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Baby Bursts out of Bubble NZ Herald 7 Apr 2002

After gene therapy little Rhys Evans can go out to play for the first time in his life. Steve Connor reports.

This time last year baby Rhys was down with pneumonia and needed a venilator to breathe. Suffering from a rare inherited disorder that had robbed him of a working immune system, Rhys had to live in an ultra-sterile hospital room cut off from the world.

Today, the 18-month-old toddler is like any other little boy of his age - full of mischief and fun, with an insatiable desire to run around whenever he can. He lives at home and shows no sign he was once so ill. Doctors at Great Ormond Street Hospital, London, said this week Rhys is living proof that gene therapy works. Some of them went as far as to say he has been cured - the fhst gene therapy patient to receive that accolade in Britain, and only the second gene therapy "cure" worldwide.

"We're very pleased to announce the successful cure of the first patient in the UK by gene therapy," said Professor Christine Kinnon, director of the Centre of Gene Therapy for Childhood Diseases at the Institute of Child Health in London, who collaborated on treatment. It is rare for doctors to use the "c" word. Cures are meant to be pemianent and, although Rhys shows every sign he is now normal, there is still a risk he may relapse, making him once again vulnerable to the opportunistic infections that strike someone with a compromised immune system. Indeed, Adrian Thrasher, the consultant Paediatric immunologist at the Great Ormond Street Hospital who carried out the treatment, was more cautious. "I'd like to say that Rhys is cured but we can't say that," he said. "Rhys will be followed up for years and years. Only in the long term will we really be able to compare what we've done to Rhys with our other patients who've been through more conventional transplant procedures." The first signs that something was wrong with Rhys came four months after his birth about the time his mother, Marie Evans began to stop breastfeeding. A series of chest infections quickly turned into pneumonia which led to lo days in an Oxygen tent before being put on a ventilator. After a series of tests, the problem was finally identified. Rhys had acquired a defective gene on the X-chromosome - inherited from his mother. It meant he could not produce the vital lymphocytes - a type of white blood cell-essential for his immune system.

Medically, the condition is called X-linked Severe Combined immunodeficiency (X-SCID). The more popular name is "baby in the bubble" syndrome - because of the sterile plastic spheres used to protect some babies with the disorder. An analysis of Rhys' blood showed the few lymphocytes he possessed came from his mother and the supply had been cut off when breastfeeding ended. Marie Evans, 31, remembers the pit of despair. "One day we would be up and the other day we could be down." Mark Evans, her husband, gave up hisjob to care for Rhys and suffered badly from depression and anxiety. "if you'd seen how bad he was ... He was skin and bone, too weak to hold his head up," he said. When Rhys regained enough strength, he was transferred from the South Wales hospital to a sterile room at Great Ormond Street. Doctors soon began the search for a bone marrow donor. It was the one source of hope for Rhys, who did not have a brother or sister to act as a tissue-matched donor. For the past 20 years or more, bone marrow transplants have been an effective treatment for disorders of the blood and immune system. But without a suitable match, a transplant was impossible. Marie Evans said: "We were told one day there wasn't a match in the UK. We looked worldwide and we were told there was an American donor and the next day we were given the opportunity of gene therapy." The first stage of the operation was simple enough. Under a general anaesthetic, doctors extracted bone marrow cells from Rhys and froze them. They genetically engineered a mouse retrovirus - a type of virus with a natural capacity to inject genetic material into the chromosomes of a cell - so that it possessed a healthy copy of the human "gamma c" gene that Rhys lacked. Scientists connected a bag containing the genetically modified virus to a bag of Rhys' bone marrow. The hope was that the virus would mingle with the bone marrow cells and inject the healthy gene into the stem cells. Mingling completed, the doctors then transfused the marrow back into Rhys last year in a painless procedure simuar to a blood transfusion. There was then an agonising period when both parents and doctors waited to see if it had worked. By Christmas, the toddler was showing signs of getting well. Two months later, his lymphocyte count shot up to almost normal levels. For the fint time in his short life, Rhys was able to start mixing with other children and playing outdoors. Thrasher said: "Rhys has a normal immune system. He's thriving, he's normal. We were enormously relieved. We were ecstatic. We've been working on gene therapy for many years in the laboratory and ft's great to be able to take that work into the clinic and see some therapeutic success." The first gene therapy trial took place in the United States in September 1990. Since then about 500 trials worldwide have been done - with little success. Although there are risks with gene therapy, Thrasher believes it is safer than conventional bone man-ow transplants which often involve chemotherapy. "The procedure is incredibly safe. We've seen no side-effects at aR in either ofthe patients. The risk of cancer resulting from conventional chemotherapy is probably a lot higher," Thrasher said. A second 10-month-old child with SCID also had gene therapy at Great Onnond Street four months ago. The patient is doing even better than Rhys at a comparable stage. Thrasher said Great Or-rnond Street has applied to the Gene Therapy Advisory Conunittee for permission to conduct further trials on other conditions. "In principle, it meahs we can extend type of therapy to other blood diseases and that's going to be hugely important for many of our patients who don't have bone mattow

