25 Март, 2003
Repligen Announces Open Label Extension of Phase 3 Clinical Trials of Synthetic Human Secretin in Children with Autism
WALTHAM, Mass., March 25 /PRNewswire-FirstCall/ -- Repligen Corporation announced today plans to initiate an open label extension of its ongoing Phase 3 clinical trials of synthetic human secretin in children with autism. PR via NewsEdge Corporation : WALTHAM, Mass., March 25 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today plans to initiate an open label extension of its ongoing Phase 3 clinical trials of synthetic human secretin (RG1068) in children with autism. In the extension phase of the study, all patients who complete the Phase 3 trials will be offered the option of treatment with RG1068 once every three weeks for 1 year. The goal of the Phase 3 Extension Study is to provide patients access to RG1068 and to collect additional, longer-term safety data. Each patient will be monitored for Adverse Events and changes in a variety of blood parameters throughout the Extension Study. "We are pleased to receive approval from the FDA for this open label extension of our Phase 3 clinical trials which was initiated at the request of some of the clinical investigators in our study," stated Walter C. Herlihy, President and CEO of Repligen. "This study will provide patients, including those who may have received the placebo in the Phase 3 study, access to RG1068 prior to the completion of the Phase 3 study." Data from the Phase 3 Extension Study will add to the extensive safety data already collected in the Phase 2 clinical trial, the Phase 2 Extension Study and the on-going Phase 3 clinical trials. To date there have been more than 1,000 administrations of RG1068 in children with autism without a serious adverse event. Extensive analyses of blood and urine chemistries have shown no indication of toxicity associated with administration of RG1068 and no patient has developed an antibody response to RG1068. About Repligen's Phase 3 Clinical Trial of RG1068 Repligen is currently enrolling children aged 2 years 8 months to 4 years 11 months with moderate to severe symptoms of autism into two Phase 3 clinical trials. Each patient is comprehensively evaluated at baseline, receives six injections of RG1068 or a placebo over 18 weeks, and is then reevaluated for improvements in the symptoms of autism. The primary endpoints for the trial are improvements in reciprocal social interaction as measured with the Autism Diagnostic Observation Schedule and the Clinical Global Impression of Change. Secondary endpoints include improvements in language and improvements in behavior. The trials are currently being carried out at approximately 20 medical centers in the United States. Information concerning participation in the Phase 3 clinical trials may be found on www.autismtrial.com. About Repligen Corporation Repligen Corporation is a biopharmaceutical company committed to being the leader in the development of new drugs for pediatric developmental disorders including autism, immune and metabolic disorders. Repligen has a Specialty Pharmaceuticals business comprised of rProtein A(tm) and SecreFlo(tm), the profits from which will be used to support the development of our proprietary products. rProtein A(tm) is a consumable reagent used by the pharmaceutical industry to produce a class of drugs called monoclonal antibodies and SecreFlo(tm), secretin for injection, is marketed to gastroenterologists for pancreatic assessment and for use during a gastrointestinal procedure called ERCP. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from www.repligen.com. This release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance, management's strategy, plans and objectives for future operations, clinical trials and results and product plans and performance such as the anticipated growth in the monoclonal antibody market and projected growth in product sales, constitute forward-looking statements. Such forward- looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein. Walter C. Herlihy, Ph.D. President and Chief Executive Officer (781) 250-0111, ext. 2000 David Walsey EURO RSCG Life NRP (212) 845-4257 SOURCE Repligen Corporation -0- 03/25/2003 /CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen, +1-781-250-0111, ext. 2000; or David Walsey of EURO RSCG Life NRP, +1-212-845-4257/ /Web site: http://www.repligen.com/ (RGEN) CO: Repligen Corporation ST: Massachusetts IN: MTC BIO SU: EO-CR -- NETU005 -- 0765 03/25/2003 07:59 EST http://www.prnewswire.com <> << Copyright ©2003 PR Newswire >>
25 Март, 2003
Painkillers against alzheimer's disease
