Genetically
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26 January 2000

Table of Contents

Secret deal will bring a flood of GM to Britain
Why the West must swallow gene foods
Nueremberg Code On Human Experiments
Yellow Rice and Beta Carotene
Why is Monsanto being sued for $71 Million?
New book "Stolen Harvest" by Vandana Shiva
FDA Botches Public Record of Opinion Statements
Death exposes risks of gene therapy
New Study Finds Organic Is Healthier
Govt leaders respond to Maharishi's plans
Brit. Patent on Clone Human Cells Raise Concerns
GM mucous-corn

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Date: 23 Jan 2000 05:43:36 U
From: jim@niall7.demon.co.uk
From: wytze geno@zap.a2000.nl
From List: Biotech Activists biotech_activists@iatp.org
Posted by: l.dumble@hps.unimelb.edu.au

Secret deal will bring a flood of GM to Britain

Biotech Activists wrote:

By Jonathon Carr-Brown, Jo Dillon and Geoffrey Lean THE SUNDAY INDEPENDENT, London, 23 January 2000 http://www.independent.co.uk/news/UK/Environment/2000-01/gmdeal230100.shtml

Leading European Union officials are trying to broker a secret deal which could result in Britain being flooded with imported GM foods. Pascal Lamy, the Trade Commissioner, is determined to pursue the deal with the United States, despite being explicitly forbidden to do so by ministers of his member states, including Michael Meacher, Britain's environment minister.

A spokesman for Mr Lamy confirmed that he was keen to get the deal "on the agenda". If he succeeds, Britain and other European countries could lose their power to block imports of GM foods and seeds from the US, which is aggressively pushing them.

In return, The Independent on Sunday has learnt, White House officials have promised to drop a US campaign to force cuts in the subsidies paid to European farmers under the Common Agricultural Policy (CAP). That would be particularly important to France, Mr Lamy's own country. But it will be regarded as a double betrayal by environmentalists and by the British government which has been pressing for reform of the CAP, blamed for doing much to destroy wildlife and the countryside by promoting intensive agriculture.

The revelation of Mr Lamy's intentions is bound to create a row at international negotiations on the GM trade which open, under the auspices of the United Nations, in Montreal tomorrow. The talks are likely to be scuppered by the US's insistence that any agreement under a proposed UN Biosafety Protocol would be subordinate to a future WTO deal. Similar talks took place last year when the US and five other grain exporting countries, called the Miami group, blocked agreement by 160 nations on controls which would have allowed governments to refuse to import GM foods and seeds.

The Miami group, which includes Canada, Australia, Argentina, Uruguay and Chile, want all grains and other foodstuffs (90 per cent of GM food) excluded from any biosafety agreement. A confidential US State Department memorandum, obtained by The Independent on Sunday, also reveals that America has been putting unrelenting pressure on European governments to accept American GM products. It says that US corn exporters alone "stand to lose $220m in sales" because of European delays in approving GM crops and says that the Clinton administration will need to keep up the pressure "to find a way to speed approvals".

Mr Lamy first proposed the deal at the turbulent World Trade Organisation (WTO) conference in Seattle last month. He accepted US demands effectively to transfer discussions of controls on the GM trade from the United Nations negotiations where it was heavily outnumbered to the WTO, which would take a much more permissive attitude. In return the US agreed to drop plans to ensure that the WTO forced reform on the CAP, which it regards as competing unfairly with US agriculture.

His move was immediately rejected by EU trade, food and environment ministers at the conference. Mr Lamy backed down, but only after reminding the politicians that the commission, which he represented, was responsible for trade negotiations. His spokesman said: "This type of deal does not necessarily mean that we are going to open up markets to American GM foods." But his plans are still bound to run into intense opposition from ministers.

Mr Meacher said yesterday: "Unfortunately, and without authority, the commissioner made a serious mistake in Seattle. He was comprehensively repudiated by ministers. There can be no question of trying to resuscitate the proposal."

Tony Juniper, Policy Director of Friends of the Earth said: "It is an absolute scandal that an unelected bureaucrat is taking it upon himself to make up policy as he goes along, directly against the wishes of governments who are seeking to protect their consumers and the environment."


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Date: 23 Jan 2000 06:11:23 U
From: jim@niall7.demon.co.uk

Why the West must swallow gene foods

By Robin McKie, Sunday January 23, 2000

http://www.newsunlimited.co.uk/gmdebate/Story/0,2763,125822,00.html

They're boycotted by British shoppers, and this week an international conference will decide if trade in GM organisms should be controlled. But many scientists believe they are the solution to starvation in the Third World, reports Robin McKie
GM food: special report

Consider the tomato - so much a part of everyday life that we hardly notice it. Yet it has a murky past, and it is one that scientists should note carefully.

