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this text was exerpted from an IPS release that can be viewed in total at: http://www.link.no/IPS/art/eng/serv/WD/97/10/16/17.27_088.html
By Niccolo Sarno
BRUSSELS, Oct 16 (IPS) - Consumer organisations, development NGOs, academics, and environmental and farmers' groups have jointly called on the European Union to invest in food security -- and stand up to the food processing and biotechnology industries.
To mark Thursday, World Food Day, the groups urge the EU's leadership to reject a draft EU directive allowing the patenting of the genetic structure of living organisms, be they vegetable, animal or human, whether laboratory made or found in nature.
Such 'patents on life' are already legal in the United States and in Japan, where the gene or sequence of genes patented become the intellectual property of the researcher, institution or a private company which discovered, not invented, it.
Patenting of living organisms opens up new markets to pharmaceutical and agrochemical transnational companies, the only beneficiaries of such patents, notes the joint statement. It called the patenting of living organisms ''is an act of 'bio- piracy' which would dispossess local communities in developing countries of the wealth they protected and improved for centuries''.
The Commission's directive upholds the bio-engineers' rights to 'own' biological material while nominally restricting patenting of actual varieties of flora. ''Under its present form, the proposed directive allows the plundering of genetic resources of foreign countries, essentially Southern countries,'' warns the document.
Pursuant to the Norwegian Gene Technology Act ¶ 10 implementing the EEA Agreement, Annex XX no 25, the Norwegian Competent Authority has on the 1st of October 1997 made the following decisions;
The following releases have been prohibited
With respect to the products referred to in points 3-6, there is a possibility of antibiotic resistance genes being transferred to pathogenic bacteria. Antibiotic resistance is a steadily increasing problem in both human and veterinary medicine resulting in increased morbidity, mortality and costs. The existence of antibiotic resistance genes in the products therefore implies severe health risks.
Moreover, the antibiotic resistance genes have no function in the commercial products, and techniques for removing such genes are available. The possibility of using alternative marker genes in the modifying process exists, and indicates that other solutions implying no risk may be chosen. Hence the antibiotic resistance genes represent an unnecessary and unacceptable risk to health. Marketing of the maize, chicory, oilseed rape and tobacco is therefore considered not to be in accordance with the precautionary principle.
by Steve Connor and Deborah Cadbury
London Sunday Times October 19 1997 BRITAIN
SCIENTISTS have created an embryo of a frog without a head, raising the prospect of engineering headless human clones which could be used to grow organs and tissues for transplant surgery.
The headless frog embryos have not been allowed to live longer than a week, but the scientists believe the technique could be adapted to grow human organs such as hearts, kidneys, livers and the pancreas in an embryonic sac living in an artificial womb.
If human cloning becomes possible and many scientists believe it is inevitable following the birth of Dolly, the first adult sheep clone the two breakthroughs could be combined so that people requiring transplants could have organs grown to order from their own cloned cells.
The advantage of using human clones is that organs could be grown that would perfectly match the patient requiring a transplant and there would be no need for drugs to prevent tissue rejection. It would also solve the increasing shortage of transplant organs.
Growing parts of human embryos to cultivate organs could bypass many legal restrictions and ethical concerns, because without a brain or central nervous system the "organ sacs" may not meet the technical definition of an embryo. The scientists nevertheless accept that many people would still find the research repugnant.
Jonathan Slack, professor of developmental biology at Bath University and a leading embryologist, says he can now create headless frog embryos relatively easily by manipulating certain genes. Using the technique, he has been able to suppress not only development of a tadpole's head, but also its trunk and tail. Under current Home Office rules, they are not considered animals until they are a week old, when they have to be destroyed.
He said the breakthrough could be applied to human embryos because the same genes perform similar functions in both frogs and humans.
Using intact cloned human embryos to grow organs would be out of the question because they would have to be killed and this would be equivalent to murder, Slack said.
"It occurred to me a half-way house could be reached. Instead of growing an intact embryo, you could genetically reprogramme the embryo to suppress growth in all the parts of the body except the bits you want, plus a heart and blood circulation," he said.
Neither would it be acceptable to grow parts of a human embryo as an organ sac inside a woman's womb. "More acceptable might be taking a single cell and somehow growing a complete organ in a bottle from it," said Slack.