Scientists at the University of California have discovered that common painkillers may help dissolve the brain lesions - known as amyloid plaques - that are a hallmark of Alzheimer's disease. Scotland on Sunday via NewsEdge Corporation : Scientists at the University of California have discovered that common painkillers may help dissolve the brain lesions - known as amyloid plaques - that are a hallmark of Alzheimer's disease. Non-steroidal anti-inflammatory drugs, such as Ibuprofen, bind to these amyloid plaques, helping to destroy them and prevent the growth of new plaques. According to the researchers, this may explain why people who take anti-inflammatory medication over several years seem to be at lower risk for later development of Alzheimer's disease. In a separate study conducted at both Columbia University College of Physicians and Surgeons and Stanford University, doctors found that malfunctioning brain cells, called astrocytes, may be the culprits behind the accumulation of the amyloid proteins that cause plaque to form. Everyone makes this substance, but in people with Alzheimer's disease, the production process goes haywire. They either make too much or too little, or the substance itself is degraded. As a result, the proteins clump up, forming plaques, which then lead to the death of neutrons and dementia. Alzheimer's disease often begins with mild memory lapses, after which memory, language and most mental functions gradually deteriorate. Researchers at the London School of Economics say the number of people with cognitive impairment will rise by about 66 per cent. This shows a clear need to find widely available treatments that will delay the progression of dementia. Wouldn't it be great if the answer was already lurking at the back of your medicine cabinet? For more information, contact the Alzheimer's Society, Gordon House, 10 Greencoat Place, London, SW1P 1PH (020 7306 0606; enquiries alzheimers.org.uk) Publication: Scotland on Sunday Distributed by Financial Times Information Limited <> << Copyright ©2003 Financial Times Limited, All Rights Reserved >>
24 Март, 2003
Диссертации:

на заседании диссертационного совета НЦПЗ РАМН состоялась защита кандидатской диссертации

 

Состоялось представление к защите кандидатской диссертации Волель Б.А.

18 Март, 2003
First treatment in nine years approved for bipolar mania in Canada - Zyprexa(r) helps control the symptoms of mania and prevents relapse
TORONTO, March 18 /CNW/ - Today, Eli Lilly Canada Inc. announced that Zyprexa has been approved in Canada for the treatment of manic and mixed episodes associated with bipolar disorder, also known as manic depressive illness. Canada Newswire English via NewsEdge Corporation : TORONTO, March 18 /CNW/ - Today, Eli Lilly Canada Inc. announced that Zyprexa(r) (olanzapine) has been approved in Canada for the treatment of manic and mixed episodes associated with bipolar disorder, also known as manic depressive illness. Zyprexa is the first treatment in nine years approved for bipolar mania in Canada. Zyprexa provides rapid symptom control of a broad range of symptoms associated with mania and helps prevent relapse back into mania. "Zyprexa represents a significant advancement in the treatment of bipolar disorder," explains Dr. Roger McIntyre, Assistant Professor of Psychiatry at the University of Toronto. "A recent study showed that Zyprexa works better than Lithium, the current gold standard, in preventing manic episodes. In addition, ongoing studies show that Zyprexa manages both the manic and depressive phases of the illness." Bipolar disorder affects approximately one to two per cent of the adult population.(1) Bipolar disorder is a lifelong illness characterized by disruptive swings in mood--from euphoria and irritability (manic episodes), to periods of depression. A patient may experience either "pure" episodes (manic or depressive symptoms) or "mixed" episodes (a mixture of manic and depressive symptoms at the same time). In addition to the profound impact that the illness has on patients, there can be an equally severe impact on the patient's family and caregivers. Twenty-five to 50 per cent of people with bipolar disorder will attempt suicide at least once.(2) "When I'm in a manic phase my mind runs rapidly, I can't concentrate, I can become delusional and lose touch with reality. And in my depressed state nothing interests me. There seems no point in doing anything and everything seems too hard. It's overwhelming. Work is almost out of the question," explains Danny Marinus, bipolar patient. "It's awful for my family. They never know what mood I'll be in and what's going to happen next. Zyprexa has stabilized my mood and has helped me live a normal life again." "For patients, each day spent with manic or depressive symptoms can be devastating. Those afflicted with the illness suffer from severe mood swings to overwhelming feelings of sadness and low self-worth, which can include suicidal thoughts and even suicide," says Phil Upshall, President, Mood Disorders Society of Canada. "In addition to the profound impact that the illness has on patients, there can be an equally severe impact on the patient's family and caregivers. We welcome any new advancements that may help patients with bipolar disorder move forward with their lives." Clinical Trial Results In ongoing clinical trials with bipolar patients, Zyprexa has been shown to provide rapid symptom control, help patients remain in remission longer and help prevent relapse into mania: - Rapid symptom control in bipolar mania: studies show that Zyprexa demonstrated greater efficacy than placebo in the treatment of bipolar mania,(3,4) including a higher rate of response (65 per cent vs. 43 per cent respectively).