue: http://www.agcom.purdue.edu/AgCom/Pubs/ID/ID-219/ID-219.html

  3. GM crops will NOT solve world hunger say scientists: http://www.psrast.org/newgwohu.htm

  4. Deutsche Bank predicts GM food industry will collapse: http://www.natural-law.ca/genetic/NewsJuly-Aug99/GEN8-25DeutscheMonsanUSA.html

  5. The South African health authorities use "substantial equivalence" as a standard to determine the "safety" of GM foods. They ignore scientific opinion that this is "unscientific and arbitrary": http://www.psrast.org/fao96.htm

  6. The world renowned scientist who lost his job when he warned about GE foods. The Pusztai case: http://www.psrast.org/pusztai.htm

  7. THE SAFETY OF GE FOODS. Reasons To Expect Hazards And The Risk Of Their Appearance: Dr M Antoniou, et al. http://www.psrast.org/defknfood.htm

  8. The Worldwide Debate Over Genetically Modified Foods (Continent by Continent) + Effects on Business: http://www.Genetic-ID.com/debate/index.htm

  9. Serve Your Customers Safely and Effectively in the Non-GMO Market: http://www.Genetic-ID.com

  10. What you can do: Greenpeace http://www.truefoodnow.org/index.html?news

  11. Top US investigative journalists fired for exposing the link between genetically modified Bovine Growth Hormone (BST or rBGH) used on dairy herds and cancer in humans drinking "GM milk". Follow their court cases: www.foxBGHsuit.com For more information on "GM milk" banned in over 100 countries but licenced for sale in SA see:
    http://www.psrast.org/bghcanad.htm
    http://www.psrast.org/bghcpc.htm
    http://www.psrast.org/bghsalmonella.htm

  12. Lawsuit. The United States government deception on GM foods. (the government contradicted its own experts in approving GM foods & misrepresented facts in order to promote the US biotech industry): http://www.bio-integrity.org/FDADeception.html

  13. Genetically Manipulated Food News: http://home.intekom.com/tm_info

  14. Find out how to help eliminate poverty and feed humanity on pure organic food: hppt//:www.MaharishiOrganicAgriculture.com

  15. Childrens GM web site, covers the GM issues and is great fun: http://www.oneworld.org/penguin/genetics/home.html

  16. What leading scientists and public figures have said about the dangers of GM foods: http://www.btinternet.com/~nlpwessex/Documents/gmoquote.htm

  17. CALL FOR A FIVE YEAR FREEZE ON GENETIC ENGINEERING & PATENTING OF GENETIC RESOURCES IN FOOD & FARMING IN SOUTH AFRICA. To endorse the Freeze document contact SAFeAGE at Tel 021-761 0549 or e-mail safeage@mweb.co.za

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

WASTE OF TAXPAYERS MONEY.

Marketing organisations, backed by vested interests, promote GM foods and masquerade as being "science based". In the USA $ 50 million (R 350 million) is spent anually promoting GM technology to the uninformed and unsuspecting consumer. The South African public are being targeted in the same manner. Africa Bio has been launched to bring the "benefits" of GM foods & GM crops to the South African consumer. Africa Bio is a coalition of over 40 companies with vested financial interests in this controversial technology. SA Government departments using taxpayers money are also members of Africa Bio. Taxpayers money must be used on investigating safe and viable alternatives rather than on this dubious and potentially dangerous technology.

  1. At this very moment, there is 150% more food in the world than can be eaten (UN survey). Politics, poverty and inequitable distribution are what keep the hungry from accessing it.

  2. CHRISTIAN AID REPORT, MAY '99: Christian Aid's Indian research showed that land reform and simple irrigation can boost crops by 50%. (Do we need drought resistant crops? Maybe we should ask Dr Pusztai first? Monsanto's GM potatoes have been relegated to the dustbin.)

  3. Dr Tewolde Egzaibher of Ethiopia on GM crops: "We strongly object to the image of the poor and the hungry from our countries being used to push a technology that is neither safe, environmentally friendly nor economically beneficial to us." World Hunger Myths: http://www.natural-law.ca/genetic/NewsSept-Oct99/GEN9-10CdaWorldHungNewswee.html

  4. There has been no long term testing on GM foods. Australian food manufacturers, farmers and retailers are unlikely to get insurance liability cover on GM crops. The insurance industry there believe they contain risks similar to asbestos where 20-30 years down the track they will face huge claims.

