[Thread]
GE -humans, animals and allergies
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- Subject: GE -humans, animals and allergies
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- Date: Thu, 28 Oct 1999 20:09:50 +0100
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1.A US biotechnology company is seeking to patent ..................
2.Dolly company in difficulties 3..[Human]GENE RESEARCHER DRAWS FIRE
4. from robert in NZ part human sheep
5.from robert in NZ - part human cows
6. Frankenword !!!
7.Industrial enzymes are top triggers of allergies and asthma
8.Human gene patents defended
9. Pirates are seizing the genome ========================================
>1. The Guardian (London) October 25, 1999 SECTION: Guardian > Home Pages; Pg. 1 BODY: Julian Borger in > Washington A US biotechnology company is seeking to patent > segments of the human genetic code in an attempt to cash in > on its research before British-led moves are implemented to > prevent the "human blueprint" becoming the private property > of a few corporations. Celera Genomics has stunned the > scientific world with its claim to have decoded about a > third of the entire blueprint, the human genome, in little > more than a month, and its prediction that it could > complete the job by next year, simultaneously or even ahead > of a parallel, publicly-funded, project underway in British > and US laboratories. The unravelling of the billions of > coded sequences in human DNA (the chemical base of all > genes) is expected to revolutionise medicine, and pave the > way to a new generation of genetically -based cures. It > could also open up limitless opportunities to influence > human evolution by manipulating genetic codes. Celera > claims to have isolated 1.2 billion of the estimated 3 > billion building blocks that determine the design of the > human body. It has caused consternation by seeking to > exploit its sudden lead in the human genome race for profit. > Contrary to its earlier assurances that its research would > be made publicly available, the Maryland-based company > announced last week that it was applying for patents on > 6,500 of its discoveries. "Celera's mission is to become > the definitive source of genomic and related agricultural > and medical information," the company said in a statement, > adding that the use of its data would be available "on a > subscription basis" to universities and other companies. > > Celera's mass patent application represents a gauntlet > thrown down in the face of efforts led by the British > government to negotiate an Anglo- American accord to ban > patents on the human genome and to ensure that the fruits > of the research are available worldwide to help combat and > prevent disease. The deal under discussion by Tony Blair > and President Clinton, reported in The Guardian last month, > would oblige all laboratories working in the field to waive > their patent rights. The British-owned Wellcome Trust and > the US National Institute of Health, which are leading the > publicly-funded research, would publish the code for each > gene within 24 hours of its discovery. In Congress, the > House Science Committee said it might hold special hearings > on the proposal by Celera, whose president, Craig Venter > told Congress last year that the company's research would > be freely available. The US patent office says it has > issued three patents so far for decoded segments of human > DNA and is considering up to 10,000 other applications. > > However, Jeremy Rifkin, the president of the > Washington-based watchdog the Foundation on Economic Trends > and the author of The Biotech Century, described the > patents as illegal. "Nothing in our patent laws allows > this. Under US law discoveries in nature are not > inventions. The US patent office has been violating its > statute," Mr Rifkin said yesterday. He said the Foundation > on Economic Trends planned to sue the patent office and a > number of biotech firms, possibly including Celera. Celera, > alongside other biotech firms, insist that so much effort > is put into isolating and decoding genes that they should > be subject to intellectual property rights. Otherwise, the > industry argues, there would be little incentive for further > research. Mr Venter, a former surfer with a penchant for pet > poodles, aged 52, insisted that the company policy remained > unchanged. "There are no losers in this system. Every > researcher in the world will have the human genome ahead of > time," he said. He worked on the British end of the Human > Genome Project until last year when he quit to start > Celera. The company uses super- computers to identify the > molecular structures which serve as the building blocks of > DNA. Such is the speed of the equipment that Celera has > effectively leapfrogged the publicly -funded Anglo-American > effort. However, its methods are less meticulous and > provide thinner information about what function each gene > segment serves - the crucial link to combatting disease. > > Francis Collins, the head of the National Human Genome > Research Institute, said mapping out the human genome was > only "the beginning of the road of discovery". "To make it > useful requires lots of additional steps that will be > inhibited if you put up a lot of tollbooths early on that > road and make people less interested in traveling at all.' > Mr Rifkin predicted that if companies like Celera were > permitted to patent genes, the costs of modern medicine > would rise exponentially. "Every patient in Britain and the > US is going to want to be diagnosed for certain genes, to > help prevent disease," he said. Doctors would be forced to > either provide the tests or face being sued. Mr Rifkin > warned: "The costs are going to break the healthcare system. > This will not hold." He predicted that as more and more > commodities are manufactured from genes, the contest over > ownership rights could become the one of the most important > economic battles of the next century.
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2.
Dolly company in difficulties (unknown source)
The company which helped clone Dolly the sheep, PPL Therapeutics, today announced 80 job cuts as part of a major shake-up. PPL said the cuts would mostly hit its production, research and administration divisions.