(3) Zyprexa has been shown to produce a significantly greater improvement in symptoms of mania vs. divalproex(5) - Effective in depression symptoms: Zyprexa has been shown to manage depressive symptoms in patients with manic and mixed episodes. These symptoms are particularly resistant to standard anti-manic treatment. Nearly a seven-fold improvement in depressive symptoms was seen when Zyprexa was added to another mood stabilizer(6) - More effective than the current gold standard - lithium: a year-long study showed that in the maintenance treatment of bipolar disorder, patients taking Zyprexa relapsed into mania only half as often as patients taking lithium(6) Zyprexa is generally well tolerated. Adverse events reported in clinical trials included somnolence, dizziness and dry mouth, but rarely led to discontinuation of trial. As with other mood stabilizers, Zyprexa can also be associated with increased appetite leading to weight gain. The recommended beginning dose of Zyprexa to treat acute manic episodes is 10 milligrams in combination therapy or 15 milligrams by itself, taken once a day without regard to meals. Zyprexa is also indicated in Canada for the acute and maintenance treatment of schizophrenia and related psychotic disorders. Since introduced in 1996, Zyprexa has been prescribed to nearly 11 million people worldwide. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Eli Lilly Canada, headquartered in Toronto, Ontario, employs more than 700 people across the country. Additional information about Eli Lilly Canada can be found at www.lilly.ca. NOTE TO EDITORS: Physician experts will be available for interviews in Toronto, Hamilton, Vancouver, Montreal and Moncton. NOTE TO TELEVISION STATIONS: B-Roll will be available on March 18th at the following coordinates: 10:00 am - 10:30 am (ET) and 13:30 pm - 14:00 pm (ET) Anik E2 C Band, Transponder 3B, Audio subcarrier 6.2 and 6.8 Downlink Frequency 3820 vertical References 1. Mood Disorders Society of Canada website, http://www.mooddisorderscanada.ca 2. Jamison KR. Suicide and bipolar disorder. J Clin Psychiatry 2000; 61 (Suppl 9):47-51 3. Tohen, M et al., Efficacy of olanzapine in acute bipolar mania. Arch Gen Psychiatry 2000;57:841-849 4. Tohen M et al., Olanzapine vs. placebo in the treatment of acute mania. Am J Psychiatry 1999; 156:702-709 5. Tohen M et al., Olanzapine versus divalproex in the treatment of acute mania Am J Psychiatry 2002; 159:1011-1017. 6. Tohen M et al., Olanzapine versus lithium in relapse prevention in bipolar disorder: a randomized double-blinded controlled 12-month clinical trial. Presented at the Third European Stanley Foundation Conference on Bipolar Disorder in Freiburg, Germany. VIEW ADDITIONAL COMPANY-SPECIFIC INFORMATION: http://www.newswire.ca/cgi-bin/inquiry.cgi?OKEY=86406 -0- 03/18/2003 /For further information: Please contact: Kent Hovey-Smith, Eli Lilly Canada, (416) 693-3879; Sabrina Paiva/Michelle Muise, GCI Group, (416) 486-2560/(416) 486-7272/ CO: ST: IN: SU: CNW 08:00e 18-MAR-03 <> << Copyright ©2003 Canada NewsWire >>
17 Март, 2003
Схизофрения - Освальд Бумке

Схизофрения - Освальд Бумке

13 Март, 2003
Душевные болезни в картинах и образах - Зиновьев П.М
13 Март, 2003
Drugs And Driving Danger
The RAC Foundation has urged the Government to undertake an urgent investigation into the possible connections between road safety and taking anti-depressants and to highlight the potential of impaired driving performance to users of the medications. Nottingham Evening Post via NewsEdge Corporation : The RAC Foundation has urged the Government to undertake an urgent investigation into the possible connections between road safety and taking anti-depressants and to highlight the potential of impaired driving performance to users of the medications. The use of anti-depressants has increased dramatically over the past decade. Between 1990 and 1995, the number of prescriptions for anti-depressants rose by 116, and for SSRIs (newer anti-depressants such as Prozac) in particular by 732, 2001 alone saw a ten per cent increase on the previous year in the number of anti-depressant prescriptions. A recent report commissioned by the Department of Transport also suggested that more research was needed to investigate the effects of new-generation anti-depressants on driving performance and accident risk. It recommended that additional studies were needed - including the