He nevertheless believes the enormous technical problems can be overcome. It was the cloning of frogs 30 years ago that led to the cloning of Dolly. Scientists at the Roslin Institute near Edinburgh, who created Dolly, said earlier this year that the first human clones could be produced within two years.
Slack's ideas have angered some academics. Professor Andrew Linzey, an animal ethicist at Oxford University, denounced his research.
"This sort of thinking beggars belief. It's scientific fascism because we would be creating other beings whose very existence would be to serve the dominant group. It is morally regressive to create a mutant form of life," Linzey said.
Other scientists, however, support Slack in raising the profile of such controversial research, which is described for the first time in a BBC2 Horizon documentary this week.
Lewis Wolpert, professor of biology as applied to medicine at University College London, said Slack's suggestions were perfectly sensible and could in principle be possible. "There are no ethical issues because you are not doing any harm to anyone.
"It is a question of whether it is acceptable or not to the public and that depends on the 'yuk' factor."
===================================** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving this information for research and educational purposes. **
© Gina Kolata 1997
Extracted from Clone:
to be published by Allen Lane the Penguin Press, at &Pound;15.99.
London Sunday Times October 19 1997
On a soft summer night in July last year, the most famous lamb in history was born in a shed just down the road from the Roslin Institute in Scotland, where she had been created.
The lamb was a clone, born not out of the union of a sperm and an egg but out of adult genetic material from a sheep's udder. This was a scientific milestone equal to the splitting of the atom. Yet her birth was a moment of remarkable insouciance. Nobody broke open champagne. Nobody took pictures. Only a few staff members from the institute and a local vet were present.
Her creator, Ian Wilmut, does not remember where he was when he heard that she was born. He does not even recall getting a telephone call saying she was alive and healthy and weighed 14lb.
He named her Dolly, in a moment of frivolity, after Dolly Parton who was also known, he said, for her mammaries. Then he kept her birth secret until February this year, when the announcement provoked a furore. It was one of those rare events that alter our notion of what it means to be human, because, using Wilmut's technique, human adults could theoretically now be cloned, too.
Until Dolly entered the world, cloning was still the stuff of science fiction, relegated to the realm of hoaxers and eccentrics. Yet Wilmut is the antithesis of a mad scientist. He is an embryologist of impeccable credentials, with a gentle face and neatly cropped auburn beard. Quiet and modest, he tries to alleviate the pressures of sudden fame by walking in the mountains near his home.
His goal in cloning was to develop animals that could produce drugs for human use. As a result of his breakthrough, however, scientists dream of using cloning to make our own body parts for transplantation.
Dolly now lives under guard at the institute, where she is known for her powerful personality. Wilmut gets letters from people wanting their loved ones cloned. And the stars of the scientific world who had never heard of Wilmut before his announcement are still trying to come to terms with the fact that a lowly animal embryologist achieved what many had assumed to be impossible.
It is only now, months after Dolly was unveiled to the world, that the true extent of this achievement can be revealed.
Wilmut and Keith Campbell, his collaborator, battled against mainstream science's indifference to create Dolly. They were inspired, however, by another scientific outsider known for both his brilliance and eccentricity. Dolly's true story is an extraordinary tale.
Scientists have long known what was involved in trying to clone, but many convinced themselves that it was biologically impossible to clone from adult cells, as Dolly was.
The problem lay in the mysteries of embryo development. Every cell in the body arises from the same fertilised egg and has exactly the same genes. But animal and human cells are specialised, "differentiated", so that a heart cell behaves like a heart cell and a liver cell like a liver cell. This process of differentiation begins almost as soon as a foetus forms, and once a cell has reached its final state, it never alters. A brain cell never turns into a liver cell, even though its genes are the same. So how could a cell from one part of the body be cloned into a whole new body?
Embryologists have been looking for the answer for most of this century. Early cloning experiments involved the simple division of embryos in the earliest stage of development, when they have only two cells. A scientist called Hans Spemann took a hair from the head of his newborn baby boy, tied it into a noose and slipped it over a two-cell embryo from a salamander. If the embryo split in two, it produced two identical salamanders. If he merely pinched the embryo with his noose, it grew into a two-headed monster.