donors." - INDEPENDENT

Hashmi decision sparks ethics row Friday, 22 February, 2002, 23:06 GMT
Treatment begins at a Nottinghamshire hospital The landmark decision to give the Hashmi family permission to use IVF treatment to help their three-year-old son has divided scientific opinion and angered "pro-life" campaigners.

Leading fertility expert Lord Robert Winston, director of research and development at London's Hammersmith Hospital, disagrees with the decision because of the risks involved.

He said: "I don't think it's right for couples to have their hopes greatly raised by this procedure when there are other techniques which might prove a lot more effective.

"If stem cell research is jeopardised because of an adverse public reaction to this case it would be most unfortunate.

"I'm quite concerned about this ruling and I don't think this was the right decision, but that is a personal view."

But Professor Vivienne Nathanson, head of ethics at the British Medical Association, welcomed the decision and denied it was a green light for "designer" babies.

She told BBC News: "It's a tiny step down that line but it's the kind of step that I think very many people will support.

"Most people feel alienated by the idea of a designer baby where you choose the eye colour or the hair colour, or something really rather flippant and unimportant.

'Exploitation'

"But the idea that the child may be able to be a donor to an older sibling is rather different, and particularly if you can use blood from the umbilical cord, which poses no risk of pain or discomfort or anything else to the newborn child."

Professor Nathanson said the fear of treating children as a "commodity" was an important consideration.

"Is this a wanted child or is it a child that's only wanted as a donor to the older child?

"If it's wanted for itself and [will] be loved and cared for, regardless of whether it turns out to be a suitable donor, then most people will be comforted, but it's a difficult and fine balance."

Anti-abortion charity Life claimed this turned the newborn child into an exploited commodity and designer baby.

Life director of research Peter Garret said: "This case raises serious questions as to how far we should allow science to go.

"Should we allow a child to be manufactured in order to serve the medical needs of an older brother? Life's answer is an emphatic 'no'."

He added: "Children should be accepted and loved unconditionally.

"The procedure being considered here will allow a child to be born only on condition that he/she can supply bone marrow for an older brother."

Screening creates 'disease free' baby Wednesday, 27 February, 2002, 00:00 GMT
The child is now 18 months old and genetically "safe" A woman has chosen to have a genetically selected baby to ensure it does not develop early onset Alzheimer's disease which runs in the family.

The woman, who is 30 and has not been identified, may be unable to recognise or care for her daughter within 10 years.

She and her family carry a mutation which causes the onset of Alzheimer's disease before the age of 40.

However, the child, who is now about 18 months old, did not inherit the tendency to develop the disease.

Early onset Alzheimer's, a very rare condition, is defined as Alzheimer's - a form of dementia - that strikes before the age of 65.

Researchers at the Reproductive Genetics Institute of Chicago said the baby's birth marked the first time preimplantation genetic diagnosis, as the technique is called, has been used to weed out embryos carrying the defect that causes early onset Alzheimer's.

The little girl is thriving, said Yuri Verlinsky, chief author of the report in this week's Journal of the American Medical Association.

Verlinsky said genetic screening has been used more than 3,000 times and is often employed to avoid inherited disorders like sickle cell anaemia.

His clinic was involved in a case last year where an embryo was chosen to provide stem cells to assist a sibling of the unborn child.

Ethical debate

While the child's mother is still healthy, her sister developed early onset Alzheimer's at the age of 38, her father died at 42 after suffering psychological and memory problems and one of her brothers began having short-term memory problems at 35.

He said: "I can't speak for the public, but it's a decision of the family and not the public."

In a commentary published in the same journal, Dena Towner and Roberta Springer Loewy of the University of California said the study raised ethical questions.

They said: "Much like her sister, the woman in the report ... most likely will not be able to care for or even recognise her child in a few years."

The two doctors said the mother acted responsibly by ensuring that her child will not have to live with the threat of developing early onset Alzheimer's.

However, they took issue with defining her ethical responsibility "solely in terms of disease prevention" without considering that she may not be able to care for her child.

"The differences between these two interpretations of ethical responsibility are stark, but both rest on assumptions made about reproduction - is it a privilege or it is an unquestionable and inalienable right?" they asked.

