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UK Government Funds MMR Study

The Department of Health has confirmed it is providing top-up funding for "ongoing" research into the measles, mumps, rubella (MMR) vaccine. Scientists at the National Institute for Biological Standards and Control (NIBCC) have been investigating Dr Andrew Wakefield's controversial claims of a link between the vaccine and Crohn's disease and autism. The new £300,000 funding from the DoH will ensure the work can continue for the next three years. Dr Wakefield sparked concerns over the MMR vaccine when he went public with his findings in 1998, but he began his research years earlier. The NIBCC has been following Dr Wakefield's work on Crohn's disease and autism since 1993. Scientists at the NIBCC are collaborating with the paediatric gastroenterology department at London's Royal Free Hospital, where Dr Wakefield worked. Part of the new research will involve an attempt to reproduce Dr Wakefield's results suggesting a link between MMR and autism. A Department of Health statement said: "This study is part of an ongoing programme of work. "Since 1996 NIBSC has been attempting to replicate research findings on the measles virus, bowel disorders and autism. The methods used at NIBSC are some of the most sensitive available. They have not been able to repeat these findings. "In February, Dr Wakefield was asked to provide his samples for analysis by other experts and he has yet to respond. This project brings together a range of experts including Dr Wakefield's collaborators from the Royal Free Hospital, who have agreed to provide some samples. "Our position remains that based on the best available scientific evidence MMR is the most effective way to protect children against measles, mumps and rubella."

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UK Autism Study Launched

By Philip Hunter British researchers have launched a major study into the effect of genetics and environment on autism, hoping to resolve controversies over the causes and definition of autism spectrum disorders. The Medical Research Council (MRC) has given a team from Bristol University £400,000 to study autism using data from the Children of the 90s study, a long-term project assessing the impact of environment and genes on the developing health of 14,000 children. Lead researcher Jean Golding said the study should resolve once and for all the controversy over the alleged link between the measles, mumps, and rubella (MMR) vaccine and autism that has rumbled on ever since Andrew Wakefield's famous Lancet paper and subsequent press conference in 1998. In fact, the project is one of four into autism supported by the MRC from funds that were allocated to take forward recommendations of the 2001 MRC Review on Autism, which was partly a response to concerns raised by Wakefield. The other three projects include a collaborative brain imaging study, led by Declan Murphy at the Institute of Psychiatry, King's College London, and studies led by Kate Nation, at the University of Oxford, and Tony Charman, at the Institute of Child Health, to understand more about how cognition relates to behavior in people with autism spectrum disorders. The Bristol study was welcomed with some caveats by Paul Shattock from the UK Autism Research Unit in Sunderland. "There's a whole range of possible environmental triggers, and given the size of this study, they should be able to tease out which ones are significant," Shattock said. "So I'm pleased they're moving away from a totally genetic grounding to consider environmental factors." Shattock urged the study's researchers to keep an open mind over the alleged MMR link, but said he was not convinced that even a study this size will finally resolve the MMR question. Given that the incidence of autism is about 1 in 140, and that of these children, around 7 to 11% have parents believing there is such a link, there might be no more than 10 of them within the 14,000 sample, Shattock said. Golding insisted the team will assess the possible MMR link with an open mind. "But I'd be surprised if it turns out there is a link," she said. Golding said she hoped the study would help define autism and Asperger syndrome. "What this research is doing, that previous work hasn't, is try and untangle the different traits." The study is also focusing on the possible links between autism and gut bacteria passed from mother to child during pregnancy, although only via indirect data on the state of the mother's bowel movements, according to Golding. But one question the study will not be able to answer is whether the incidence of autism has been increasing over the last 30 years, as is commonly believed, or whether improved diagnosis is the reason for greater patient numbers. "I don't think we'll be able to answer that because our study is a snapshot in time," said Golding. The study was called a positive step forward by the UK National Autistic Society. "However, until the outcomes of these new research studies are seen, the significance of their contribution to understanding the development of autism will remain undetermined," said Stuart Notholt, the society's director of policy and public affairs.