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3.
Subject: W.POST 10/26 MD.[Human]GENE RESEARCHER DRAWS FIRE
<http://www.washingtonpost.com/wp-srv/WPlate/1999-10/26/145l-102699-idx.htm
l>http://www.washingtonpost.com/wp-srv/WPlate/1999-10/26/145l-102699-idx.html
Md. Gene Researcher Draws Fire On Filings
Venter Defends Patent Requests
By Justin Gillis Washington Post Staff Writer
Tuesday, October 26, 1999; Page E01 A maverick gene researcher who told Congress last year that he expected to receive patents on "100 to 300" bits of human genetic material has filed preliminary applications on about 6,500 such gene sequences in the space of a month.
J. Craig Venter, the Rockville scientist who has been a lightning rod for criticism since he announced plans to unravel all human genes as a commercial venture, is drawing fresh controversy with the announcement. But he said his plans have not really changed and his critics don't understand U.S. patent law.
Celera Genomics Corp., Venter's Rockville company, says it has unraveled about a third of the human body's genetic instructions in one month and expects to publish a full gene map next year, five years before the original deadline set by the federal government. Mapping the genetic code promises to open up new possibilities for understanding and treating such ailments as cancer, AIDS and Alzheimer's disease. The potential profit and glory have set off intensive jockeying among researchers.
To Celera's many critics, including academic researchers locked in a race with Venter to be first to publish a gene map, the disclosure that the company has already filed 6,500 patent applications comes as proof of their longstanding argument that Venter is out to profiteer at the expense of public welfare.
"I think it's going to inhibit work on these genes," said Robert Waterston, director of a gene-sequencing center at Washington University. "I worry that both companies and people will not invest their time and effort into something if they think that things are tied up."
In sworn testimony before Congress last year, Venter said he expected to obtain no more than 100 to 300 genetic patents, and then only after careful study of their potential usefulness as treatments. He said he would put most of his data in the public domain for free, making it difficult for any researcher to stake out big patent claims on the human genetic code. "Our actions will make the human genome unpatentable," Venter said then.
The issue of gene patents has long been controversial. A clear body of law has developed in the United States and other Western countries that genes can be patented, but many academic researchers feel nonetheless that a sort of gold rush is underway to stake out excessively broad claims based on thin research. These critics fear that such broad, sloppy patents will slow medical progress.
"It puts us in a situation where there is such a tangled meshwork of patents and licenses that downstream research is actually inhibited," said Francis Collins, director of the National Human Genome Research Institute, which is competing with Venter. "A situation where somebody with a good idea is actually prohibited from pursuing it is not the way the public will benefit."
Some academic researchers have been excoriating Venter over the past two days after his patent statistics were reported in the Los Angeles Times and several British newspapers. They are accusing him of promising Congress one thing and doing another. But Venter said yesterday that his critics were misreading his intentions. The patent applications filed to date are "provisional" applications that establish the date of a discovery, Venter said. Such applications, permitted by U.S. law since 1995, can be filed cheaply and give a company one year to file a full patent application, which is more detailed and more expensive. The company's commercial interests are protected during that year.
Many companies--particularly in fast-moving, competitive industries such as biotechnology--file provisional patents as soon as they believe they've found something useful, then spend the next year deciding whether the application is really worth pursuing. Many of these applications are subsequently abandoned, though few companies will disclose exact numbers on how many they abandon. Executives of these companies see the provisional applications as an essential competitive strategy--if they don't file first, they reason, somebody else will.
"Everybody all over the world is working on the same thing," said Kenneth J. Burchfiel, a top patent lawyer in Washington who has no involvement with Celera or Venter. "Whoever plants that stake first potentially is going to get a patent on that [gene] sequence."
Celera expects to keep filing provisional patent applications, possibly totaling 20,000 or 30,000 by the time all genes are mapped. But Venter said a great many of those applications will be abandoned as it becomes clear the gene sequences specified in them are not medically useful. When he's through, Venter said, he expects Celera to have roughly the number of patents he told Congress he would have--a few hundred, not several thousand.
"There's a lot of people out there that want to make hay about anything we're doing," Venter said. "It's scare-mongering, and it's doing harm to the American public's ability to understand this complex field."
One thing is clear: As fast as Celera may be moving, other companies are far ahead of it in filing patents on genetic information. One of them is Human Genome Sciences Inc. of Rockville, with which Venter was once associated. That company, using a different research method than Celera's, has filed patent applications far more detailed than Venter's on about 6,750 human genes that it believes to be medically useful.
Venter said he had no ultimate control over how many gene patents will spring from Celera's research because big drug companies can subscribe to the company's database, use it to make their own discoveries and then file their own patent applications.