  5. BAN ON GM CROPS PROPOSED: Dr Vandana Shiva, "endorsed the call for a five-year freeze (in South Africa) and said it was a "myth" that GM food would solve hunger problems of Africa and the Third World. There are too many lies being told in the name of science on this issue and a lack of honest, independent facts from independent agencies." The Mercury, 1 August, 2000 (South Africa).

WARNING !!!

"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector,"

THE LANCET, April 2000


Top PreviousNextFront Page
Date: Mon, 21 Aug 2000 11:14:32 +0200
From: ekogaia ekogaia@iafrica.com

Greetings all,

Here is yet another confirmation from the scientific establishment of what we are attempting to get into the impenetrable skulls of AfricaBio; that the present types of GE organisms and thier lack of regulation in the market and in nature is cause for concern and counter-productive. Please forward to any contacts that may be able to get the message through Neanderthal proportions of calcareous brain casing and imbedded into the inflexible putty of grey matter that seems to be genetically prevalent in certain members of the biotech industry.

All the best

Glenn.

The Promise of Biotechnology – the Threat of Genetically Modified Organisms.

By Patrick Brown, Professor, College of Agriculture & Environmental Science
University of California, Davis, CA 95616, July 2000

Sections:
Resistance and Trade disputes
Are the Current Generation of rDNA Crops, and the Regulatory System that approved them, Scientifically Defensible?
Is There Equivalence between rDNA and 'Traditional' Sexual Gene Transfer?
Do rDNA Techniques offer Greater Precision?
Do rDNA Techniques Provide an Acceptable Level of Risk?
Conclusion

Resistance and Trade disputes

Crop cultivars developed using recombinant-DNA technologies (rDNA crops) have been rapidly adopted by agricultural producers in the United States; and until recently, foods derived from these crops have been tacitly accepted by US consumers. In contrast, many European consumers have shown a marked resistance to these technologies, which, in turn, has resulted in the passage of trade restrictions and of laws that limit the import, growth or use of rDNA crops throughout much of Europe. The public uproar in Europe, and the protests surrounding the World Trade Organization meeting in Seattle, has now raised the awareness of many in the USA and given birth to a vocal and growing group of concerned consumers.

The intensity of the current debate has surprised many in the scientific community and has escalated into a highly polarized and increasingly antagonistic debate. Scientists, and the professional organizations that represent them, have been publicly supportive of this technology and often dismissive of public concerns. Most scientific comment suggests that 'education' is the key to gaining the needed acceptance, while almost no comment has recognized or addressed the fears of the public. Those who oppose rDNA technology interpret the apparent willingness of the US scientific community to embrace this new technology, while failing to adequately address the potential risks, as a betrayal of public trust.

Public uncertainty has resulted in the loss of markets, and will increasingly do so, for the current generation of rDNA crops and foods. Though this is clearly of substantial economic concern, by far the most significant consequence of public concern is the threat that this conflict poses for the entire field of plant biotechnology, which holds far greater promise of human benefit than that offered by any existing rDNA crop. The loss of this technology through careless and premature implementation would be truly devastating to the goal of developing more abundant and nutritious foods in an environmentally sensitive fashion.

This issue requires immediate and thoughtful attention from plant scientists. We must recognize that our knowledge of the processes that regulate gene incorporation and expression are in their infancy and that our capacity to manipulate the plant genome is crude. Given this current lack of understanding it is certainly possible that the current regulatory safeguards are inadequate and may not be offering sufficient protection against inadvertent creation of health and ecological problems.

Since the public education and research system is based upon a foundation of public trust, it is essential that we recognize and admit the unknowns associated with molecular biology and act with caution and integrity.

The following text describes some of the uncertainties associated with rDNA technology and illustrates how the scientific community's defence of the current generation of rDNA crops represents a substantial threat to the future of this promising new technology.

Are the Current Generation of rDNA Crops, and the Regulatory System that approved them, Scientifically Defensible?