testing of drivers involved in road accidents for the presence of drugs at the time instead of the more traditional method of using prescription records. It reasoned that definitive conclusions could only be made following further studies that would also look at dosage, duration and tolerance levels and interaction with other drugs and alcohol. Edmund King, executive director of the RAC Foundation, said: "There has been an alarming increase in depressive illness and the number of prescriptions. In the last recorded year (2001) there were around 30 million prescription items for anti-depressant medication in the UK. "There is considerable evidence that older generation anti-depressant drugs and tranquillisers have an adverse effect on driving and can increase the risk of accidents but not enough work has been done on the relationship between the newer forms of medication and driving. "While medical opinion certainly considers that driving performance is not impaired as much, we don't know that definitely. Little research has been done which studies the accident risk of these drugs. It is imperative that Government implements the recommendations of their report and undertakes conclusive research about the safety of anti-depressant drugs for motorists. Patients taking anti-depressant medications should monitor their own driving behaviour and be aware of the possibility that their driving abilities might be influenced by the drug or its side effects and act responsibly. If in any doubt drivers should consult their GP." RAC Foundation's medical consultant Dr Tony Lavelle said: "Different drugs prescribed for depression can lead to a variety of reactions in different individuals. Obviously patients prescribed new drugs should be advised whether it is safe to drive and should read the small print. Anyone prescribed new medication for depression should not drive for two or three days anyway, to ascertain their true reaction to the new drugs. Individuals suffering anxiety or depression without significant memory or concentration problems, agitation, behavioural disturbance or suicidal thoughts, need not inform DVLA and may continue to drive depending on their medication. Others suffering more severe anxiety should crease driving, pending the outcome of medical inquiry." Publication: Nottingham Evening Post Distributed by Financial Times Information Limited <> << Copyright ©2003 Financial Times Limited, All Rights Reserved >>
13 Март, 2003
ARE WE FACING AN AUTISM EPIDEMIC?
** NOTE: TRUNCATED STORY ** FOR three months, Mail writer Melanie Phillips has been investigating the MMR controversy. Here, in the last of three major articles, she examines claims that the vaccine has triggered an epidemic of autism in our children - and how the evidence is piling up that official complacency is sorely misplaced. Daily Mail via NewsEdge Corporation : ** NOTE: TRUNCATED STORY ** FOR three months, Mail writer Melanie Phillips has been investigating the MMR controversy. Here, in the last of three major articles, she examines claims that the vaccine has triggered an epidemic of autism in our children - and how the evidence is piling up that official complacency is sorely misplaced. ACCORDING to the medical establishment, the whole idea is a nonsense. The suggestion that a new autistic bowel disease is now affecting large numbers of children who were previously normal until they were vaccinated with MMR is simply not borne out by the evidence. There is, say these experts, nothing new going on. All that's happened is that a few parents are desperate to invent a reason for the appalling disorder of autism that has afflicted their children. Autism often isn't noticed until the second year of life, which happens to be the time children are vaccinated with MMR. The parents, so the experts insist, have put two and two together and made five. So it came as a bit of a shock to attend the annual meeting of the Autism Society of America in Indianapolis last June. There I discovered upwards of 1,000 parents, most of whom told the same story: that their children were developing totally normally until they had MMR, following which their skills and personalities disintegrated and they developed appalling gut problems and food intolerances. Take Jeff Sell, a Texas lawyer with eight-year-old twins, Ben and Joe. Ben was born with an autistic disorder but Joe passed all the normal milestones until he had MMR. 'Joe had an immediate reaction with epileptic seizures, very high fever, rash and vomiting the next day,' said Sell. 'We took him to the doctor and were given the standard party line. In a few months after that the language he had developed had all gone, and chronic diarrhoea set in.' Or take Liz Birt from Chicago. Her eight-year-old son Matthew passed all his developmental milestones until he had MMR and Hib (haemophilus influenza type B) vaccinations at 15 months. 