Venter added, however, that he remained committed to handing out the complete human genetic sequence without charge by sometime next year. He said the gene map would be put on a high-capacity computer disk, known as a DVD, and given to any researcher who wants it. (c) Copyright 1999 The Washington Post Company
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Date: 26 Oct 1999 22:46:41 -0500 From: Robert Mann <robt_m@talk.co.nz> Subject: part-human sheep
STATEMENT TO THE ENVIRONMENTAL RISKS MANAGEMENT AUTHORITY hearing 10-12-98 on an application to create & manage an expanded herd of part-human sheep in New Zealand
As we said in our prior submission, our association recently formed as the New Zealand branch of the international organisation Physicians & Scientists Against Genetically Engineered Food. Our members are interested and concerned about issues related to genetic engineering in general and have found it impossible to restrict our analyses to food only, so we recently decided to broaden our scope of activity. The professionals I represent align themselves with prominent scientists around the world who have come to see genetic engineering (GE) as the most menacing of all modern technologies. We are aware of how easily we may be seen as exaggerating, so we assure you that we have taken care to understate our concerns. My qualifications to advise you are appended in a brief c.v. Also appended is a talk on the general subject closely based on an article in press with The Ecologist, which happens to be the journal that has published the most fearlessly accurate criticisms of GE. I pass around for you a copy of the 'phoenix from the pulp' - the latest number of The Ecologist which was, when first printed at the end of September, pulped by the printer. I commend most highly to the ERMA this journal, especially articles by Professor Ho whose book on GE is the best you can get.
Science Having been thinking about GE for a quarter-century, and having recently discussed the broad topic with my most successful biochemistry students, I offer the ERMA some brief suggestions intended to guide, especially, those whose qualifications are less apparent. Here for example is a rough suggestion for how, on general biological grounds, you might rank your priorities for prima facie hazard.
A DRAFT ORDER OF INHERENT BIOLOGICAL HAZARD IN TRANSGENIC EXPERIMENTS
(from least to most hazardous)
within one species - the only type of transgenics we would normally approve, and then only after very careful detailed scrutiny
from one species to a related species e.g. potato to tomato
from a non-food related species to a food species e.g. _Arabidopsis_to mustard
from an unrelated food species e.g. salmon to a food species e.g. tomato
from an unrelated non-food eukaryote e.g. African clawed toad to a food species e.g. potato
from a non-food prokaryote to a food species e.g. TB bacillus to banana
and finally, the most perversely stimulating for the gambler-experimenter, from a non-food prokaryote to a non-food eukaryote - NuFood(r).
I doubt that you can make an informed assessment of a GE proposal without putting it through a series of logical sieves of which that is but one sketchy example. Have you created or adopted any such? If so, I suggest they should be published for the guidance of applicants and discussants. If you have not, people may wonder how you can discharge your statutory duties.
One neglected aspect of most if not all these experiments is the concept of 'genetic crippling'. In the mid-70s when GE first became a topic for ethical discussion, it was widely advocated that laboratory microbes used in even contained GE experiments should be handicapped (by special genetic modifications) from transferring genes to close relatives in the unlikely event of escape. Today transfer of genes to wild organisms is a rather common concern, but little mention is made of 'genetic crippling' to inhibit transfer of genes from escaped individuals or through transient visitors such as mosquitoes.
Regarding the present case, I bring forward here the section on it from my appended article because the applicant's previous history in this country is cogent. . . . the current attempt to genetically engineer human proteins in N.Z. sheep. A small Scottish company ("Pharmaceutical" Proteins Ltd - the 'Dolly' procreators & impresarios - financed by a large German multi-national) wanted to field-test in New Zealand ewes GE'd to make in their milk a human protein called by the unhelpful name alpha-1 antitrypsin (abbreviated AAT). The only reason stated for doing such experiments in N.Z. was this country's scrapie-free status. The Ministry for the Environment's Interim Assessment Group (IAG), although devoid of experts on prions (scrapie, BSE, etc.) and dominated by GE enthusiasts who appear to think that fears of GE are absurd, advised their Minister to refuse, which he did. Reasons, when reluctantly disclosed, turned out to be mere econobabble; prions were not mentioned. The IAG had previously approved a broadly similar proposal for making in goats' milk at Lincoln University another human protein with no therapeutic use (which had however been termed "pharmaceutical" by the experimenting company). Prevalent misinformation tending to favour the project, due partly to an anonymous 'news' report, requires correction in at least the following respects. (a) AAT-deficiency is equated with congenital emphysema, an unjustified jump beyond the evidence. Most of those born AAT-deficient do not develop lung disorders. Reports on N.Z. TV and in newspapers . . . have credited AAT as a treatment for emphysema; the public would take this to mean the common smoking-induced illness, greatly exaggerating the claim of usefulness. The congenital version is very much rarer - if a proper diagnostic category at all. (b) AAT is asserted to be in use now to treat congenital emphysema, whereas such crude preliminary trials as have been done prove very little. In fact there exists no use, let alone a market, for genuine human AAT which is routinely purified as a by-product and discarded in standard blood-bank fractionations. (c) AAT is implied to be very valuable, which factoid is then used to justify attempted production by genetic engineering ("U$100,000/y per ewe"). All this "future earnings" stimulates a stock-market ramp before anything saleable has actually been produced.