In 1989 the National Research Council, following extensive scientific review, publicly concluded that crops derived from rDNA techniques do not differ substantially from those derived using traditional techniques. This conclusion forms the basis for current FDA policy that regulates the production and use of rDNA crops and foods. This conclusion is based upon the principle of "substantial equivalence" which states that the introduction of a gene of known and safe function into a crop of known characteristics is technologically neutral, hence the resulting crop can be presumed to be safe and is not subject to mandatory testing prior to release or use in foods. As this principle is central to the scientific and regulatory acceptance of this technology it deserves careful examination.

Is There Equivalence between rDNA and 'Traditional' Sexual Gene Transfer?

To adequately compare these technologies it is essential that each is well characterized and understood. The molecular processes that control gene incorporation and expression following a normal sexual crossing event, however, are only poorly understood and the extent of our ignorance is further revealed weekly as new processes involved in the regulation of gene expression in plants are determined. The inadequacy of our understanding is well illustrated by the host of genetic phenomena (such as co-suppression, intron-mediated enhancement, transcriptional regulation, protein-gene interactions etc) for which we have essentially no mechanistic understanding. Our knowledge of these processes is clearly in its infancy and few would claim that we understand more than a small percentage of the processes regulating sexual reproduction in plants.

Further, most of what is known of gene transfer using traditional and rDNA techniques illustrates the profound manner in which they differ. Traditional crossing involves the movement of clusters of functionally linked genes, primarily between homologous chromosomes, and including the relevant promoters, regulatory sequences and associated genes involved in the coordinated expression of the character of interest in the plant. The molecular regulation of this process and the biochemical and evolutionary significance of these controls is poorly understood.

In contrast to traditional techniques, current rDNA technologies (those used in all currently approved rDNA crops) involve the random insertion of genes in the absence of normal promoter sequences and associated regulatory genes. As there are very few examples of plant traits in which we have identified the associated regulatory genes, the introduction of a fully 'functional' gene using rDNA techniques is currently not possible. R-DNA techniques also involve the simultaneous insertion of viral promoters and selectable markers and facilitates the introduction of genes from incompatible species. These genetic transformations cannot occur using traditional approaches – which further illustrates the profound manner in which these processes differ.

Genetic material can be moved within and between species by the poorly understood processes of gene transposition. Though the occurrence of this phenomenon in traditionally bred plants is superficially equivalent to rDNA techniques (which involve the random insertion of "artificial transposons"), the mechanisms governing this process and the significance of transposition in traditional gene transfer are unknown. Given our profound lack of understanding of these processes it is impossible to compare sensibly the two processes. Indeed, it can be argued that gene transfer via rDNA techniques resembles the process of viral infection far more closely than it resembles traditional breeding.

In summary, it is clear that gene transfer using rDNA techniques is substantially different from the processes that govern gene transfer in traditional breeding. The extent to which these processes differ will become increasingly clear as we gain a better understanding of the processes governing gene movement, expression and regulation.

The presumption of "Substantial Equivalence" – the basis for current regulatory principles – is profoundly flawed and scientifically insupportable.

Do rDNA Techniques offer Greater Precision?

One of the much-touted benefits of r-DNA techniques is the capability to introduce only a discrete and well-defined number of genes into the new cultivar whereas a traditional crossing event introduces thousands of genes. This ability to control the types and numbers of genes introduced speeds the introduction of a gene of interest by eliminating the need for extensive backcrossing to the elite parent. Many have suggested that this approach is fundamentally more "precise" than traditional breeding techniques and have argued that the technique is consequently "safer".

The ability to introduce a precisely defined compliment of genes using rDNA techniques, however, is not equivalent to the introduction of a precisely defined and biologically integrated character. Whereas the incorporation of a new character using traditional techniques occurs in a fully functional and appropriately regulated manner, rDNA gene introduction is more or less random, and does not involve introduction of the regulatory sequences normally associated with that gene. Traditional techniques, therefore, result in greater "biological precision" than random gene insertion using rDNA techniques.

The FDA policy statement further suggests that it is highly unlikely that rDNA techniques will result in the inadvertent production of allergens or toxic compounds and that once incorporated into the genome, the introduced gene functions like all other genes in the genome. These statements are offered in support of the premise that rDNA experiments are more predictable than traditional breeding approaches. This presumption is, however, clearly contradicted by a large volume of scientific literature and experimental experience that illustrates the propensity of rDNA techniques to produce unexpected and often lethal perturbations. Indeed metabolic and phenological perturbations are very frequently observed following transformation events and a high percentage of transformants show profound growth aberrations. Indeed the propensity of random gene introduction to cause metabolic disruption is well documented and actively used to probe gene function.