In 1952 two American scientists achieved actual cloning adding an isolated nucleus to a frog's egg, whose nucleus had been removed. But this worked only with very "early" embryos. Nobody could clone an adult frog from an adult frog cell.
Human cloning seemed so far off that J B S Haldane, the near-legendary British biologist, could speculate that it would be a tremendous boon if it ever happened, increasing the number of great thinkers, great artists, great athletes, even great beauties. He suggested that "probably a great mathematician, poet or painter could most usefully spend life from 55 years on in educating his or her own clonal offspring".
By the 1970s, however, cloning had become the stuff of fictional nightmares. Haldane's own sister, the novelist Naomi Mitchison, wrote a chilling book, Solution Three, about a nuclear war that almost destroys humanity. The survivors remake the human race by prohibiting sexual reproduction while cloning their best specimens: the man and woman deemed least aggressive. Disaster ensues. Those who are not clones rebel, and even the clones turn out to be aggressive. In Ira Levin's 1976 bestseller, The Boys From Brazil, the notorious Nazi doctor Josef Mengele tries to raise clones of Hitler to conquer the world.
This made cloning such a buzz word that when a New York publisher rushed into print in 1978 a book by a freelance writer called David Rorvik, who said he had helped an eccentric multi-millionaire to clone himself, people believed him. By the time a court declared the book to be "a hoax and a fraud", Rorvik had earned $390,000 from it and the publisher $730,000.
Many scientists reacted to the Rorvik scandal by insisting that cloning was not even on the horizon. But almost immediately a German researcher, Karl Illmensee, announced that he had cloned three mice. It was the first time that anyone had cloned a mammal.
Or had he? Scientists in Illmensee's university lab in Geneva thought something was amiss. When their mild wariness turned to outright disbelief, they said so publicly and caused a sensation. An international commission found that while Illmensee seemed to have been extraordinarily sloppy, the fraud charges were unproven. A more devastating verdict was to come, however, when two of the most respected scientists in the field analysed Illmensee's work and concluded that the cloning of mammals by his method was "biologically impossible".
After the Illmensee affair, mainstream embryologists gave up on cloning and it was relegated to agriculture departments, where unknown figures laboured among the odours of farmyard animals.
These animal scientists were not part of the elite of developmental biologists. "These agriculture people, whom I've never met, don't talk to the mouse developmental biology people, " said Lee Silver, the director of a molecular biology lab at Princeton University. "We don't ever come to the same meetings."
Which meant that the mainstream didn't know about a Danish iconoclast called Steen Willadsen, who has near-mythical status as cloning's secretive innovator.
Willadsen spent most of his childhood on a dairy farm in Jutland. With a Danish PhD in reproductive physiology, he joined the British Agricultural Research Council's unit on reproductive physiology and biochemistry in Cambridge, the mecca for livestock embryology, in the early 1970s on just ś80 a month and started doing astonishing work.
As a Milk Board fellow, his main work concerned cows. But he used sheep whenever he wanted to try something new. "Sheep were sort of mini-cows," he said. They had more offspring than cows and were less expensive. At one point, he was taking care of 400 sheep and would take orphaned lambs home at night, bottle-feeding them.
Willadsen began creating chimeras, animals that were made by mixing together cells from two different sheep's embryos. It was intricate microscopic work. "I would grab the egg with a pipette and with a small needle cut a ridge all the way around the egg," he said. Slicing through the gelatinous shell that surrounds the egg, he exposed the embryo inside. Then he would remove single embryo cells by sucking them out with a pipette so fine that only one cell could enter it at a time. He would replace them with cells he had removed from another embryo, close the egg shell and allow the chimeric embryo to develop.
He further found that by moving nuclei of embryo cells into unfertilised sheep's eggs which had had their nuclei removed, he could readily produce cloned embryos to implant in the uteruses of surrogate mothers. In 1984 two lambs were born in this way proof that mammals could be cloned from young embryos.
Willadsen also mixed embryo cells from different species, creating sheep-goats and even sheep-cows, which looked like sheep with spots. When he left the Cambridge lab in 1985, he roasted one of his sheep-cow chimeras at a farewell party for his closest scientist friends. "It was not very tasty," he confessed, "but that was because the sheep part of it was too old it should have been eaten when it was a lamb."