These are the essential facts as published by the Bay of Plenty Times in 1995 without evoking any purported correction. Anyone who agrees that they are indeed facts will immediately conclude that PPL are an unreliable party unfit to be entrusted with the conduct in our jurisdiction of any dangerous process. It is therefore particularly important to prove the facts of this matter. We are proud to bring - to help you discerning the facts - - Professor R B Elliott, one of the country's leading medical researchers. He will show that genuine human AAT is still far from medical use, and genetically-engineered AAT even further from use. PPL have persistently misrepresented these facts and have thus disqualified themselves from continuing their part-human sheep experiments.
It falls to me to add to whatever Dr Wills may say of himself that he has been a world leader in the select company of scientists working on prions. He is a founding member of PSAGEF and his recent article in the Herald exemplifies a rare gift for popular explanation of science. You can have confidence in his science. Furthermore, his speculations - all they are claimed to be - on AAT's possibly becoming a 'new prion' are as well informed as you could get. To point out known hazards is relatively easy - not that they have often been heeded - but the most menacing aspect of hi-tech has been the unpredicted disasters, so when an experienced critic of hi-tech looks a bit further ahead than most scientists can, his speculation is not to be lightly dismissed. The science of this case entails significant unresolved suggestions of not only new prions but also old-fashioned scrapie prions and the awful menace exemplified by BSE (mad cow disease) and its apparent human derivative. These concerns alone would suffice to wipe the PPL caper, even if it were put forward by trustworthy people. This should be a simple, brief case, liberating the ERMA for more complex cases which cannot be decided on such peremptory grounds.
It may be helpful to discuss overtly the fact that only a small minority of scientists have expressed misgivings about GE. (1) It is the merit of their reasoning that should prevail in your consideration, not the current sparsity of their ranks. (2) Considerable numbers of highly reputable scientists have in fact declared grave reservations about GE. The current impression within the Liberia of genetic engineering is misleading. Two decades ago the NZ Association of Scientists, whose membership totalled one-tenth of the nation's scientists, advocated a moratorium on GE in NZ pending a full public inquiry. But, since then, many scientists have been paid to perform GE in one form or another, and the NZAS has been taken over by their representatives. (3) My accompanying article points out that the ranks were vanishingly small in the decade 1955-65 of scientists speaking out against nuclear power which had an image of 'safe, clean and economical'. Today we are being told that GE is similarly OK, indeed beneficial. But in reality the benefits are being outrageously exaggerated, and the hazards shockingly understated, and the media have conveyed to the people almost pure hype and very little science. We have seen it all before. It is a form of social sleepwalking. Let the ERMA lead the nation out of this recent sleepwalk!
Ethics As a former medical-school lecturer still involved in a variety of ways with medicine and research, I condemn strongly the unethical raising of false hopes by PPL claims. Parents with the light of hope kindled in their eyes by PR hype confront the clinical experts who must then accept the unpleasant duty of breaking to them the news that PPL has not delivered any treatment for cystic fibrosis. A 'support group' has been organised, and publicised in the media, by one who claims to suffer from congenital emphysema (though she admits she formerly smoked) and has acted as if a volunteer PR agent for PPL, saying 'it's too late for me but others low in AAT need the PPL sheep' and laundering PPL's exaggerated claims. It is cruel to raise false hopes of treatment which is at best distant, certainly nowhere near proven utility, and may never become reality. And the ready availability of genuine human AAT, should it ever emerge from research as a pharmaceutical protein, makes the part-human sheep unnecessary. Lack of need is a very powerful argument. It would seem that the ERMA has to weigh benefits against risks. In the absence of any proven benefit to almost all of those who are exposed - - most of them involuntarily, many unwittingly - to whatever risks are entailed, the PPL project cannot be justified. This is the same logic which prevailed for us against the French government at the World Court. It is simple, intelligible and compelling. In that case, it was successfully argued by our government that the hazard entailed in the radioactive fallout to which all New Zealanders were involuntarily exposed need not be exactly quantified; indeed the task of quantifying it was a trans-scientific matter; but nonetheless there was no burden of proof on us to show how much harm was entailed, because there was precisely zero benefit to those thus exposed (all involuntarily, and some unwittingly especially in future generations). It was therefore unjust for the French nuclear explosions to force on New Zealanders any extra radioactivity, in the absence of any concomitant benefit. I must urge that if the ERMA rejects this logic you should say why.