While extreme aberrations can be easily selected out, it is also highly likely that undetected biochemical perturbations remain following essentially all transformation events. Since it is not standard practice to screen transformants there is clearly a potential for biochemically abnormal transgenic plants to persist. This is further exacerbated through the use of tissue culture and embryo rescue etc. which can be used to "rescue" metabolically altered transgenic plants that might otherwise have been eliminated during early plant growth. Whether or not these same perturbations occur following traditional breeding is unknown. Lack of knowledge, however, is not proof of safety.

The metabolic perturbations caused by rDNA gene introduction may result in production of toxic compounds. Many plant species have the capacity to produce toxic compounds which, under natural conditions, serve to protect against animal and insect predation as well as contributing to disease resistance mechanisms. In certain species, such as those in the Solanum family, there are many well- characterized and highly unpalatable or toxic compounds. It is very likely that the majority of the genes involved in the formation of these toxic and unpalatable compounds are still present (though not expressed) in modern tomato and potato. Given the random nature of rDNA gene insertion, and the use of a promiscuous viral promoter sequence, the potential clearly exists that tomato could be induced to produce a toxin as a result of an rDNA gene transfer. Whether this would occur with the same frequency following traditional sexual breeding is unknown. The presumption that it cannot occur is clearly invalid.

Clearly the assumption that a transformed crop is exactly the sum of the original crop and the introduced gene is not acceptable. RDNA techniques are profoundly different from traditional breeding methods and are well known to cause unexpected metabolic perturbations. The principle of substantial equivalence is not scientifically justifiable; hence we can make no a priori assumption of the safety of any rDNA manipulation.

Do rDNA Techniques Provide an Acceptable Level of Risk?

The preceding discussion clearly demonstrates that the risks associated with rDNA technology cannot be determined given current understanding of gene expression. Nevertheless it has been argued that risk is a normal part of technological advancement and that acceptance of this risk is warranted in the instance of rDNA crops.

While it is true that we accept risks as a normal part of life, most of the risks we accept are defined by experience and are understood before they are taken. Some risks are also taken because the rewards are perceived to outweigh the risks. Traditional breeding has on the whole been an acceptable risk with 10,000 years of experience, and a trust in the motives of those producing the new cultivars.

Many, however, are not yet prepared to accept the risks of rDNA technologies. This is in part due to a lack of understanding of the risks, the minimal benefit of the current crop of GMOs, and a mistrust of the motives of those selling the technology. Given the current state of our knowledge of this technology and the nature of the GMOs currently available, this lack of public trust is entirely reasonable. Public acceptance will require convincing demonstration of safety and the development of crops with a more direct benefit to the consumers.

The concerns expressed by many are further validated by the current generation of GMOs that have been incorporated into the food system without adequate public consultation and scientific scrutiny. The current generation of GMO crops do not provide any tangible public benefit, have not contributed to reduced food costs, and have no confirmed ecological benefit. This is well illustrated by the two most prevalent types of GMOs in use in the US.

Insect-resistant crops containing the gene encoding the Bacillus thuringiensis toxin have been planted widely in the US. This transgenic technique promises to reduce the use of pesticides and reduce growers' costs. While reduction in pesticide use is an admirable goal there are significant grounds to question the appropriateness of the current generation of Bt-producing crops and to question the haste with which these crops were released for widespread use.

The current generation of Bt crops utilize a single Bt gene rather than the complex of Bt genes that are available. There is widespread agreement amongst scientists that this use of a single Bt gene will increase the speed with which pest resistance will develop. To help alleviate the development of insect resistance the USDA and Monsanto now advise growers to plant refuge areas to ensure non-resistant insects persist under the premise that this will reduce the rate of resistance development. While this is theoretically sound there is insufficient ecological data to determine optimal size of these refuges or to estimate how effective they will be.

The current generation of Bt crops also utilize antibiotic resistance as the selectable marker and rely upon viral promoters to ensure high degrees of expression. This clearly introduces a risk associated with a promoter designed to be free of regulatory controls, it excites those who see viral and antibiotic-resistance genes as threatening, and it ensures that the Bt protein is distributed uniformly throughout the plant. The uniform presence of the Bt protein enhances the likelihood of resistance development and ensures that the protein is present throughout plant development and is present in the pollen. The death of Monarch larvae was a direct consequence of the presence of active Bt toxin in the pollen.