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U.S. to Launch Massive Study Into Children’s Health

Angela Pirisi for HealthDay Health Day News - Researchers have long wondered about the role environmental factors play in rising rates of childhood ills such as asthma, obesity, autism, learning disabilities and schizophrenia. The National Children's Study aims to tackle that question as it takes a hard look at what risks kids are exposed to in their environment from the moment they're conceived right through to early adulthood. The goal: To help pinpoint the root causes of many of today's childhood and adult diseases and disorders. The longest, largest study of children's health and development ever conducted in the United States, it will begin in 2007 under the auspices of the U.S. Department of Health and Human Services and the Environmental Protection Agency. "While new policies will come of it, this study data will also provide guidance for health-care providers to counsel patients on how to avoid or reduce risks of exposure," said Dr. Peter Scheidt, program office director for the National Children's Study at the National Institute of Child Health and Human Development. The study will monitor an estimated 100,000 children and their families from before birth to age 21, to better understand the link between the environments in which children are raised, and their physical and emotional health and development. The findings are expected to influence the well-being of children for years to come, the researchers said. But health experts won't have to wait more than two decades to reap benefits from the study, Scheidt said. "Outcomes of pregnancy will be available first -- likely the first findings will be out by 2009 or 2010," he said. Doctors already know what diseases and conditions are assaulting the nation's children, said Dr. Michael Shannon, chairman of the American Academy of Pediatrics' Committee on Environmental Health. "We know quite a bit," Shannon said. "Recent research shows that the development of children's lungs is impaired by their exposure to air pollutants. We're aware of the harmful effects of lead, mercury, arsenic and environmental tobacco smoke in the environment. And then there's the increasing concern, based on experimental data, about phthalates, PDBEs, pesticides and other ubiquitous environmental pollutants." Other studies have been much smaller in size and scope, capturing just a snapshot of a short period in early life stages. "This study will enable us to look at multiple measures of risk exposure factors that lead to the same disease outcomes," Scheidt said. That also means being able to gauge the effects of exposure to several chemicals simultaneously, or the interaction between genetic predisposition to a disease and environmental influences. "For example, we know that 50 percent of schizophrenia cases are determined by genetics, but the other 50 percent stem from environmental causes. By examining those environmental influences, we could potentially prevent half of the cases," explained Scheidt. Shannon said: "Obesity is attributed not only to changes in the American diet but increased reliance on automobiles, which has reduced the activity level of children. And an estimated 17 percent of American children have a developmental disorder, which is being caused or exacerbated by environmental agents." The study will be conducted at 96 locations across the country, enrolling at least 250 newborns a year for five years from each site. It will include pregnant women and their partners, couples planning pregnancy, and women who are of childbearing age but aren't planning a pregnancy to track the children born to those women. "This study is unprecedented, and it will yield a tremendous amount of new information on what agents in the environment affect children, based on the agent, the extent of the exposure, the timing of exposure, the specific susceptibility of the child and even exposure issues in pregnant women," Shannon said.

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U.S. Will Pay For Study To Seek Cause Of Autism