Law Perhaps some explanation will be in order for my presuming to discourse on this sordid theme. I served a dozen years as a director of the Environmental Defence Society (patron Sir Guy Powles). EDS initiated many leading cases for conservation. I was thus been involved in numerous legal actions in the category Resource Management, while I was a main teacher in the field. Also I served for its first 11 years on the statutory board advising successive Ministers of Health on poisons, including lengthy consideration of draft legal regulations and later questions of enforcement. I have therefore dealt with more lawyers than might otherwise seem respectable, and have become what might be called a bush lawyer. I will not take up so much of your time as the real thing tends to; for one reason, no commercial clock is running in my favour as I speak. But I do wish briefly to attempt to give you a perspective on legal regulation of GE. It is commonly observed during the decay of a high culture that more and more disputes are handled through lawyers. Our country is no exception - the founding only a decade ago of yet another law school is among the abundant evidence. The presence of too many of the lawyer ilk in the Parliament which passed the HaSNO Act does not oblige us to steer these proceedings into channels calculated to bring more revenue into their trade. I remind you that, in my opinion, the present case need not take long at all. But, regarding many other applications, the scrutinising sieves and implied working rules which I have hinted at will require a lot of work - with which our physicians & scientists would like to help. The least unfair way to conduct that process of developing rules may be to declare a moratorium on new applications.
A party so incompetent and unreliable as PPL have shown themselves to be ought not to be entrusted with management of dangerous activities in our jurisdiction. It will not have escaped your notice that this conclusion means that not only should the present application be summarily dismissed but also PPL's current provisional permission, procured before our nation had any statutory regulation of genetic engineering, should be promptly withdrawn. The spirit of the old maxim "a perjurer must lose his case" is only the start of what PPL deserve, and we ask the ERMA to recommend accordingly.
The ERMA has set up a special committee for the purpose of advising on any proposal to, for example, insert a modified version of the gene encoding katipo toxin into kumara, then to be grown in experimental plots with a view to testing the vegetables as possum bait. I wish to warn against any dominant role for this group. Full commitment to conservation, to minimising violence, and to the rule of law, as argued recently by law lecturer D J Round in his book 'Truth or Treaty?', will allow very limited importance to the treaty of 1840. Instead of the main reasons for rejecting PPL's first declared version (near Tauranga) of their part-human sheep caper, the first effective barrier turned out to be the neighbouring Maoris whose objections counted more than the reasoned reservations of scientists. We do not want this hearing to result in a right decision but for what are only minor reasons. The major scientific and ethical drawbacks of the PPL caper should be declared as the grounds for rejecting PPL's application.
The Nuclear Analogy My appended article compares GE with another technology, at first sight very different: nuclear fission for the generation of electricity. There turn out to be many instructive parallels, as well as some interesting differences. Our nation disposed of the thrust to nuclear power by conducting a public inquiry into the whole question of how we should generate electricity. Public opinion, including some very prominent engineers, rejected nuclear power. I request the ERMA to examine the wisdom of a general public inquiry into GE. The need today for a Royal Commission on Genetic Engineering is evident and is enormous. While those who have some record of warning against dangerous technologies are saying that GE is on the whole dangerous and unnecessary, whereas the Royal Society of NZ parades Dr Richard Bellamy and Professor Sir John Scott around the country promoting GE, how can democracy grapple with this issue? The fabled "market forces" show no potential to assist and are indeed a main cause of the problem of ill-examined GE being conducted in various parts of this, the Liberia of genetic engineering. We believe the ERMA would be helping all legitimate interests, including its own development of operating rules, if it recommended creation of a neutral full public inquiry such as the ERMA itself is not able to conduct.
Closing We are grateful for the attention of the Authority, and we look forward to assisting it in future.
aaaaaaaaaaaa
- - Robt Mann CEO House Tuners Ltd National champion Kiwi Quiz P O Box 28878, Remuera, Auckland 1005, New Zealand (9) 524 2949
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5.
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Date: 26 Oct 1999 22:47:55 -0500 From: Robert Mann <robt_m@talk.co.nz> Subject: fw: part-human cows
This project is based on a scientifically dubious notion of producing human-type myelin basic protein (MBP) in the milk of GE cows. The most likely real motive is development of technology for GE in mammals (which is less developed than plant GE just now).
I send separately the evidence to ERMA of Physicians & Scientists For Responsible Genetics, 10-12-98, which led to the ERMA's approving expansion to 10,000 of the flock of part-human sheep belonging to PPL (the 'Dolly' impresarios). The jeers of fanatics notwithstanding, very serious objections have been carefully set forth to the relevant legal authority on these two GE capers (and others). A main point of these documents is to show that what is claimed to be very advanced legislation for regulating GE exerts little if any regulatory effect in practice.