In the nineteenth century, the tomato was known as the wolf's peach, and Europeans and Americans believed it was deadly poisonous. In 1820, New York forbade its consumption and only relented when Colonel Robert Johnston announced that he would eat an entire bag of them outside the courthouse in Salem, New Jersey. Two thousand people turned up to watch him die, while a band played a funeral march. But Johnston ate the lot and announced: 'This luscious, scarlet apple will form the foundation of a great garden industry.'

For such prescience, Johnson deserves canonisation as the patron saint of hothouses, though his story has far more than historical importance, for it shows there is nothing new in misplaced hysteria about food.

As David Aaron, US Under-Secretary for Commerce, warned a conference on 'Biotechnology: The Science and the Impact' in The Hague last week: 'Last century it was the tomato, this time it is biotech food.'

But there is a crucial difference today. We no longer have the time to indulge in fantasies and misconceptions about food, and in particular about gene foods. One billion people - more than the combined population of the United States and Europe - now survive on $1 or less a day, and are starving.

The UN has pledged to halve that number by 2015, a startlingly ambitious goal - for it means farmers will have to match mankind's entire food production of the past 10,000 years in the next one and a half decades.

There is only one way to achieve this dramatic goal, experts warned delegates, and that is by exploiting biotechnology, the science of manipulating the genes of living organisms.

However, this route is now being seriously hindered by Western consumers who, with increasing vehemence, are rejecting biotechnological products, mainly GM foods, and blocking their testing and funding.

These are the killer tomatoes of today, they claim. 'Unfortunately, consumers think products like genetically modified foods pose risks and offer no benefits,' said Sir Robert May, the Cabinet's chief scientific adviser. 'It is the attitude of a privileged élite who think there will be no problem feeding tomorrow's growing population.'

Such prejudices form the background for this week's international talks in Montreal when nations will discuss imposing limits on the safe handling, transfer and use of genetically modified organisms that could have an adverse effect on the environment. At issue is the fear that the US and its partners are trying to monopolise trade in GM crops, a bid that has made many other countries, includ ing Third World nations, suspicious of such products.

The irony is that without biotechnology, there will be no salvation for developing nations, delegates heard. To save 500 million people from starvation, they will have to increase meat production by an estimated 114 per cent, and milk output by 133 per cent.

For mighty conglomerates, that would be a tall order. For poor smallholders, the main providers of Third World crops, it would be impossible without the geneticist.

The aim is to develop techniques best suited to the Third World, ideas that include modifying crops so that their stems, used as animal feed in developing nations, are more nutritious, thus boosting livestock quality, or adding genes that will improve the vitamin content of maize or rice.

A perfect example of this type of technology was provided by Tony Irvin, of the International Livestock Research Institute, who has discovered a breed of sheep called the Red Masai, herded by East African nomads.

'These animals have developed a unique resistance to parasitic worms,' he said. Such parasites take a terrible toll of sheep in farms throughout the world, and Irvin and his colleagues believe they can develop techniques to transfer resistance to other breeds.

But this raises other headaches. How can politicians ensure the Masai people will benefit? Will they not suffer the fate of other indigenous peoples whose products have been pilfered and exploited without financial return?

Consider another fruit: the Chinese gooseberry, grown for centuries by Chinese farmers. Then a group of wily New Zealanders adopted, marketed and renamed it: the Kiwi fruit. They made a fortune. Chinese farmers got nothing.

There are scores of other examples, with developing countries accusing Western corporations of trying to patent the genetic codes of dozens of their native plants, including basmati rice, turmeric, black pepper, cotton - even the 'sacred' neem tree.

And such cases worried Irvin, as well as the World Bank vice-president Ismail Serageldin. 'We have got to make sure this does not happen with the Red Masai,' said Serageldin. 'Perhaps we will have to license the gene and use the proceeds to set up a trust fund for the Masai. Whatever else, we have a moral obligation to these people.

'Essentially, we are seeing a scientific apartheid being established between the Northern and Southern nations. It is not the science that divides them but the intellectual property rights that underpin products. We have got to find ways to make these available - perhaps by shortening the lifetime of patents from 17 to five years, or only asking for low, flat fees for access to technologies.

But there were encouraging signs, the delegates heard. Pharmaceutical giant Merck recently gave away its river blindness drug to the Third World, as did Novartis with its leprosy medicine.

Far more important for the question of feeding the world, however, has been the development of 'golden rice', a genetically modified strain that can impart doses of vitamin A, which standard rice lacks. 'Four hundred million people suffer from serious vitamin A deficiency, of whom one million die every year,' geneticist Chris Somerville of Stanford University told delegates. 'However by using genes from the daffodil, we have created rice that is not only yellow, but contains vitamin A. That crop was created with Rockefeller Foundation cash and will be distributed throughout the Third World in the next couple of years.'

But Somerville added that it took 12 years to develop golden rice. In that time, the world's population increased by another billion to its current six billion.