While some have questioned the scientific relevance of this study it did illustrate the inherent flaws in this cultivar, methods exist (or will soon exist) that make the use of viral promoters and antibiotic resistance markers unnecessary. There is no justification for the expression of Bt in the pollen, and the release of cultivars with a single Bt gene is certain to hasten resistance development. In the absence of data to support the refugia concept there is very little to prevent the development of widespread insect tolerance of Bt.

Clearly the release of the first generation of Bt-containing crops was premature and based upon flawed scientific principles. Regulatory and scientific support for this cultivar is clearly questionable.

The other dominant type of GMO in use today is the Roundup-Ready varieties of cotton, soybean and corn. Not only do these cultivars contain many of the same questionable genes as those in Bt crops, but also they have the additional propensity to contribute to the development of herbicide-resistant weed species for which the consequences are poorly understood. Roundup-Ready crops are also of questionable ecological value and build a long-term dependence on the use of the herbicide Glyphosate.

Not insignificantly, the overtly 'corporate' nature of these crops and the dependence they build on high cost and ecologically questionable technologies has resulted in widespread suspicion of the motives of those promoting these cultivars.

It is abundantly clear that the current generation of GMOs were developed using an untested and unsophisticated technology and were released prematurely to ensure early returns on corporate investment. Clearly this does not represent a sound justification for the release and widespread use of these crops.

Perhaps one of the most profoundly flawed justifications of GMOs is illustrated in the often-cited refrain "GMO foods have been widely available in the marketplace for the past 5 years and not one incident of harm to public health has been documented". Since every introduced gene is inserted into a different genetic location, and every gene differs in functions and interactions within the genome, and as every species can be expected to 'react' differently to the gene introduction process, it is clear that the safety of one GMO is in no way predictive of the safety of another. In many respects the claim of safety by association is no more valid than the claim that the safety of aspirin predicts the safety of all future drugs.

Conclusion

The real threat to the future of plant biotechnology is the irresponsible and premature releases of the first generation of GMOs that are full of unsound scientific assumptions, rife with careless science, and arrogantly dismissive of valid concerns. The current generation of GMOs provide little real benefit except corporate profit and marginally improved grower returns, while at the same time introducing a host of poorly studied human and ecological risks. Not surprisingly, many have questioned the value of these crops and the integrity of those who support their use.

Given these issues and the overall lack of knowledge of rDNA technology it can only be concluded that the current FDA regulations guiding the release and testing of GMOs is inadequate. It can further be concluded that the technology is inadequately developed to ensure its safety. In the absence of a sound scientific basis to predict the full consequences of rDNA crop development, we must either subject all new crops to a rigorous testing program that considers all potential health, social and environmental concerns or halt further release of rDNA crops until a firm scientific understanding of the biological principles is attained.

As scientists it is our responsibility to recognize that we do not yet have sufficient knowledge of the process to use it safely. We must work towards addressing all of the concerns explicit in the current generation of crops, and must support a rigorous testing program to ensure the safety of all GMO foodstuffs in the interim. To date many in the scientific community have been unwilling to rationally consider the concerns surrounding the current GMOs and have wrongly considered that a defence of GMOs is a prerequisite to protect the science of plant biotechnology. Nothing could be further from the truth or more threatening to the future of this technology.

*****

"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector,"

THE LANCET, April 2000

"When a butterfly flaps its wings in Africa, it can cause a hurricane in New York."


Top PreviousNextFront Page
Date: Mon, 21 Aug 2000 06:38:37 EDT
From: RBBAX@aol.com
Posted: 08/20/2000 By ekogaia@iafrica.com
Originated: Biotech Activists biotech_activists@iatp.org

An excellent summary of arguably the biggest mistake that mankind has made so far.

R.

Donella H. Meadows is an adjunct professor of environmental studies at Dartmouth College. More about Donella Meadows. Her column appears each Friday in Tidepool at http://www.tidepool.org/home.html

"Next time you hear a scientist asserting that gene splicing is safe, remind yourself that there is no scientific evidence for that statement. We are profoundly ignorant about what we are doing to the code that generates all life. And unfortunately some scientists, including those entrusted with public safety, are willing to lie".