TO: ERMA New Zealand 27 October 1999 fax: 04 - 473 8433
GMF98009 Genetically Modified Cattle
I am grateful for this further opportunity to comment on the material supplied by the applicant pertaining to putative benefits potentially arising from the proposed experiments.
I wish to draw attention to the discrepancy that appears to exist in the criteria used in weighing up the benefits and risks of proposals that come before ERMA.
The applicant claims diverse potential benefits. They are all speculative to varying degrees and neither of the major benefits derives directly from the proposed experiments.
In assessing risks and deciding what weight should be given to low probability events which may have adverse effects, ERMA has exhorted submitters to be specific and focussed. We have been asked to pay attention to the activities and events entailed in the proposal and not to produce general arguments or considerations of effects (like possible horizontal gene transfer) that would be more relevant in the case of an application for general release of an organism.
If the same criteria are applied to AgResearch's submission of 18 September (now released, with excisions, under the Official Information Act), then little or no weight can be given to the benefits whose assessed magnitude is "high", because these are benefits claimed to accrue to producers, processors and consumers (from enhanced milk casein and reduced b-lactoglobulin) and sufferers of multiple sclerosis (from MBP in milk), but not arising from the proposed experiments per se. The proposed experiments, if successful, will merely produce a situation in which those potential benefits can be explored. Consideration of these benefits would be relevant in the case of an application to maintain a "production herd" of the hypothetical cattle, in the same way (as we have been told) consideration of the risk of widespread pollen dispersal may be relevant to an application for commercial release of a crop, but it not considered relevant (by ERMA) to applications for "contained field trials". The claimed major benefits do not pertain to the proposed experiments and cannot, by ERMA's criteria, be given any significant weight.
What remains (in terms of direct benefits arising from creation of as-yet hypothetical cattle) are AgResearch's potential opportunities, (i) to use genetic modification to alter cow's milk and (ii) eventually to make money in the biotech-pharmaceutical industry. Those will be the direct outcomes of the proposed experiments. (Any of the supposed major benefits to producers, processors, consumers and sufferers of multiple sclerosis can only arise much later in the proposed enterprise.) However, consumer reaction to the genetic modification of food (especially if our country follows growing international trends) is likely to turn genetically-modified milk into an economic nightmare and advances in filamentous fungal expression systems are likely to render transgenic mammals obsolete for the production of putative pharmaceutical proteins like MBP. The major benefits claimed by AgResearch are not only highly speculative, they are also very uncertain and they will not ensue from the experiments themselves.
We are left with the claimed benefits of "new knowledge and scientific capability" and "development and employment opportunities". In both cases, what is claimed as a benefit is found by construing some positive consequence from the proposed experiments without considering negative consequences of a similar character. The fact that the scientific community gets together with government and decides on what it calls "high level goals for public good science and technology" and a new capabilities in manipulating the processes of life are found to be "innovative" and "exciting" does not in itself define any benefit >from the proposed experiments. Any such perceived benefit must be placed in the same category and weighed in relation to the perceived detriment that many submitters have referred to, whether they be those individuals, like myself, concerned with "the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social, and cultural well-being and for the reasonably foreseeable needs of future generations", or others, like Ngati Wairere, concerned with mauri, wairua and whakapapa. It is up to ERMA to weigh claims of good and bad which are put to it by different members of the public, irrespective of government policy or hyped-up enthusiasm for the so-called "knowledge economy" and our "Bright Future" in what is now termed "the immediate Foresighting era".
In my opinion, ERMA has a moral responsibility to transcend the intellectually corrupt perspective which is used by government to legitimate its political decisions concerning science funding. ERMA is bound to uphold the requirements of the HSNO Act, independent of the policies and actions of today's Ministers.
The claimed benefit of "development and employment opportunities" does not derive from the proposed project. It derives from the budgets of the organisations which fund the project. If they did not fund this project they would fund some other and virtually identical benefits would ensue elsewhere. It is merely a question of the availability of funds to a particular sector of the community. As a national quasi-judicial body ERMA cannot give weight to benefits accruing to one sector of the community as opposed to another, whether the sector under consideration be the scientific sector of the labour market or the Waikato sector of the economy. ______________________________
Presuming ERMA takes the view that there are no environmental risks that cannot be mitigated, it is now abundantly clear that ERMA's decision on this application comes down to nothing more than the wishes of AgResearch to pursue this line of biotechnological development against the wishes of those who do not want transgenic animals to be created for the purposes of producing food or putative pharmaceuticals. No technical considerations enlighten ERMA's judgment on what weight is to be placed on the wishes of these different groups of the community. It is a question of the different values that the different groups adhere to.