By Anita Manning, USA Today A major U.S.-financed study designed to unearth the roots of autism will track 100,000 babies in Norway to identify biological and environmental factors that could combine to cause autism and other developmental disorders. The Autism Birth Cohort, led by researchers at the Mailman School of Public Health at Columbia University, will follow kids and their parents for five years, beginning during the mother's pregnancy. Ultimately, the work could produce the kind of information on risk factors for developmental disorders that the landmark Framingham Heart Study did for stroke and heart disease, says W. Ian Lipkin of Columbia, the autism study's lead investigator. Researchers will collect information on exposures to toxins, including mercury, which has been suspected as a factor in autism, as well as diet, vaccines, babies' birth weight and head circumference, and volumes of other data that can be analyzed to compare children who develop autism with those who do not. The causes of autism have long baffled investigators and frustrated parents. The mystery has led to wide speculation that childhood vaccines, viral infection or environmental toxins play a role, though scientific evidence has not been conclusive. The new study, outlined at a meeting at Columbia University on Monday, is being conducted within a larger project instituted by the Norwegian Institute of Public Health. That initiative began recruiting pregnant women in 1999 for a long-range study to track a variety of childhood and adult diseases. Women are enrolled at the time of a prenatal ultrasound, usually at 17 weeks gestation. Mothers and fathers answer questionnaires on their health habits and nutrition, and blood samples are taken periodically from parents and child. As of January, 33,656 babies had been enrolled, along with their parents. The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, will provide $13 million over five years for the autism project, says program director Deborah Hirtz. A similar study is planned in the USA, she says, but it's just in early discussion stages. By partnering in the Norwegian study already in progress, the project can begin gathering and analyzing data right away, Lipkin says. He expects the first significant data to be available as early as next year. "We will potentially reveal all sorts of interactions between the environment and genes," he says. The main focus is on autism, but "ultimately we'll be looking at disorders like ADHD (attention deficit hyperactivity disorder), dementia" and more, he says. Scientists believe autism and related conditions grouped under the name Autism Spectrum Disorder result from a genetic predisposition triggered by some as-yet-unknown environmental exposure. Infections or exposure to certain substances before or shortly after birth may result in diseases that appear later, Lipkin says. Timing of such exposures may also play a role, he says. The study's design allows scientists to "look during gestation, where some of the roots (of autism) may appear," Lipkin says. "If we can find what puts kids at risk, we can develop interventions," including medications or behavior changes.

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U-M leading national effort to find the cause of autism

ANN ARBOR, Mich.- University of Michigan researchers are leading an 11-university consortium to gather and bank DNA samples from 3,000 autism patients over the next three years. The Simons Simplex Collection Autism Research Initiative, expected to cost $10 million over its first two years, is being spearheaded by Catherine Lord, director of the U-M Autism and Communication Disorders Center. The consortium also includes: Yale University, Harvard University, Boston University, Columbia University, Washington University, the University of Washington, the University of Illinois-Chicago, Emory University, McGill University in Montreal and the University of California, Los Angeles (UCLA). "It's an exciting opportunity," Lord said. "Collecting this data will greatly speed up the process of finding the causes of autism." The Simons initiative, begun by billionaire money manager Jim Simons and his wife, Marilyn, was set up with the goal of investing $100 million toward finding a cure for the developmental disorder. The Center for Disease Control estimates that between one and three of every 500 children contract some form of the disease. While there are core deficits that define Autism Spectrum Disorders (ASD) there is also a great deal of heterogeneity among children and adults with ASD in terms of behaviors, level of functioning and co-morbid conditions such as mental retardation or obsessive compulsive disorder. Recent findings in the molecular genetics of autism and in family transmission patterns suggest that there are likely several, if not many, autisms. Researchers say it is important to identify subtypes of autism that are associated with risk factors or etiologies in order to develop appropriate treatments or prevention strategies. The Simons Initiative to create a collection of simplex (families with just one child with autism) is aimed to support research across a range of areas with an adequate sample to address different sub-types. The Simons Initiative consists of both senior and junior investigator support as well as the creation of a bank of cell lines and phenotypic data that will be available for scientists around the world. The concept of a publicly available (through application by scientists) databank builds on the example of the Autism Genetic Recourse Exchange (AGRE), created by Cure Autism Now several years ago as well as large scale research projects such as the Women's Health Initiative. The Cure Autism Now effort focused on families where two or more siblings have autism but the 11-university effort will tackle the 90 percent of autism cases where the patient is the only member of the family with autism. Families will be recruited to participate in an initial assessment and then invited into other research projects as work continues. The Simons Initiative will be carried out in existing university-based clinics by individual investigators from different universities throughout North America. The goal is to collect well-defined, carefully characterized samples of families with one child with Autistim Spectrum Disorder and at least one typically developing child. Lord, a nationally known pioneer in autism research, played a key role in learning how to properly diagnose two-year-olds a decade ago and is making new gains diagnosing young children at the U-M center. While medications have helped with related conditions such as depression and hyperactivity, the best way to deal with autism is to intervene as early as possible to treat the condition, she said. Children who developed even some very simple speech skills prior to the first time they were evaluated at age two were far more likely to overcome the disorder that is now found in one out of every 200 children, she said. Autism is a complex developmental disability that typically appears during the first three years of life. Autistic spectrum disorders impact the normal development of the brain processes related to social interaction and communication skills. Children and adults with autism typically have difficulties with verbal and non-verbal communication, social interaction and leisure or play activities. For more information about participating in the research studies, call the center at (734) 936-8600.