Donella H. Meadows, adjunct professor of environmental studies.

How it Happened that we don't regulate Biotech.

by Donella Meadows [posted.8.18.00] http://www.tidepool.org/home.html

Sections:
Suddenly the Concern disappeared
Why? How? When?
Fudging the Test

Suddenly the Concern disappeared

Back in the 1970s the awesome news that scientists had learned how to redesign genes started a regulatory flurry. Distinguished panels met to ask imponderable questions. Could some human-created form of life carry self-multiplying havoc into the world? How can we prevent such a disaster?

Back then genetic escapes were considered so likely that gene-splicing research was carried out in sealed labs. The citizens of Cambridge, Massachusetts, home of Harvard and MIT, forbade such labs within their city limits. Congress debated dozens of bills to regulate genetic engineering.

Then, suddenly, the concern disappeared. Genetic engineering became routine in academia and a hot field of competition in business. Nowadays scientists and corporations create gene-spliced organisms and release them into nature with astounding little oversight.

I always wondered how that happened. It's not as if the serious questions about "genetic pollution" were ever answered. Our ignorance of the health and ecological and evolutionary impacts of gene-spliced crops and other products is still enormous. But somehow the biotech enterprise got a social and regulatory green light. No questions asked. Full speed ahead.

Why? How? When?

A partial answer to that question has appeared in the July issue of "Gene Watch," the bulletin of the Council for Responsible Genetics. Susan Wright, a science historian at the University of Michigan, writes about an MIT archive in which she found the transcript of a fateful meeting that took place in 1976 at the National Institutes of Health.

Then, as now, the greatest area of concern was microbes. Higher organisms carry their DNA around in discrete packages inside cell nuclei. They release genes into the world only under relatively controlled acts of reproduction. Bacteria and viruses, on the other hand, slosh genes around in a shockingly messy way.

They pick them up and drop them off, shuffle them, trade them, insert them into the supposedly organized genomes of higher forms of life. That's how viruses infect us. It's also one of the ways geneticists paste genes from one kind of critter into another. First they insert a snipped-out gene, from a flounder, say, into a virus or bacterium. Then they use the microbe to smuggle the flounder gene into, say, a salmon or a tomato.

The problem is that once the gene has been loosened from the organized flounder into the disorganized microbial world, there's no telling where it might end up. One single-celled creature could pass it to another. For all we know, it could end up in a minnow or a whale or in our own guts.

Fudging the Test

In 1976 an august committee of NIH virologists was asked to test this danger. They were to snip out from a virus a gene that causes tumors when the virus infects mice. They were to paste that gene into bacteria and then see whether the bacteria could cause tumors in other animals. If so, it would not only be evidence that some kinds of gene-splicing might turn cancer into a communicable disease, it would also be evidence that genes unleashed into microbes could spread beyond anyone's recall.

The committee debated what kind of bacteria to use in the test. Scientifically the answer was obvious; you seek out the worst case. You use bacteria likely to thrive and infect the test animals. But the virologists had more than science in mind. They worried about politics, about public controversy, about their own work being regulated. So they chose to use weakened bacteria that were unlikely to do harm.

In short, they fudged the test. Here are some of the things they said, recorded in the transcript of the meeting. "By using known pathogens, it seems to me we go politically in the wrong direction even though scientifically it does make more sense." "If we want to get these experiments done so we can go about our work quickly, maybe one shouldn't introduce problems of this level." "It's molecular politics, not molecular biology, and I think we have to consider both, because a lot of science is at stake."

They wanted "a slick New York Times kind of experiment." But even the weakened bacteria they ended up using did infect some test animals with tumors. That result, says Wright, "had the NIH campus buzzing at the time."

So they fudged again. The disturbing results were never published in a major journal. To the contrary, a 1979 NIH press conference announced that "this form of research is perfectly safe." The New York Times reported that "the risks are considerably less than had been feared." All through the 1980s and 90s, this study was cited as evidence that bioengineering poses no threats. Only in 1988, at a meeting of federal regulators, did one of them honestly articulate our government's actual policy: "If the American public wants progress, they will have to be guinea pigs."