The major direct outcome of the proposed experiments, so we are now see, is experience in transgenics and AgResearch's exclusive ownership of knowledge (intellectual property), rather than any communal benefit. AgResearch has made no perceivable effort, except to try and persuade Nagti Wairere and others to their point of view, to mitigate the offence caused to some members of the public as a result of the proposed creation of transgenic cattle. Under such circumstances, public perceptions which are not represented by tangible effects, such as those that various submitters have referred to, deserve such weight as to prevail (cf the Mahuta and Northland cases) and the application must fail.
ERMA must distinguish the principles involved in consideration of this application very carefully from those involved in consideration of the PPL application. In that other case the applicant had every right to request consideration of the potential benefits of the availability of the a human protein as a putative pharmaceutical, because that was the purpose of breeding a "production flock". That is absolutely not the case in respect of the current application from AgResearch. The purpose of the current application is for AgResearch to manoeuvre itself into a (more) favourable position in the milk and pharmaceutical markets. The principle involved here is the public's right to have an opinion about whether or not this is an appropriate direction, from the standpoint of morals, values and personal beliefs, for progress in science and technology. The deep feelings of members of the public opposed to the intrusion of genetic engineering into agriculture deserve greater weight than the commercial ambitions of AgResearch.
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6.
> The Ottawa Citizen Monday, October 25, 1999 Final News A14 > Frankenword An editorial on Oct. 4 (and a correction on > Oct. 6) on the question of patenting life in Canada should > have said that it has been legally permissible to patent > single-celled, genetically engineered organisms (but not > higher life forms) since a successful appeal by the Abitibi > Company of Toronto to the Patent Appeal Board, decided in > 1982. We're sorry for the mutations that occurred in our > previous writing. ============================================
7.
Industrial enzymes are top triggers of allergies and asthma
(Summary of an article in the Swiss health magazine "PulsTip")
Industrial enzymes are top triggers of allergies and asthma, according to a new dissertation from the Swiss Federal Institute of Technology (ETH). A study with 110 participants showed that for 90% of asthma patients and 80% of neurodermitis patients, the symptoms either disappeared or were strongly reduced by eleminating industrial enzymes from their diet and from laundry detergents. Neurodermititis and food allergies have boomed since the 1960ies when the industry started to artificially add enzymes to foods and laundry detergents.
Industrial enzymes are used in a wide range of foods, to improve gains, processability, shelf-life, taste and other properties in flour, starches, pop drinks, fruit juices, oils, beer, whine, cheese and meat. These artificially-added enzymes don't have to be declared on the labels, and it is hard to avoid them. Many of these enzymes are produced by genetically modified organisms (GMOs), usually molds and bacteria. Since the produced enzymes are subsequently separated from the GMOs, the use of GMOs doesn't have to be declared. However, the separation is often incomplete, and residuals of the molds and bacteria are the main culprits of allergies.
Industrial enzymes are a vast business. Novo Nordisk, the Danish market leader, makes about $500 million per year with industrial enzymes. The gains in the food industry by using these enzymes and the market of anti-allergy drugs are even bigger (billion$). It's not surprising that the industry and allergy research establishment refused to comment or cooperate on the new ETH research.
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Wednesday, October 27, 1999 Published at 10:53 GMT 11:53 UK Sci/Tech
Human gene patents defended Celera says it will patent no more than 300 genes Celera Genomics Group has filed preliminary patents on 6,500 whole or partial
human genes, but will take only a few of them through the full patent process,
its president, Craig Venter, has said. Professor Venter said Celera would hold to a promise made at hearings before
the US Congress last year that it would seek to patent no more than 100 to 300
genes. He was responding to criticism that the patents will thwart promising genetic
research by academics, as well as competitors. Place in the queue The US Patent Office describes the preliminary patent applications made as
being 'place-holders' and one of several factors considered in granting a
patent. Dr Venter said the concerns were based on a misunderstanding of how patent
applications work. "It's just a step in the process. We have not filed a
patent
application yet on any genes." But it has emerged that Celera may in fact be running behind its competitors.
Human Genome Sciences, Maryland and Incyte, California, have each filed at
least 6,300 full patent applications. Incyte have been granted 173. Code for life Celera is one of several companies competing to map, or sequence, the human
genome - the entire collection of genes which holds the code for human life. Publicly-funded researchers, under the auspices of the international Human
Genome Project, are doing the same and have expressed outrage at the
patenting.