'In other words, if we want to make breakthroughs we are going to have to develop a lot more products like golden rice and do it a lot more quickly than we are doing at present.'

Yet the West, and in particular Europe, is now dragging its heels more and more in the face of intense customer hos tility to genetically modified foods, the continent's killer tomatoes.

'I think Europeans are going to have to carry a very heavy moral burden over their attitude to biotechnology,' Somerville added.

In the end, what is needed is a glamorous GM product that would change the image of biotechnology, May concluded. 'We need a GM apple that will make you thin and wicked. I suspect that would do the trick.'


Top PreviousNextFront Page

Date: 23 Jan 2000 08:29:16 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Nueremberg Code On Human Experiments

By Prof. J.E. Cummins

Thought I would provide the code on human experiments. GM foods that are not labelled clearly violate the code and provide results that are not scientific because the results of the experiments are hidden by failure to label.

Even gene therapy seem to ignore the code in USA. Such matters should be considered by the United Nations:

THE NUREMBERG CODE

[from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946 - April 1949. Washington D.C.: U.S. G.P.O, 1949-1953.]

Permissible Medical Experiments

The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts:

  1. The voluntary consent of the human subject is absolutely essential.

    This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

    The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity.

  2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

  3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

  4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

  5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

  6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

  7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

  8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

  9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

  10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Of the ten principles which have been enumerated our judicial concern, of course, is with those requirements which are purely legal in nature –r which at least are so clearly related to matters legal that they assist us in determining criminal culpability and punishment. To go beyond that point would lead us into a field that would be beyond our sphere of competence. However, the point need not be labored. We find from the evidence that in the medical experiments which have been proved, these ten principles were much more frequently honored in their breach than in their observance.

Many of the concentration camp inmates who were the victims of these atrocities were citizens of countries other than the German Reich. They were non-German nationals, including Jews and "asocial persons", both prisoners of war and civilians, who had been imprisoned and forced to submit to these tortures and barbarities without so much as a semblance of trial. In every single instance appearing in the record, subjects were used who did not consent to the experiments; indeed, as to some of the experiments, it is not even contended by the defendants that the subjects occupied the status of volunteers.

In no case was the experimental subject at liberty of his own free choice to withdraw from any experiment. In many cases experiments were performed by unqualified persons; were conducted at random for no adequate scientific reason, and under revolting physical conditions. All of the experiments were conducted with unnecessary suffering and injury and but very little, if any, precautions were taken to protect or safeguard the human subjects from the possibilities of injury, disability, or death. In every one of the experiments the subjects experienced extreme pain or torture, and in most of them they suffered permanent injury, mutilation, or death, either as a direct result of the experiments or because of lack of adequate follow-up care.

Obviously all of these experiments involving brutalities, tortures, disabling injury, and death were performed in complete disregard of international conventions, the laws and customs of war, the general principles of criminal law as derived from the criminal laws of all civilized nations, and Control Council Law No. 10. Manifestly human experiments under such conditions are contrary to "the principles of the law of nations as they result from the usages established among civilized peoples, from the laws of humanity, and from the dictates of public conscience."

Whether any of the defendants in the dock are guilty of these atrocities is, of course, another question.

Under the Anglo-Saxon system of jurisprudence every defendant in a criminal case is presumed to be innocent of an offense charged until the prosecution, by competent, credible proof, has shown his guilt to the exclusion of every reasonable doubt. And this presumption abides with the defendant through each stage of his trial until such degree of proof has been adduced. A "reasonable doubt" as the name implies is one conformable to reason – a doubt which a reasonable man would entertain. Stated differently, it is that state of a case which, after a full and complete comparison and consideration of all the evidence, would leave an unbiased, unprejudiced, reflective person, charged with the responsibility for decision, in the state of mind that he could not say that he felt an abiding conviction amounting to a moral certainty of the truth of the charge.

If any of the defendants are to be found guilty under counts two or three of the indictment it must be because the evidence has shown beyond a reasonable doubt that such defendant, without regard to nationality or the capacity in which he acted, participated as a principal in, accessory to, ordered, abetted, took a consenting part in, or was connected with plans or enterprises involving the commission of at least some of the medical experiments and other atrocities which are the subject matter of these counts. Under no other circumstances may he be convicted.

Before examining the evidence to which we must look in order to determine individual culpability, a brief statement concerning some of the official agencies of the German Government and Nazi Party which will be referred to in this judgment seems desirable.


Top PreviousNextFront Page

Date: 23 Jan 2000 14:11:13 U
From: "j.e. cummins" jcummins@julian.uwo.ca

Yellow Rice and Beta Carotene

By Pro. Joe Cummins, e-mail: jcummins@julian.uwo.ca, 23 January 2000

Recently the development of yellow rice, enriched in the vitamin A precursor B-carotene was reported and used to promote the idea that biotechnology is humane and devoted to betterment of the poor of the world. Vitamin A deficiency in children is a severe problem in the equatorial countries.