His new job was with a cattle company in Texas. While there he took his advances a stage further by cloning calves from older "differentiated" cells the cells which scientists thought could not be cloned. He never published this breakthrough, however. He had done the work only to prove to himself that he was right.
As nobody knew about Willadsen's achievement, cloning remained a scientific backwater. Yet at the very time cloning seemed to have finally disappeared from the scientific landscape, Ian Wilmut was quietly taking it up at Roslin. Few mainstream scientists knew anything about him. Even the people of Roslin paid little heed except to complain about the smell from the pigs, sheep and chickens at the research institute.
Wilmut is one of the most unlikely heroes of the cloning saga. Quiet, self-effacing and cautious, he grew up in Hampton Lucy, near Warwick, the son of schoolteachers. When he was 10 he met a sailor, and becoming a sailor was all he thought about until he discovered, at 14, that he was colour-blind and turned to farming as another open-air career. He started working on farms at weekends and he took a degree in agriculture at Nottingham University. But he doubted that he would make it in the farming business: "I realised that I don't have a commercial knack at all."
While still an undergraduate, he spent a summer at the same Agricultural Research Council unit in Cambridge where Willadsen was later to work. The mysteries of embryo development, the sheer thrill of seeing life at its very inception, were irresistible to him.
He became a Milk Board fellow there and in 1973 after almost emigrating to Australia he found a job at the Animal Breeding Research Station in Roslin, which was later to become the Roslin Institute. He and his wife Vivian relished the rural setting: the fields dotted in the springtime with dandelions and clover, the quiet town of Roslin, and Edinburgh just seven miles away.
While Vivian took care of their children two daughters and a son, now in their twenties he began his scientific career, labouring nine hours a day, leaving the lab at six each night and, more often than not, bringing work home.
His salary was always modest when he created Dolly he was earning ś37,500 a year and stood to gain little if his methods were commercially successful; even the cloning that resulted in Dolly would provide him with at most ś15,600 a year but he was content and became known among animal scientists as a solid, honest researcher.
His first project was to investigate why livestock embryos often died before being carried to term. In 1981, the institute shut this project down and Wilmut was told to work on a project injecting genes into embryo cells. "When I say I was told, I was told," Wilmut said.
The idea was to make genetically engineered animals. A scientist like Wilmut might, for example, add a gene for a protein like insulin to a sheep's cells and arrange it so that the gene was turned on in udder cells when the sheep made milk. The result would be a sheep that produced insulin in its milk.
It was tedious work. Cloning might be a better way, Wilmut reasoned. Perhaps, he thought, he could take older cells from foetuses or even adults, grow them in the lab and add genes to them. The drawback was the old problem that cloning from any but "undifferentiated" early embryo cells was impossible.
Then, in 1986, Wilmut was chatting to a vet in an Irish pub after a scientific meeting. The vet had worked with Willadsen in Texas and he confided Willadsen's secret: he had cloned from cattle embryos 60-120 days old, breaking the shibboleth about undifferentiated cells. Wilmut was stunned. If this were true, it might be possible to clone from adult farm animals.
Sitting next to Roger Land, the Roslin Institute's research director, on the plane back to Scotland, Wilmut insisted: "We've got to look into this."
Willadsen, they knew, was the sort of wild and crazy scientist who inspired apocryphal stories. So Wilmut tracked him down in Canada where the Dane had moved from Texas and asked if the story was true. It was. "He was very helpful."
Even armed with this information, it took Wilmut another three years to find commercial sponsors who would support the cloning research. Finally, money for about two months' work came through, and he sought a cell biologist to help him. He found Keith Campbell, a long-haired, Birmingham-born research fellow at Dundee University who had always wanted to try to clone mammals.
Working on sheep "sheep in Scotland are very, very, very cheap" Campbell set out to solve the cloning problem. He decided to exploit the fact that cells can interrupt their normal growth cycle and put themselves into a state of suspended animation, which biologists call G0, for "gap zero". Campbell reasoned that if he starved cells until they were on the verge of death, they would all be synchronised in the G0 stage and might be in the perfect state for cloning.
Campbell and Wilmut starved foetal skin cells, forcing them to enter the G0 state, and then tried cloning. These cells were differentiated cells and, in theory, should not have cloned at all. But the results seemed promising. Campbell was beginning to suspect that he was about to make history.