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Tsunami Families with Autism

From an announcement by Unlocking Autism We are sure that you are as saddened as we are viewing the devastation that has taken place around the Indian Ocean area of our world. The loss inlives as well as material necessities is unbelievable. At Unlocking Autism our hearts go out to the parents of children with autism in those affected areas whose world is even more confused because ofthe lack on continuity and stability. The autism community is worldwide and does not know the boundaries of the borders of the United States. To this end we are encouraging our community to reach out with the generosity that we have seen in the past and in a concerted effort,together, make donations that will be directed specifically to the children with autism and their families in Indonesia. Unlocking Autism has two UA Representatives in Jakarta, Indonesia who have volunteered to find parentsof children with autism whose families were specifically affected by the earthquake and tsunamis and direct the funds raised to them to help themmore quickly rebuild their lives. The National Autism Association is joining us in this effort. If youknow of a specific family in this region that was affected, please writeNancy Cale at NANCALE@aol.com. Otherwise, please stay tuned for forthcoming information on how you can help these families. Once we have been able to find them we will send out a call to you for help. [Editor's note: we have some readers from that part of the world and subsequently they will get this message. -LS]

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Trust me, I’m a Junior Doctor

Under-Informed Patients Should Stop Trying To Heal Themselves By Max Pemberton. This commentary is excerpted from an essay in the Telegraph, UK. I remember being struck by common, complications of infection with measles, mumps and rubella. Clinical meningitis, for example, occurs in a staggering five per cent of all patients infected with mumps. And the list goes on and on. These three diseases are serious, and yet up and down the country parents have been declining to have their children immunised against them. This was due to the paper published in the Lancet in 1998 that claimed to have found a link between the jab and autism. Despite repeated attempts to reproduce the research and in-depth epidemiological studies, no link has been found and the work has now been discredited in a Cochrane review, which combines the results from high-quality controlled trials. But still parents refuse to have their children immunised. It's not out of stupidity. In fact, in my experience, it is the educated parents who still refuse. The information that was presented to them in the media was convincing. It is easy to get drawn in by statistics, particularly when you only have the briefest understanding of the subject. The irony of our complex relationship with medicine was evident last week when it was announced that there were fears that the UK may run out of vaccinations for 'flu. This was blamed on the "worried well" - middle-class, well-educated, sensible people who read newspapers and understandably panic that we are all going to die of bird 'flu. What people failed to realise is that the vaccination isn't anything to do with bird 'flu, or even the pandemic influenza viruses that occasionally rear their heads. It is to do with the standard 'flu virus. This is the same virus that kills thousands of frail and old people every year. When it comes to health, there is a tendency to panic. But often, this is not directed at the things that we should actually be panicking about. The same people who refused to have their children immunised with MMR are now hammering to get the 'flu jabs. But they miss the point. There has been one doubtful research paper linking MMR and autism versus the many very real complications of measles, mumps and rubella; everyone worries about autism. But the real risk to public health has been the refusal of parents to have their children vaccinated, not the development of autism. And the real risk to lives will be a shortage of influenza vaccine, not avian 'flu. The "worried well" are not to blame; they are worried because they are told to worry. Research is complicated and, often, in boiling it down to a few easily digested sound bites, the full complexity and meaning of the information is lost in the media. It is worth remembering that sometimes a little bit of knowledge can be far more dangerous than the very crisis it concerns.