However, the publicity about the crops enriched in vitamin A shows the tunnel vision of the advocates of biotechnology in their apparent unwillingness to consider all of the evidence. Vitamin A taken as a dietary supplement in areas where green and yellow vegetables are a normal part of the diet are a cause of birth defects in humans, about 1 infant in 57 had malformations attributed to the supplement (Rothman etal 1995).

However, it has been pointed out that the rice are enriched in the precursor, B-carotene of Vitamin A and B-carotene has limited absorption from the intestine. However, dietary intake of yellow-green vegetables, liver and laver (purple kelp) produced vitamin A poisoning in a Japanese woman dieting on pumpkin then later liver and laver, her blood levels of B-carotene returned to normal after adjustment of her diet (Nagai et al 1999). The point here is that vitamin A poisoning can be caused by excess B-carotene intake. Ethanol alcohol intake was found to enhance the liver toxicity and carcinogenicity of B-carotene. Moreover, in smokers who also consume alcohol , B-carotene promotes pulmonary cancer and possibly cardiovascular complications (Leo and Lieber 1999).

In conclusion, the gifts of genetic engineering may come with untoward consequences. The adverse impacts of GM crops should be reported full and truthfully by those promoting its benefits.

References

  1. Leo,M., and Lieber,C. Alcohol, vitamin A and beta-carotene : adverse effects, including hepatotoxicity and carcinogenicity Am J Clin Nutr 69, 1071-85,1999

  2. Nagai,K.,Hosaka,H.,Kubo,S.,Nakabayashi,T., Amagasaki, Y. and Nakamura, N. Vitamin A toxicity secondary to excessive intake of yellow-green vegetables, liver and laver J. Hepatol 31,142-8,1999

  3. Rothman,K.,Moore,L.,Singer,M.,Nguyen,U., Mannino,S.,Milunsky,A. Teratogenicity of high vitamin A intake N Engl J Med 333,1369-73,1995

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Date: 23 Jan 2000 16:37:04 U
From: Judy_Kew@greenbuilder.com (Judy Kew)

Why is Monsanto being sued for $71 Million?

By Betty Martini, Mission Possible International 770 242-2599

After the deal for American home Products merger fell through in October 1998 Monsanto put their NutraSweet Co. subsidiary on the block. There are no takers. NSC Technologies Co. makes phenylalanine which is 50% of NutraSweet, so Monsanto sold that business last April to Great Lakes Chemical Corp. for $125,000.000.

January 20, Great Lakes filed in the US District Court in Deleware for $71 million in damages, asserting that Monsanto exaggerated NSC sales, and projected $68.2 million a month before the deal closed. This was twice the $33 million they actually realized in l999. Great Lakes says Monsanto concealed other material facts, pending litigation and worldwide price cuts because of a marked shift to other sweeteners.

Monsanto visited http://www.dorway.com 117 times in two weeks alone in December, l998 which exposes aspartame as a deadly neurotoxin, and are often on the web site. They knew the sale of aspartame was only going down. At the time they were making this deal with Great Lakes it was at the height of the Nancy Markle post making world news on aspartame's dangers.

I wrote the original post to a neurological list after lecturing for the World Environmental Conference which was funded by grant to Elizabeth State University in l995.

Dr. Clarice Gaylord of the EPA, keynote speaker, said: "We have an epidemic of MS and lupus and we can't identify the toxin." I responded, "I'm Betty Martini from Mission Possible and here to lecture on MS and lupus and identify the toxin as NutraSweet".

In late November or early December, l998 a Nancy Markle published the post about the World Environmental Conference under her name, changing the title and altering it somewhat. Shoshanna Allison, a global networker, put the post on 450 global networks because her ex-husband had been a heavy user of aspartame and developed lupus, mood swings, weight gain and other NutraSweet problems, and she wanted others to be warned.

No one has been able to trace Nancy Markle but today there is a web page with physician confirmation of the dangers of aspartame exposed in the post on http://www.dorway.com/nomarkle.html To make sure those searching for Markle find the real author, true facts and congressional records there is now a http://www.nancymarkle.com domain.

This post has been a center of attention and world news for over a year because as victims read their symptoms and abstain medical problems are disappearing. So more copies are made to warn others, and the phone never stops ringing with the horror stories of aspartame nightmares. Two support groups have been set up on line for the victims and Dr. H. J. Roberts has declared Aspartame Disease a world epidemic. His 6 page report on aspartame addiction is cover story in the Townsend Letter For Doctors this month and a copy has been sent to the Justice Department to advise that this deadly, addictive drug is being consumed by even infants and children in their food and medications. What a crime.