Mice Clones Cast doubts on Safety NZ Herald 2002
WASHINGTON Japanese researchers who cloned a dozen mice reported yesterday that nearly all of the animals died early. Their report casts more doubts on the safety of cloning. It also suggested that the technique used to clone an animal can have an impact on its ability to live a normal lifespan. "The possible negative long-term effects of cloning, as well as the high incidence of spontaneous abortion and abnormal birth of cloned animals, give cause for concem about attempts to clone humans for reproductive purposes," Atsuo Ogura and his colleagues at the National Institute of Infectious Diseases in Tokyo reported in Nature Genetics. The United States Congress is considering several bills aimed at banning human cloning. Two would allow research to continue as long as no baby was created, and a third would ban the use of all cloning technology to make a human embryo. Labs that have cloned animals have reported that the cattle, sheep and goats that make it to adulthood are normal in every way that can be measured. One big glitch has been in Dolly, the sheep that was the fint cloned from an adult in 1997. She has developed early arthritis, which her creators say could be bad luck or could be some result of the cloning process. Ogura's team reported on 12 male mice they cloned that looked normal at birth, although certain liver enzymes, used to monitor liver activity, were abnormal. "The cloned mice started to die 311 days after birth, and 10 of the 12 cloned mice died before 800 days," they wrote. Mice born through natural mating and conceived using artificial fertilisation lived much longer. The cloned mice had abnormal livers, lungs and perhaps some immune system anomalies.

Two of the clones are still alive and might live normal lives. It might be that the genetic makeup of the clone's "parent" is key to healthy survival, the researchers said. They also noted that clones may be bom "old." Some clones have shortened telomeres, which are a kind of cap on the chromosome, the structures that carry the genes. Each time a cell replicates, the telomere cap frays a little and this process is believed to 1)16 associated with ageing. Technique could also be -important, said Tony Penny of Advanced Cen Technology in Worcester, Massachusetts, one of the groups trying to use cloning technology to make human embryos for medical uses. Penny, who was part of the @t group to clone mice, said the method used to make cloned mice is different to the method used io make larger animals such as Dolly. Dolly was made using electroftision. One sheep's egg had the nucleus taken out, and a cell from the mammary gland of another adult sheep was fused to it using a burst of electricity. The second cell's nucleus and its genetic material replaced the missing nucleus, and the egg grew and divided as if it had been fertflised by a sperm. To make mice, the Japanese team microinjected the nucleus from the second cell into the egg. One method might somehow damage the tiny embryo, Penny and colleague Teruh*o Wakayama said in a commentary 6n the study. Or it could be the cytoplasm, the part of the cefl outside the nucleus, carries key factors for survival that are transferred with the electroftision method. Perry also noted that not all adult cloned animals were normal, and that most clones died at or before birth. REUTERS

IVF babies at risk of defects NZ Herald 2002

by Steve Connor in London

Babies born after in vitro fertilisation (IVF) are three times more likely to develop neurological disorders including cerebral palsy than children conceived naturally, a study has found. Scientists believe the findings could be explained by the complications that often arise when two or more IVF embryos share the same womb, rather than because of the IVF techniques themselves. Dr Bo Stromberg, who led the investigation at the University Children's Hospital in Uppsala, Sweden, said the findings supported the view that only one IVF embryo should be implanted mto a woman rather than the two or more routinely used in many countries.

"We think that IVF is a good treatment and a vital option for couples who can't have babies naturally, but we have to think of a baby's life, and not just that of the couple," Stromberg said. The study, which used Sweden's extensive health records, compared 5680 IVF children aged between 18 months and 14 years with 11,360 youngsters of the same age who were conceived naturally. Stromberg also compared twin births with single births. IVF in Sweden produces a relatively high number of twins because two embryos are routinely implanted into patients to raise the chances of a successful pregnancy. The scientists say in their report published in The Lame. "Our findings show that children bom after have an increased risk of needing treatment in d childhood disability centre. Our results can largely be, though not solely, explained by the high frequency of twins born, and by low bu-thweight and low gestational age, but an effect on the IVF procedure per se or other factors not adjusted for cannot be excluded." Twenty-three years have passed since the first test-tube baby was bom. Worldwide, there are about 50,000 IVF children born a year, yet next to nothing is known of any possible long-term effects on their health. The Swedish study was not big enough to discern any problems with the IVF techniques used, such as the direct injection of a single sperm into an unfertilised egg, or the effects of inducing the production of eggs in a woman. INDEPENDENT

Monsanto Markers Patent

[email protected]