He and Wilmut ended up with 14 embryos seven of them cloned from cells that had flattened and differentiated in the lab and looked like skin cells. All the clones were from Welsh mountain sheep, a species that is white with curly fleece. They were placed in blackface sheep as surrogate mothers.
Five of these 14 pregnancies progressed. In the six weeks before the ewes were due to deliver their babies, Campbell began sleeping on the floor of his tiny cluttered office at the Roslin Institute each night, waking every hour to check the pregnant ewes.
In July 1995, the ewes went into labour, giving birth to five lambs. Two survived. Both were clones of differentiated cells a scientific breakthrough. Campbell and Wilmut named them Megan and Morag. They wrote a paper for Nature, announcing their feat. It was published on March 7, 1996. But because it involved farm animals, many scientists seem to have ignored it. Their achievement went largely unnoticed.
Perhaps it was this atmosphere of blind indifference to their work that gave Wilmut and Campbell the courage to try to clone an adult sheep. Strictly speaking, this was unnecessary as they had proved that they could clone from foetal cells grown in the lab.
The cloning of an adult was more of a lark, a way to see if they were right that there were no longer any boundaries in cloning.
"I think people thought I was mad," Campbell said. "I remember telling people at a meeting that my aim was to clone an adult and that I would do it within the next two years." Their reaction, he said, was "yeah, yeah".
Campbell, however, was supremely confident. "One advantage I had is that I don't believe what people tell me. I never did."
The keys to his confidence were the proteins that coat DNA in the nucleus of a cell. These proteins mask as many as 90% of a cell's genes, leaving open only those that the cell needs in order to survive and to perform its specialised function as a brain or liver cell or whatever. Cloning involves enticing the DNA to lose these proteins so that the cell can return to its "undifferentiated state" and become the first building block of an entirely new being.
"I look at it like this," Campbell said. "We've got all the bits for building something and we've got the instruction manual. But as the original vehicle was built, people translated the bits they didn't want into a different language. So it's a matter of getting all the information back together again, translating it back to the original language and putting the bits back together again." Of course, he confessed, "that's a tall order", and no human being knows how to do it. And so, said Campbell: "I tried to think of ways of getting cells or eggs to do it for me without knowing what they were doing."
Wilmut began looking for a collection of adult cells to grow in the lab. He came across vials of frozen udder cells from a six-year-old Finn Dorset sheep that had lived on another farm and seems already to have been dead when he found them.
"She was put down," Wilmut explained to me over lunch. Some unknowing people butchered her and sold her. The sheep was eaten. Her udder cells were merely cells of convenience.
It sounds like a tale by O Henry. What should be the second most famous sheep in history, the ewe that Dolly was cloned from, died in anonymity and was probably eaten by some unsuspecting Scottish family. Yet it shows, once again, how profoundly nearly everyone involved in the Dolly experiment misread its importance.
Not thinking that they might one day be plagued with questions about what happened to that six-year-old ewe, Wilmut and Campbell started their cloning experiment. After starving the udder cells so that they would enter the G0 phase and become quiescent, Campbell sucked the nucleus out of an egg from a ewe, so that it had no genes at all. Then he slipped an udder cell under its outer membrane.
Next, he jolted the egg for a few microseconds with a burst of electricity. This opened the pores of the egg and the udder cell so that the contents of the udder cell, including its chromosomes, oozed into the egg and took up residence there. Now the egg had a nucleus the nucleus of the udder cell. In addition, the electric current tricked the egg into behaving as if it were newly fertilised, jump-starting it into action.
It was laborious work. Wilmut and Campbell got 29 embryos out of 277 udder cells that they tried to clone. After growing the embryos for a week, they transferred them into surrogate mothers which were Scottish blackface sheep so the mother would look different from her baby if any of the cloned embryos developed into lambs.
John Bracken, a specialist in monitoring sheep pregnancies, was put on alert. His first ultrasound scans showed that many of the foetuses had been lost. But one animal was still pregnant. The attempt to clone an adult sheep was working.
Campbell's wife insisted that she did not want him to spend another six weeks sleeping on the floor of his office. He hired someone else to sleep in the lab and, confident that all was going well, went on holiday.