Monsanto's tactic to kill the truth is to fund the American Dietetics Assoc., the American Diabetes Assoc., and other trade organizations and feed false information to the media about "The most tested product in history". This propaganda which is also sent out by the FDA in the IFIC brochure is rebutted on http://www.dorway.com with medical references. Monsanto uses its advertising, public relations and political pull in a desperate effort to keep the boat afloat. But it looks like a $71 million chunk will break off soon!


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Date: 23 Jan 2000 22:14:02 U
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: South End Press southend@igc.org

New book "Stolen Harvest" by Vandana Shiva

We are writing to let you know that world renowned environmental thinker and leader, the physicist Vandana Shiva, has published her thirteenth book, Stolen Harvest: The Hijacking of the Global Food Supply. Shiva will be touring Massachusetts and New York this spring.

Winner of the 1993 Right Livelihood Award, also known as the Alternative Nobel Peace Prize, Shiva has been prominently featured in the growing battle against globalization in agriculture and trade. In Stolen Harvest, Shiva exposes the impact of globalized, corporate agriculture on small farmers, the environment, and the quality of the food we all eat. For more information, including the table of contents and an excerpt from the book, please see http://www.lbbs.org/sep/stolen.htm

To order a copy, please call 800-533-8478. Fax review, desk, or exam requests to 617-547-1333. To schedule an interview with Vandana Shiva, to place a bulk order (discounts of up to 55% are available for non-profit organizations), or to co-sponsor one of her public events, please call Sonia Shah or Alexandra Etheridge at South End Press, at 617-547-4002.


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Date: 24 Jan 2000 00:42:04 U
From: BluPiaf@aol.com

FDA Botches Public Record of Opinion Statements

Hi all,

Just wanted to quickly let you know the latest FDA snafu, that might pertain directly to those of you that testified at any of the FDA public opinion forums on genetic engineering.

The FDA hired an outside company (Miller Recording Company) to do the reporting transcriptions, and they did not even bother to have Miller Recording double check the statements against the written statements the testifiers were REQUIRED TO PROVIDE to correct any mistakes by the Miller Recording transcriber who took down the public statements.

By the same token they themselves did not ask for the transcription computer disk to check the reporting against written statements. They just had this company come in and interpret what people said and how it was spelled to the best of their ability. There are many misspellings of key information that are on record without corrections in the FDA transcript and notated as "(phonetic)".

For example, the name of Dr. Arpad Pusztai, the researcher at the Rowett Institute in Scotland who dared to report the truth of his findings on the dangers of the CaMv viral promoter used in almost every single GE crop, was misspelled completely as "Bustai", consistently throughout my statement and those of others who referenced him in Chicago. At one point in my comment I referred to a study wherein "soy" was used as a feeding test. The Miller reporter wrote this word as "soil".

The FDA certainly proved they did not take the public opinions seriously. It is a disgrace, and is further evidence that the FDA is very content to not get ANYTHING straight for the record. As a result his mis-information will be referenced by the media, and organizations around the world. In order to correct the record, according to Miller Reporting, the FDA will have to pay them for each mistake the FDA made. THEY SHOULD BE REQUIRED TO DO THIS !!!

Please look up your statements at www.fda.gov, click on the Biotechnology box at the left of the page, and then, click on the meeting where you testified AND DOUBLE CHECK that any important information was not misspelled!!!!!! and call the FDA office in the city you testified. I haven't found out a number for the FDA (main number) in Washington yet. My FDA office is "checking into it" ha. ha.

As if you all didn't have enough to do. It would have been nice if we could have relied on the FDA to at least get our opinions, and the information in them straight for the record, if not for anything else.

FDA offices:
Chicago: 312-353-71276    Washington D.C: 301-827-3052    Oakland: 510-337-6845

Miller Recording, Washington D.C.: 202-546-6666

Christine Phillips
Chicago, IL    773-784-3698    Blupiaf@aol.com


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Date: 24 Jan 2000 02:55:50 U
From: jim@niall7.demon.co.uk

Death exposes risks of gene therapy

By James Meek, Monday January 24, 2000
http://www.newsunlimited.co.uk/international/story/0,3604,126204,00.html

Inquiry uncovers safety breaches and deception in case of teenager who died at esteemed centre

Sections:
Trials
Risk
Wake-up call

Trials

When Jesse Gelsinger, an 18-year-old volunteer from Arizona, died during trials of an experimental gene-based medical treatment last September, his father called him a hero and praised the scientists treating him.

But at the weekend, after US investigators probing an astonishing catalogue of safety violations and deception shut down all experiments at the once-esteemed Pennsylvania Institute for Gene Therapy, a shattered Paul Gelsinger was seeing his son in a new light: that of victim.

"Everybody was wrong," he said in a US interview. "Even me."

The Arizona teenager is the first person to die as a direct result of gene therapy, the medical revolution-in-waiting which promises to cure scores of incurable diseases but has yet to cure one.

In the wake of his death increasingly troubling accounts began to emerge of the institute's cavalier practices. But the radical move on Friday by the US food and drug administration to suspend indefinitely all seven gene therapy studies at the institute, one of the world's biggest, still shocked the international genetic research community.