Many are doing it painstakingly. But Celera is using a "shotgun" approach,
sequencing random bits of genes in the belief they will all fit together when
they are done. Finished in six months Last week, Celera announced it had delivered 1.2 billion base pairs of the
humane genome sequence to its subscribers. Dr Venter believes this represents
about a third of the human genome, and hopes to be finished by April 2000 at
the latest. Some of the sequences have started to make sense, he said. "We found something
that could be very, very important in terms of viral disease -- a new
alpha-interferon." Alpha-interferons are natural immune system chemicals, some of which have been
developed as hepatitis drugs. Dr Venter said Celera had filed a preliminary patent application on this
particular whole gene. An anonymous pharmaceutical company on Celera's
subscriber list is now working to see if the gene will produce an alpha
interferon protein that might be used as a drug. Dr Venter said he thinks Celera's tentative approach to patent filings makes
sense. "We are not going to spend our company's money on a bunch of patent
filings. We are not going to try and get a portfolio of 10,000 gene patents on
speculative basis." The US patent office routinely grants patents on genes, the only country in
the
world to do so. This allows the holder to charge fees if anyone uses them
for a
commercial purpose. Professor Venter said it is the only way drug companies
are
going to use genetic information to make medicines - to invest in the research
they need the patent protection to ensure they recoup their money. Legal battle Scientists at the UK base of the Human Genome Project told the BBC that they
are "distressed" by Celera's decision to patent. Dr Mike Dexter said the Wellcome Trust, one of the project's major backers,
would launch a legal battle in the US courts to challenge the legitimacy of
patenting human genes. He added that more than a third of the human genome is already available on
the
Internet, with up to 90% of it due to be published by March next year. BBC online
====================================
9. Guardian Pirates are seizing the genome Britain and America have given big business an inhuman bonus George Monbiot Thursday October 28, 1999 If today's intellectual property laws had been in force during the 15th
century, British researchers have pointed out, Columbus could have patented
America. The explorers racing to discover the 21st century's new continent of
knowledge, the uncharted inner kingdom of the human genome, have their eyes on
riches which the old pirate navigators could only have dreamt of: they can
obtain a legal monopoly on everything they encounter. In 1995, MEPs defied the European Commission by rejecting its directive on the
legal protection of biotechnological inventions. Doctors, researchers and
patient groups had argued that patenting genes would make the diagnosis and
treatment of disease more expensive, laboratories more secretive and
scientists
less adventurous - disinclined to look for new cures if someone else owned the
genes on which they were based. Labour members of the UK parliament signed an early day motion supporting the
European parliament's decision and urging "the European Commission to reassess
its policy on biotechnology and genetic engineering to ensure proper respect
for human life". Thirteen of these MPs have since become ministers. In 1997, the commission re-submitted its directive. The new draft proposed
that
"An element isolated from the human body . . . including the sequence or
partial sequence of a gene, may constitute a patentable invention, even if the
structure of that element is identical to that of a natural element." The directive was supported by a massive corporate lobby and several European
governments. Britain's was by far the most aggressive. It argued that
companies
would be able to use the new law to patent the technologies surrounding
genetic
engineering, but not the genes themselves. Without "a favourable climate for
investment, based on the security of a firm legal framework", British-based
companies, it warned, would flee Europe for the United States and Japan. The directive would insure that EU patent provisions were "harmonised" with
those of the United States, as a step towards the global regime for which the
big biotech companies had been lobbying. None of the ministers who opposed the
bill in opposition raised a squeak of protest. One of them, Kim Howells, became responsible for insuring that British law was
compatible with the directive. The bill's critics, the government maintained,
were "scare-mongering" and "hysterical". At length, the European parliament succumbed to the multi-million pound
assault
on its intellect, and passed the re-drafted directive. On September 1 this
year, the bill became European law. The rest of the story hardly needs
relating. An American company, Celera Genetics, has done precisely what the
bill's opponents predicted, and staked a claim to a great chunk of the human
genome. Tony Blair and Bill Clinton have begged Celera to re-consider its
application, and Celera has chosen to ignore them. The blueprints of human
life
will become its private property. It will, if the British and American governments have their way, be able to
pursue its claims throughout the world. By January 1 2000, the signatories to
the general agreement on tariffs and trade must implement its "Trade-Related
Intellectual Property Rights" (Trips) provisions. Trips came about, according
to James Enyart, a senior employee at Monsanto, after "industry identified a
major problem for international trade. It crafted a solution, reduced it to a
concrete proposal, and sold it to our own and other governments". Both India and the Organisation of African Unity have decided to oppose the
Trips provisions granting patents on life, on the basis that they legalise the
theft of their biological resources. They are demanding that the
legislation is
re-negotiated. They will fight corporate attempts to force the rest of the world into line
with Europe and America by extending global property rights to the human
genome
during the world trade talks starting in Seattle next month. India and the OAU will be opposed at every turn by the two countries, Britain
and America, which claim to be contesting corporate attempts to monopolise
humanity. In the past, governments sought to protect their fleets from piracy. Today
they
arm the pirates and offer them legal protection, arguing that if they
failed to
do so the buccaneers would sail away and the native cut-throats would lose
their jobs. None of this, in the age of corporate government, should be surprising. What
does astonish me is that Blair and Clinton should profess themselves
nonplussed
when the pirates use the weapons they have been given, to open fire. signature:
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