On Friday, July 5, 1996, the surrogate mother carrying the clone of the adult sheep went into labour. Bracken attended the birth, but did not call Wilmut. In part this was because blackface sheep are skittish around human beings: if a crowd gathered, she might panic and the lamb might be lost. But in part it was also because Bracken did not appreciate what a momentous birth this was.
Nor did Wilmut. Although Bracken called him as soon as the lamb was born, Wilmut's response was muted. "It's bizarre, but true that we didn't get lit up on the day Dolly was born," Wilmut said. "It absolutely sounds absurd now."
He added: "I had actually brought some champagne." But he never opened it. "One of the factors was that Keith was away and it seemed wrong to celebrate without him. This had been a team project."
Campbell telephoned the lab every day to see if the ewe had given birth. But, he said: "I knew it was going to work. I always thought it would work once we had Megan and Morag. We were just proving a point I'd already made."
Wilmut had frozen some of the original udder cells to prove, through DNA fingerprinting, that Dolly's genes were the same as those of the udder cells.
At first, Dolly behaved like a perfectly ordinary sheep. But, Bracken said, "as she became more and more famous, she rapidly became aware that she was different".
Unlike other sheep at the Roslin Institute, which graze outside on sunny days, Dolly is kept in a pen inside a locked cement block building. She has never been outside, never eaten grass, but instead gobbles dark brown pellets of sheep food concentrate. Bracken explained that scientists were worried about security and also wanted to protect Dolly's health. "Here she is in a controlled environment," he said. "If we put her outside, she would be at risk of diseases spread from other animals and weather conditions, all of which could jeopardise a healthy animal." And nobody wants to take a chance with Dolly.
For the first 10 months of her life, Dolly shared a pen with Megan and Morag, but by last May she had to be separated from them. She would assert herself by turning over her trough as soon as she had finished eating and planting her forefeet on it. Then she would stand, chest puffed out, the queen of the pen. She was also growing fat. Every scientist who came by wanted to pet her and to feed her. Megan, in the meantime, had fallen pregnant and had a lamb, and Morag was now pregnant, so they needed extra food while Dolly needed less. The only solution, the scientists decided, was to separate them from Dolly by a low fence.
Dolly knows she is special. Most sheep are wary of humans and retreat to the back of their pens when people come near. Not Dolly. She rushes to the front of her pen when visitors arrive, bleating loudly. Is Dolly the clone of an egomaniac or is this acquired behaviour? Until another sheep is cloned from those same cells, which remain frozen at the Roslin Institute, we won't know.
In Roslin, people seemed baffled at first by the attention Dolly was getting. "A sheep is a sheep is a sheep," said Grahame Harris, proprietor of Ye Olde Original Inn.
But the rest of the world seemed to understand all too well what Dolly meant, and with a belated sense of history in the making, Wilmut does, too.
Such are the pressures that Wilmut is finding it hard to think, to say nothing of planning new experiments, as he deals with an unending stream of requests from politicians, from scientists and from the public. He and Campbell have been peppered with messages from people who want to weigh in on the ethics of cloning or, just as often, want a pet or a dead family member cloned.
He knows that for some people cloning raises dark prospects: that they ask whether some day we could clone ourselves and make tens, dozens, hundreds of genetically identical twins their characters "improved" beforehand, genetically engineered to add some genes and snip out others.
"I know what is bothering people about this," Wilmut said. "I understand why the world is suddenly at my door. But this is my work. It has always been my work, and it doesn't have anything to do with creating copies of human beings."
He tries to keep a low profile and avoid getting into ethical debates about cloning humans. Although his wife is an elder in the Church of Scotland, he is not religious "I consider myself an agnostic" and he fears that his arguments might be attacked because of his beliefs "or lack of them".
But his opposition to human cloning is absolute. He is offended by the idea of trying to create a copy of someone who has already been born, and he would worry about the pressures parents would put on a cloned child. When it comes to cloning a person, he says: "I don't find it frightening, I find it sad."
© Gina Kolata 1997
Extracted from Clone: the Road to Dolly and the Path Ahead, by Gina Kolata, to be published by Allen Lane the Penguin Press, at ś15.99.
==================================** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving this information for research and educational purposes. **
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