In Britain, Norman Nevin, chairman of the government's gene therapy advisory committee (GTAC), said that there were no plans to re-examine the 40-odd gene therapy trials under way here in the light of the FDA's move.

About 350 patients are involved in the trials.

The GTAC, which licenses all gene therapy experiments in the UK, had already reviewed its programme after Gelsinger's death, Professor Nevin said. None of the British trials was directly comparable to what was going on in Pennsylvania.

Risk

"I'm very happy that no patient in the UK is at risk as a result of what happened to Jesse," said Prof Nevin.

Jesse Gelsinger suffered from an inherited liver complaint called ornithine transcarbamylase deficiency (OTC). The institute was testing a method of helping sufferers by using a modified cold virus to carry the gene which produced the deficient enzyme into their liver.

After he was injected with the virus, Gelsinger's immune system launched a massive counter-attack to reject it which destroyed his liver and spleen and badly damaged other organs, killing him four days later.

The institute is accused of giving Gelsinger too high a dose of the virus, ignoring clinical signs that Gelsinger was not fit to take part in the test and concealing from the authorities that previous volunteers had shown toxic reactions to the virus.

Investigators could find no evidence that all the 18 patients recruited for the trial had been fully informed of the risks beforehand. Consent forms were doctored without the authorities' permission to omit the fact that monkeys who took part in a similar trial had died.

Instead of screening the 18 for eligibility before they were recruited, the institute printed up eligibility forms only after Gelsinger died, leaving them unsigned and undated.

The institute, which has an annual budget of $25m, is headed by the distinguished James Wilson, past president of the American Society for Gene Therapy.

Dr Wilson has yet to respond publicly to the FDA's latest move. As founder of the biotech firm Genovo, he stood to benefit financially from a successful outcome of the trial which led to Gelsinger's death.

Genetic researchers and biotech lobbyists were trying to distance themselves at the weekend from what happened at Pennsylvania, arguing that it was down to bad administrative practice rather than bad science and that a crackdown by the regulators would ultimately be good for the field's image.

"I think the public will have more confidence if they know the FDA will enforce the rules," said Michael Werner of BIO, the Biotechnology Industry Organisation. The crisis at Pennsylvania comes as biotech shares are surging on world stock markets.

Wake-up call

"This is really a wake-up call, where perhaps we get a little comfortable with things as they're going on and then get a little cavalier," said Estuardo Aguilar-Cordova, a gene therapy adviser to the US national institutes of health.

The first gene therapy trials were in 1990. Hundreds are now under way around the world, none yet offering a definitive cure but all sustained by the enthusiasm of drugs companies, the desperate eagerness of sufferers from inherited illnesses and the conviction of scientists that breakthroughs are near.

Gene therapy covers a multitude of treatments, all involving somehow getting artificially manipulated genes into the human body to alter the way it works.

This can mean changing the genes of a virus to kill cancer cells, using a gene to trigger an otherwise inert drug, or - the greatest challenge - replacing genes which do not work properly.

It was this last method that the Pennsylvania team was trying to use. But their technique - injecting a cold virus modified to carry "good" genes directly into the bloodstream of a sufferer - was known to carry a risk of triggering an immune system reaction.

Prof Nevin said that 11 gene therapy studies were under way in Britain using the cold virus, or adenovirus, but none involved injecting into the blood.

Sufferers from inherited diseases fear that kneejerk public hostility to genetic medicine could rob them of a cure.

Bill Gleeson, spokesman for Britain's 200,000 sufferers of retinitis pigmentosa, a genetic defect which causes blindness, said: "There's a difference between clamping down on someone who might be a bit of a rogue and stopping research altogether. Early surgery costs lives. Early anaesthesia costs lives. You wouldn't want to turn the clock back on anaesthesia, would you?"


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Date: 24 Jan 2000 10:28:20 U
From: wytze geno@zap.a2000.nl

Mark wrote:

New Study Finds Organic Is Healthier

We've all suspected it. Now, a growing body of scientific evidence is indicating that organic food is healthier than conventional produce. Researchers from the University of Copenhagen recently reported that organically grown produce has higher levels of nutrients when compared with conventional produce.

Specifically, the organic crops had a higher concentration of vitamins and far more secondary metabolites, which are naturally occurring compounds that help immunize plants from external attack. Some of these metabolites are thought to lower the risk of cancer and heart disease in humans.

The research was funded by the United Kingdom's Soil Association (the largest organic farmer organization in the UK) and reported at the Association's January 8 conference.

These findings on the health content of organic food contrast with research indicating that industrial agricultural practices may be having a detrimental effect on the nutritional value of conventional produce. (Detailed in Organic View v.1 n.17, found at http://www.purefood.org/organicview.htm ) Those findings included:

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Date: 25 Jan 2000 00:08:27 U
From: rickved@bellsouth.net

Here is some exciting news – an update on Maharishi Mahesh Yogi's plan to bring organic agriculture to the world, and much more. Of special interest is the world-changing event he has planned for next summer.