BioDemocracy News #36 Food Fight in a Time of Crisis Nov. 2001 By: Ronnie Cummins, Organic Consumers Association www.organicconsumers.org

Monsanto, meanwhile, has tightened its stranglehold over the agbiotech and seed sector. The company in April was awarded a wide-ranging, controversial patent from the US Patent office on all antibiotic resistant marker genes (found in nearly all GMO crops), and continues to move forward to gain a similar monopoly patent on Agrobacterium tumefaciens, a vector (sort of a cellular taxi) used widely in gene-splicing. Monsanto is also requiring strict licensing and royalty agreements for scientists carrying out research on the genetic structure or genome of rice-for which the company holds a patent. (See www.rafi.org)

On the intimidation front, Monsanto continues to press legal charges against several hundred North American farmers for the "crime" of saving their seeds without paying a royalty payment to Monsanto. After gaining a precedent setting court conviction against Saskatchewan farmer Percy Schmeiser in March, unjustly accused of growing Roundup Ready canola which had actually drifted onto his fields from adjoining farms growing GE crops, Monsanto set up a toll-free "snitch line" in Canada, advertised on radio stations, for farmers to "turn in" their seed-saving neighbors. After protests the snitch line was disconnected. A similar snitch line was set up in the US several years ago.

Scientists detail rice code Rice: Thursday, 4 April, 2002, 19:30 GMT 20:30 UK
The world's most important cereal crop

By Jonathan Amos BBC News Online science staff

Scientists have laid bare the "life code" of rice.

Two groups of researchers report a draft DNA sequence of the plant - a staple for more than half the world's population - in the journal Science.

The genetic information should speed up the breeding of tougher and higher-yielding varieties that can help feed the world's burgeoning population.

The genomic data will also prove invaluable in boosting the productivity of the other grasses on which humans depend, such as maize (corn) and wheat.

The research shows that a rice plant probably has more genes than a human - perhaps as many as 50-60,000 genes, compared with our 30-40,000.

But the rice genome, like the gene sets of all plants, contains tremendous duplication. Something like three-quarters of all rice genes are repeated in the code.

Much duplication

Scientists think plants copy their genes and then modify them as a strategy for coping with the selective pressures associated with evolution.

The Beijing Genomics Institute and the University of Washington Genome Center, with colleagues at 11 Chinese institutions, read the code of the rice strain known as indica, the predominant subspecies in China and other Asian-Pacific countries.

The second team, fronted by the Swiss-based Syngenta company, decoded the japonica, or Nipponbare, subspecies, which is popular in more arid regions and, in particular, Japan.

The genetic difference between the two is small but significant - about a half to one percent variation in the code. This is about 10 times the variation you would find in the genetic codes of two humans.

Rice, known scientifically as Oryza sativa, is the second plant to be decoded. The first was the tiny mustard plant, Arabidopsis thaliana, used as a laboratory model to investigate plant biology.

Rice, however, is the first food crop to be sequenced.

Another method

Both teams used the Whole-Genome Shotgun technique, the same method employed by the private company Celera to read the human "code of life".

And just like Celera, Syngenta has struck a deal with the Science journal editors that ensures it keeps proprietorial control over the japonica sequence.

The code has not been deposited in a public database, GenBank, as is customary, but in an escrow account held by Science and a separate system run by Syngenta.

Researchers wanting to work on the sequence will have to sign usage agreements with the Swiss company. Critics claim the access restrictions go against the spirit of open research and will slow the advance of new knowledge.

A consortium of public laboratories, known as the International Rice Genome Sequencing Project (IRGSP), financed by Japan, is also sequencing the Nipponbare subspecies.

The consortium has opted to use a more systematic, traditional route to decryption which, though more precise, can take longer. The IRGSP is expected to publish its results later this year.

Genome dispute touches rice Thursday, 4 April, 2002, 19:29 GMT 20:29 UK
Syngenta wants protection from its competitors

By Jonathan Amos BBC News Online science staff

It seems genome announcements customarily come with a bit of a row attached - and so it is with rice.

The Swiss-based Syngenta company publishes an analysis of how it cracked the code of the japonica subspecies of the plant in the journal Science this week, but the data themselves will not be going into the publicly searchable GenBank depository.

Syngenta has refused to put its code in this international data pool because it wants to retain proprietorial control over the fruits of its hard work.

Instead, the data will be dropped in an escrow account controlled by Science and any researchers wanting to mine the code for their own studies will be allowed to do so on a Syngenta website or CD-Rom - provided they accept certain conditions.

Competitive advantage

The editors of Science did not want to do it this way but felt controlled access was better than no access.