******** – ends – ********

"All policymakers must be vigilant to the possibility of research data being manipulated by corporate bodies and of scientific colleagues being seduced by the material charms of industry. Trust is no defence against an aggressively deceptive corporate sector,"

THE LANCET, April 2000

"If you look at the simple principle of genetic modification it spells ecological disaster. There are no ways of quantifying the risks......The solution is simply to ban the use of genetic modification in food."

Dr Harash Narang, microbiologist and senior research associate at the University of Leeds, who originally caused a scientific and political storm by claiming a link between mad cow disease and CJD in humans.


Top PreviousNextFront Page
Date: Mon, 21 Aug 2000 12:56:55 +0200
From: ekogaia ekogaia@iafrica.com

BIOWATCH: Scientists cautioned about genetically modified food

By MICHAEL LITTLEJOHNS, Earth Times News Service, FAO

UNITED NATIONS – The Food and Agriculture Organization has again stressed its concerns in the international debate over the genetic modification of food sources, warning scientists of their "moral responsibility" to supply objective, peer-reviewed data and not rush to give publicity to "immature, insufficiently tested results." In short, avoid any temptation to whitewash.

But at the same time Louise Fresco, the agency's deputy head, also underscored its view that every means must be employed to improve food security – "subject to careful assessments being made."

She went on to remind the scientific community of their moral responsibility to speak up for the poor and hungry of the world, and the "small countries, small companies and small farmers [who] have very small voices" where the globalized economy is concerned.

Fresco, an assistant director general of FAO, said scientists were especially important because they best understood the likely consequences of keeping silent about the problems facing the impoverished masses. In a wide ranging inaugural address to the 3rd International Crop Science Congress, in Hamburg, she spoke of the uneven distribution of food, the responsible use of land and water and harnessing biological diversity, as well as the hot potato of genetic modification, a subject of lively debate in Europe and the US.

"Popular perception has it that the world of agricultural science has isolated itself from the man in the street, or the woman in the field, and is seeking to impose its ideas on the planet, rather than understand public needs," she said. "These views are not new, but they have quickly become more vigorous.

"The most forceful public questions are being asked about both the sharing of benefits and the perceived negative effects on human health and the earth's environment of the uncontrolled application of genetically modified crops. FAO's position is that we must use every means at our disposal to improve food security subject to careful assessments being made."

The agency was confident that a consensus could be reached on GM food standards, she said, while cautioning against a rush to judgment – an implicit warning to scientists working for corporations with a vested interest in playing down the risks in GM.

She noted that FAO recently set up an international ethics committee to include the advice of philosophers and religionists in an investigation of the human factors related to agriculture so that strategies might be developed to use genetic modification as a tool against hunger and malnutrition, while still taking all necessary precautions to protect health and the environment.

In her remarks, Fresco joined a rising chorus of senior officials in the UN community who still have serious reservations about the virtue of globalization. "Whatever its potential benefits, globalization also exacerbates the existing differences among countries and regions and calls for specific strategies to be developed according to different needs," she said.


Top PreviousFront Page
Date: Mon, 21 Aug 2000 22:22:06 +0200
From: ekogaia ekogaia@iafrica.com

This just in; Fact or fiction? believe it or not?

http://www.ananova.com hardly a scientific website but go figure out yourself

'Frankengrass' creates multi-coloured lawns

www.ananova.com

The traditional green colour of the lawn could become a thing of the past as scientists develop lawns in different colours and even lawns that light up at night. (just what we always needed and were afraid to ask for)

The new grasses will also kill pests by producing a designer toxin that uses a gene taken from a poisonous fungus. (Bt; wow, revolutionary, amazing and very very stupid)

The new range of genetically-modified lawns have been called "Frankengrass" by environmentalists who are warning the grass could cross-breed with other species.(you bet)

But garden products company Scotts believe their work will revolutionise gardens, golf courses and golf pitches.(No Blade of Grass; anybody remember the movie?)

Chief executive Charles Berger said: "In the next five years lawns will need less fertiliser, water and mowing - and pest insects won't come near."(It wont be called the green, it will be called the gravel)

The company is already researching the grasses after buying the gardening arm of GM crop producer Monsanto, The Sunday Times reports. (now how did I guess that?)

Around 40 test sites in the US have been vandalised by an anarchist organisation. (is that surprising? Is this story a put up? who knows? the terrifying thing is that it probably is for real folks!)