------ Gerard Owmby

Govt leaders respond to Maharishi's plans

President Dr. Abdul Rahman Wahid of Indonesia and President Joachim Alberto Chissano Rama of Mozambique have responded to Maharishi Mahesh Yogi's plan to eradicate poverty in their countries through organic agriculture and to reject genetically engineered crops. They both met with Maharishi in Vlodrop, Holland for a special ceremony and a discussion of Maharishi's Seven Point Plan and his Eastern Alliance for Peace.

Maharishi expressed his hope that during these coming months many other governments will continue to respond to his plans. This will include building 17 skyscrapers, the tallest and largest buildings in the world, constructed according to ancient Vedic architecture, which will be used as universities to restore the ancient Vedic knowledge, including Vedic agriculture (organic agriculture). In addition, Maharishi's knowledge will be made available as video presentations over the internet, rendering obsolete his present system of global satellite transmission, and making it available to many more people worldwide.

During President Wahid's visit, Maharishi explained a seven-point plan for the transformation of Indonesia including development of unused land for organic agriculture, eradication of poverty through a new economic system, elevating the consciousness of the citizens of his country through the Transcendental Meditation and TM-Sidhi program, transforming the educational system, and redesigning all the buildings in his country according to Sthapatya Veda or Vedic architecture. In a gracious ceremony where he was surrounded by some of the world's greatest scientists and agriculturalists, Maharishi awarded President Wahid with a fully blossomed golden rose and made him a member of Maharishiis Eastern Alliance for World Peace which has already attracted the attention of several countries.

President Joachim Alberto Chissano Rama of Mozambique has just been re-elected and inaugurated for another five-year term. He has been practicing Maharishi's Transcendental Meditation technique for several years and said that he wants to use Maharishi's plan to transform education and eradicate poverty in his country. Maharishi encouraged him to act without concern for the opinions of those who would not understand the project or the profound knowledge being made available to his country. They both want very much to create peace and prosperity in the world and to move ahead with great speed and vitality.

To speed up the Seven Point Plan and its effects on their countries, both leaders also expressed their desire to participate in Maharishi's Vedic Vishwa Prashasan, which is a plan to create a permanent group of their citizens who will practice specific meditation techniques called TM-Sidhis in order to bring orderliness into the environment. Maharishi said, This will avert the danger that has not yet come. This final destructive power of natural law in genetic engineering is a crisis of world consciousness, and these mental technologies will restore Total Knowledge to every man.

It has been found that when the square root of one percent of the world's population practices the TM-Sidhis in a group, many significant social changes occur such as decreased crime, decreased accidents reported by insurance companies, decreased admissions to hospitals and mental hospitals, and decreased deaths in the war in Lebanon.

Forty-two independent scientific research projects have already verified the effects of these techniques on the environment. Among methods used were time series analysis using the autoregressive integrated moving average (ARIMA) approach of Box and Jenkins. Many of these studies have been published in respected scientific journals. Because of the novelty of this particular research, often extra experts were called in to examine the research before publication. Scientists who do not participate in the meditation have said that this research was more carefully carried out than was most research in the field of social science.

The chances that these orderly changes could occur in the environment on their own without the advent of the groups of Sidhas was one chance in ten to the minus 19th, or one chance in ten million million million. Scientists at the two celebrations said the effects of the Sidhas on the environment can be explained only by field effects according to quantum physics.

After an experiment involving the gathering of 8,000 Sidhas in 1980, the Cold War ended and the Berlin Wall came down. Inspired by that success, Maharishi has worked very hard to create a permanent group of 150,000 Sidhas, and will have that accomplished in July 2000. When this permanent group is established we will see a whole new world , Maharishi said.

Over 608 research projects have been done on the individual effects of the Transcendental Meditation technique, most of it published, which is more research than for any method of self-development. This includes everything from increased brain wave coherence, increase in I.Q., physical rest deeper than sleep, decreased stress, improved health, better social relationships, and beneficial effects on the environment.

Maharishi's full explanation of his Seven Point Plan and Vedic Vishwa Prashasan (150,000 Sidhas) can be seen at http://www.maharishi.org


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Date: 25 Jan 2000 08:11:47 U
From: Colleen Robison crobison@mnsinc.com

Brit. Patent on Clone Human Cells Raise Concerns

By Justin Gillis, Washington Post Staff Writer, Tuesday, January 25, 2000; Page A05

A patent newly issued by the British government appears to cover cloned human cells at the earliest stages of development, when they would in theory be capable of developing into a human being.