It is a similar deal to the one Celera Genomics struck when it published details of its human DNA sequence in Science in 2001.

Syngenta said the deal would give public-sector researchers access to its work while protecting its commercial interests.

"If we were to put our material in GenBank it would be available to our competitors as well as to academicians," a company spokeswoman said.

"The academic community will have access through a CD-Rom... they will have to make a request via their university that they will use it for academic purposes and not commercial purposes."

Not for profit

Of course, not everyone sees it like that. When rumours of the Syngenta deal first started circulating, about 20 prominent geneticists, including two Nobel Prize winners, wrote to Science to complain.

Anything other than free and unrestricted access was damaging to the interests of science, they said.

They believe the access arrangements will make it virtually impossible for scientists to do meaningful research on the japonica sequence.

The agreement demands that any academic requiring more than 100,000 bases per day, per week must submit a letter signed by the researcher's institution to the company for approval first. This letter must state that the data will not be used for profit.

Dr Michael Ashburner, a geneticist at Cambridge University, UK, is scathing in his condemnation of the Syngenta deal.

'Public benefit'

"Offering you data in tiddly bits of 100 kb from a 400 Mb genome is stupid," he told BBC News Online. "If you want to know how many genes of a particular class are in the rice genome, you couldn't do it - not unless you sell your soul to Syngenta.

"Doing comparative genomics on the other cereals with this sequence is going to be very difficult. People, if they've got any sense, will either work on the indica (from the Beijing Genomics Institute) or they'll wait for the public sequence to come out of Japan."

Dr Ashburner said Science was being shortsighted and claimed rival journal Nature had now become the magazine of choice for researchers to make their genomic announcements.

But Donald Kennedy, Science's editor-in-chief, said the journal had found a creative way to marry the conflicting interests of private investment and open research.

"From my perspective, the question is whether the public benefit inherent in placing these valuable data into the public domain - rather than in trade-secret status - is greater than the cost associated with having the sequence data accessible through a private site rather than the publicly supported GenBank.

"We thought that was clearly true for the human genome sequence. For rice, the most important agricultural commodity in the developing world, the case is surely even stronger."

The indica sequence produced by the Beijing Genomics Institute and the University of Washington Genome Center has been put in GenBank.

Stem Cells may Cure Ailing Heart Apr 2002
Researchers have undertaken the first clinical trial of a break-through procedure.

SYDNEY Jim Nichol, 74, of Newcastle in New South Wales, a veteran of three bypass operations, is at the centre of a worldifirst trial using adult stem cells to repair his damaged heart. Researhers, from John Hunter Hospital in Newcastle revealed yesterday how on Monday they took bone marrow from Nichol's hip, extracted stem cells from the marrow and injected the cells into the muscle of his heart. If the experiment works the way they expect, the iwected stem cells will begin secreting growth factors which will stimulate the growth of blood vessels in Nichol's heart, easing his constant chest pain and reducing his need for medication. It was the fust clinical trial of a procedure that doctors hope could help almost a third of all patients with end-stage coronary artery disease. Cardiologist Suku Thambar of the Hunter Medical Research Institute's heart and lung research programma, said the procedure was directed at what were known as "no option patients".

"This is trial which is seeking to examine the eticacy 'of the patient's own adult bone marrow-derived stem cells to increase the blood vetsel growth in the heart," he said. "It involves a group of patients who have got vessels whichare not amenable to the conventional methods of improving blood supply, such as angioplasty or coronary artery bypass surgery."

Safety and feasibility studies were completed overseas. TWnbar said Nichol had been discharged from hospital yesterday in-a stable condition but it would be some months before it became clear wh&her the procedure was working. The trial follows news that a United States man has apparently recovered from Parkinson's disease after being iwected with stem cells ft-om his own brain. Because the procedures use adult stem cells, they are distinct from the more controversial use of embryonic stem cells, which are harvested from human embryos. Prime Minister John Howard said last week that embryonic stem cell research using surplus fVF embryos would proceed in Australia. Thambar said that although there were definite benefits in using adult stem cells, no decision had yet been made about whether embryonic stem cells would be used in later stages of the current trial. "Adult stem cells are readily available, they are from the patient's own body, [the procedure is] relatively simple and it's not controversial," he said. The experiment was overseen by Dr Samuel Fuchs of the cardiovascular research institute at the Washington Hospital Centre and Dr Phil Rowlings of the Newcastle Mater Misericordia Hospital. It used a high-tech cardiac imaging system to create a 3-D map of the heart which enabled the operation to be carried out with pinpoint accuracy. Further clinical trials are expected to take place in Hong Kong and China. other countries, including Italy, are expected to join later. AAP