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Trials End Parents’ Hopes for Autism Drug Secretin

By Andrew Pollack for the New York Times For several years, an experimental drug, secretin, has offered an unlikely ray of hope for some desperate parents of children with autism. Discovered accidentally by the mother of an autistic boy and licensed to a small biotechnology company led by the father of two autistic girls, secretin has advanced through clinical trials even as study after study showed it had little or no effect. Now, the largest and most definitive clinical trial of secretin has been completed, and it, too, showed that the drug was no better than a placebo in improving the social interaction of young children with autism. The failure, announced yesterday by the company, Repligen, of Waltham, Mass., casts doubt on whether secretin will ever get to market as a treatment, dealing a blow to scores of parents and some doctors who advocated its development. "We're horrified at the thought of this being dropped," said Jan Henry of Chattanooga, Tenn. The drug, which Ms. Henry said she bought from overseas sources and others at up to $10,000 a year, had helped her son Andrew speak and sleep. "It's life to us," she said. "My parents mortgaged their home for us," she added. The secretin story shines a light on the difficulty of developing a drug for autism, an often debilitating condition whose incidence seems to be rising sharply and for which there are no approved drugs. Experts estimate that the United States has more than 100,000 autistic children. Children with the condition have difficulty communicating or forming relationships, and they often have repetitive actions. The development of the drug has at times been a battle between the hopes of parents and the more dispassionate science of some experts. Some advocates say the experts too easily dismissed the drug because it was developed outside conventional academic channels or drug companies. "This is the type of thing you see all the time in medicine, where things that get strong patient and parental advocacy and don't come through the normal channels of discovery get dismissed," said Dr. Jeff Reich, a neurologist and senior analyst at Merlin Biomed, an investment fund in New York that owns shares of Repligen. Some experts say that parents see what they want to see and that the drug simply does not work when measured more objectively. "We now have multiple, multiple studies showing secretin is not better than placebo," Dr. Fred R. Volkmar, a professor of child psychiatry at Yale, said. "I would say it's time to shift our attention elsewhere." Secretin is a natural hormone that stimulates the pancreas to release juices that aid digestion. A synthetic version is approved for use in diagnosing pancreatic disorders. In 1996, Parker Beck, an autistic boy in New Hampshire, was given secretin to help diagnose gastrointestinal problems, which afflict many children with autism. His mother, Victoria Beck, soon noticed an improvement in his development and began to suspect the secretin. When the Becks tried to obtain more treatments for Parker and his medical records from the University of Maryland, where he had the diagnostic procedure, they were rebuffed, Mrs. Beck said. The family then learned that the university was applying for a patent on using secretin in autism. When the Becks told the university their history, the university listed her as an inventor and assigned her the patent rights. She in turn licensed them to Repligen, whose president, Walter C. Herlihy, has two autistic daughters. The news was reported on television and in newspapers in 1998 and 1999 and led to a flurry of interest in secretin. Some parents obtained the version for pancreatic disorders. Some ordered it from overseas. But some small studies sponsored by the National Institutes of Health showed that secretin had no benefit beyond that from placebos. Repligen conducted a larger trial that involved three doses. That test was also not convincing but the drug seemed to show some effect in younger children. The company began a Phase III study, usually the last stage before regulatory approval, involving 132 younger children, from 2 years 8 months to 4 years 11 months, who were given six doses each intravenously. The results announced yesterday showed that the recipients of the drug did not improve more than those who received the placebo when evaluated by parents or psychologists. Repligen stock lost more than 40 percent of its value, dropping $1.77, to $2.39. "It's a sad day," Dr. Herlihy, the chief executive, said in an interview. He said the company would decide whether to keep developing the drug for autism after further analyzing the data and conferring with the Food and Drug Administration in the coming months. But Dr. Herlihy and some doctors in the trial are not ready to concede. They said one reason that the trial might have failed is that it is difficult to measure improvements in autistic children. The drug did show an effect for a subset of children with higher I.Q.'s. Also, the term "autism" probably covers a wide range of conditions. Secretin may work for some patients, but the effects would be diluted in testing on a broad population. "I remain convinced there's a subset of children who benefit from secretin," said Dr. Paul Millard Hardy, a behavioral neurologist in Hingham, Mass., in the trial. One of his patients, Jeremy McGlone of Kingston, Mass., was in the trial. Jeremy's father, Shayne McGlone, acknowledged that he did not know whether his son received the drug or the placebo, although he speculated that it was the drug. "He started looking at me in the eyes a lot more," Mr. McGlone said. "As a father, that's something you want your kid to do." Parker Beck, 10, has improved greatly and no longer takes secretin, his mother said. Anticipating royalties from secretin sales, Mrs. Beck and her husband, Gary, set up the National Autism Outreach Foundation last summer in Highlands Ranch, Colo. But now the royalties will apparently not arrive. "We'll find other ways to raise