The patent, issued last week with little fanfare, is raising fears among a handful of anti-biotechnology activists that another ethical barrier has fallen, and that a nation has, in effect, countenanced the patenting of human life. This group, led by author and anti-biotechnology crusader Jeremy Rifkin, is preparing a challenge to the British patent, and will ask that it be narrowed or overturned.

Geron Corp., the California company that controls the patent, argues that it is necessary to protect the company's commercial interests. Ultimately, scientists hope to use the cells of sick people to grow replacement organs, such as hearts and livers, for them.

Geron acknowledges the technique would produce a microscopic ball of cloned cells that might be capable, briefly, of developing into a human baby –ut only if transplanted into the womb of a surrogate mother, something the company says it has no intention of doing.

"Does Geron intend to have Aldous Huxley baby farms?" said David J. Earp, Geron's vice president of intellectual property, repeating a reporter's query. "No."

Geron has a patent application pending in the United States. Beyond saying that it covers cloning of non-human mammals, the company refuses to specify precisely what is in that application. "Geron will provide further information . . . upon issuance of the patent," the company said in a recent statement.

The British patent grew out of the same line of research that created Dolly, the cloned sheep. It is one of two patents the British government has issued covering techniques and "compositions of matter" developed during the Dolly research, led by Keith Campbell and Ian Wilmut of the Roslin Institute in Scotland.

Roslin licensed the technology for most purposes to a commercial spinoff that was ultimately bought by Geron, a Menlo Park, Calif., company known for its research on aging and regenerative medicine. The license prohibits the use of cloning technology for human reproduction.

Britain, unlike the United States, does not have a vigorous community of antiabortion activists willing to argue that human life begins when a sperm fertilizes an egg. British law explicitly permits research on human embryos up through a very early stage of development, the blastocyst stage, when the embryo is still a thin, microscopic ball of cells. The Roslin patent covers cloned human cells through this stage.

Earp noted that the patent merely protects the company from encroachment by competitors in a field the company may or may not succeed in commercializing. The patent does not, he said, confer permission to engage in human cloning. Most countries have laws against human cloning or, as in the United States, have declared it to be illegal under existing regulations. Geron has repeatedly said that human cloning would be immoral.

Still, Rifkin and his allies believe the new patent crosses an ethical line. While Roslin's scientists limited their claim to the earliest stages of development, Rifkin and his attorney said they see no reason that existing law in the United States, to say nothing of Britain, would not permit patent claims on human babies up through birth. (At the moment of birth, all sides agree, babies acquire full human rights.)

Rifkin wants a prohibition on patents of embryonic cells written into law in this country and overseas. "Can you hold a human being as 'intellectual property' from conception to birth?" Rifkin said yesterday. "That's the issue here. The door is open." He said he would request congressional hearings.

Earp, the Geron vice president, does not see the matter so starkly. He noted that success in developing and commercializing the technology would save lives. "Many people die every year waiting for organ transplants," he said.

Cloning, however, is still inefficient and a long way, perhaps decades, from commercial use in producing organs. Patents generally come into play when a competitor tries to sell a product based on a company's proprietary technology.

While the current cloning technique requires creating the equivalent of an embryo, Earp said researchers are working to understand what is going on inside cloned cells. That might ultimately permit them, for instance, to use a person's skin cells to create a new liver without having the cells pass through an intermediate "embryonic" stage.

"We are," Earp said, "on the cutting edge not only of law but of science."

Patents on living organisms, from cell lines to improved plants and animals, have long been issued routinely in the United States and other countries. The patents include specialized human cells, such as cancer cells valued in the laboratory for their ability to reproduce forever. The U.S. Supreme Court decided in 1980 that a genetically engineered life form, namely a bacterium capable of breaking down oil spills, could be patented.

The new Roslin patent appears to be an incremental further step, for the first time covering a type of cell known to be capable of growing into an entire human being.

Staff researcher Richard Drezen contributed to this report. © Copyright 2000 The Washington Post Company


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Date: 25 Jan 2000 16:33:40 U
From: "j.e. cummins" jcummins@julian.uwo.ca

GM mucous-corn

By Prof. Joe Cummins, e-mail: jcummins@julian.uwo.ca, January 25, 2000

GM Corn-Human Mucous

Jan.1 Genetic Engineering News (20,16,2000) reports that corn has been modified with the human antibody IgA to be used for passive immunization. IgA is the antibody found in mucous , it is much more stable than the serum antibody IgG. Antibody produced in corn can be produced at one tenth or less the cost of laboratory reactor production. The downside is that human antibodies may create human allergies.

Furthermore field testing should be undertaken with great care. For example , field tests on GM tobacco crop with human interleuken were undertaken without care over pollution of ground and surface water and inadequate control of pollen release.

Spread of mucous corn genes or marketing mucous corn without labels seems to be a bad idea. For that matter , snot-corn flakes are unlikely to be a major market item. However, the GM advocates would likely find at least 125 submissive scientists to approve it.