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Trial To Test Link Between Autism And Gut Disorders

By Clive Cookson, Science Editor The theory that some symptoms of autism are caused by problems in the gut will be put to the test later this year, when scientists begin clinical trials of probiotics - "friendly bacteria" - in autistic children. Glenn Gibson, professor of food microbiology at Reading University, said yesterday that studies of 210 children with autism in the US and UK showed exceptionally high levels of harmful bacteria, known as clostridia, in their guts. Those with brothers or sisters had much more clostridia than their siblings. "We are now screening several strains of probiotic bacteria to see which will intervene against these clostridia," said Prof Gibson. "Human trials will start later this year using the probiotic which performs best." Although the link between autism and gut disorders is scientifically controversial, he has no doubt that autistic children do have bowel abnormalities. The nature of the association is uncertain. Prof Gibson's theory is that the "gut flora" fail to develop normally during early childhood, allowing clostridia to take hold. These bacteria produce toxins that may damage the brain, contributing to the characteristics of autism. "But it is just a hypothesis at this stage," he emphasised. The trial - to be carried out jointly with Frimley Children's Centre in Hampshire - will involve 50 to 70 children with autism aged five to eight, who will be divided into two groups. One will receive daily drinks containing probiotic bacteria and the other will receive placebos. The groups will be monitored to see whether the probiotic bacteria suppress harmful clostridia and if this produces any psychological changes. Prof Gibson was speaking at the launch of Proviva Shot!, a probiotic drink, although his research will be conducted independently.

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Training Parents Aids Autistic Kids’ Language

By Amy Norton for Reuters Health Training parents to better communicate with their autistic preschoolers can spur children's language development, according to a study of one such training program. Though parental training courses are a growing part of managing autism spectrum disorders, there has been little evidence from clinical trials that the approach aids children's language, behavior and social skills. "The evidence base has been very limited, so our study is a major contribution," Dr. Helen McConachie, of the University of Newcastle in the UK, told Reuters Health. Specifically, she and her colleagues found that a program known as More Than Words helped parents build their 2-, 3- and 4-year-old children's vocabularies. The program, which was developed by Canadian doctors, teaches parents how to interact with their autistic children in a playful way-using "fun" words, games, musical speech and other tactics to aid their language development. The findings are published in the Journal of Pediatrics. Autism spectrum disorders refer to a group of developmental impairments that includes autism and a milder disorder called Asperger syndrome. All of the disorders involve varying degrees of impairment in communication, social interaction and behavior. In more severe cases, children may speak very little and use single words rather than sentences. They also often have trouble reading other people's non-verbal "cues," like facial expressions, body language and tone of voice. Parents in the current study attended a weekly, 20-hour training course that taught them to interact with their preschoolers in particular ways designed to spur language development. Parents trained together in small groups, the researchers note, which allowed them to give each other support and share experiences. McConachie and her colleagues compared 26 parents who went through the course with another group of 25 parents who had not yet attended. Seven months into the study, children in the program had a larger vocabulary overall than those whose parents had not gone through the course. In observations of the parents, the researchers found that those who went through training were more likely to use language-building "strategies," such as simple language, attention-grabbing words, praise and games. Though the study was small, McConachie said it was larger than most previous studies of early interventions for autism and, unlike many studies, included a comparison group where parents had not yet received training. That makes it more likely that the children's language gains were sparked by their parents' training, according to McConachie. She noted that the first large-scale clinical trial of such training -- the Preschool Autism Communication Trial -- is set to get underway in the UK next year. SOURCE: Journal of Pediatrics, September 2005.

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