'That night he had a high temperature. Seven days later he started to have severe diarrhoea and stopped sleeping at night. He would wake at 1am and be up for the rest of the night. And he started screaming. 'I was very concerned because he wasn't growing and putting on weight. A few months later he started staring at lights, not making eye contact. 'Previously, he could count to ten, say mama and dada and ball but all these words went away. Then it seemed he wasn't hearing what we were saying at all.' Despite the fact that Matthew had chronic diarrhoea, doctors dismissed his mother's concerns. But then she took him to be examined by Andrew Wakefield's team at the Royal Free Hospital, London. Wakefield is the British doctor who first raised the alarm about MMR, linking it to autism and bowel problems. His team discovered that Matthew was in constant pain from a grossly impacted and diseased bowel something he believes is directly linked to autism following MMR jabs. Other parents tell similar stories. Tanya Reubarger from Indianapolis said of her five-year-old son Nathan: 'He was a perfectly normal baby until he had his injection. 'Then he started regressing, throwing violent tantrums, beating his head on the walls, beating his hands until they bled, frantic, always crying. He was eating normally but he had constant diarrhoea. Yet no one will believe you.' In Britain, the National Autistic Society says it has not noticed more reports of regressive autism and bowel disease following MMR. But other groups say this is because parents with such experiences don't join the deeply conservative NAS because it gives them no support. Such parents say that through their children's disorder, they have met countless other couples whose autistic children similarly developed normally until MMR provoked a catastrophic regression. And they say the claim by autism experts that they simply failed to spot autistic symptoms before the vaccination is demonstrably untrue, since so many of them have video recordings of their babies before vaccination showing them to have been perfectly normal. TRACEY STEELL from Glasgow has triplet boys, now aged eight. They had finished a course of antibiotics shortly before their MMR vaccination. Until then, they had been perfectly normal babies. Within a few days of the jab, one by one all three developed high fever, started to scream uncontrollably and then stopped developing. 'They didn't play, they just lay there, all three of them,' she said. 'They stopped playing with the dog and the cat, they didn't play with their toys, they didn't cry; if you picked them up they would just stare at you.' Because they were triplets, she said, the babies were continuously monitored by the hospital for the whole of their first year of life - and the hospital found nothing abnormal about them, giving the lie to the claim that such parents fail to recognise autistic symptoms present before vaccination. Jonathan Harris of Birmingham has six children. The two eldest, Ashley, 16 and Laura, 14, were too old to have MMR, and are normal children. The next two, Thomas, 12, and Oliver, eight, did have MMR. Within a week of the jab, Oliver started to scream and his behaviour regressed: he wouldn't make eye contact, wouldn't play and started throwing things around. Thomas developed bowel problems and lost his language skills. Harris is now looking for single vaccines for his two youngest, who are four and almost three. 'Most parents of autistic children that I have met have had similar experiences to us,' he said. 'I know dozens of such families.' What no one disputes is that in both Britain and America there has been a huge rise in the numbers diagnosed with either autism or autism spectrum disorder (ASD), which covers other developmental abnormalities. And what is striking is that this rise coincided with MMR vaccination being made a legal requirement in the U.S. in 1979 and being introduced into the UK in 1989 (although some experts claim - with figures that have been contested - that autism started to rise in the UK two years before MMR was introduced). The main U.S. figures are collated in California, the state with the most advanced services and reporting system for developmental disorders. Rick Rollens is a former secretary of the California state senate whose own son developed regressive autism after his booster MMR shot. 'Something happened in 1979-80,' he says. 'The pattern changed.' And the rise seems to be accelerating. Between 1987 and 1998, the proportion of autistic people using California's services almost doubled. Between 1987 and 1998, there was a rise of 273 per cent in the number of autistic cases in the state. According to Rollens, California is now adding on average seven new autistic cases per day to its register. The figures are borne out by studies of other parts of the U.S. They correspond to UK figures too. Until recently, the rate of ASD in Britain was estimated at between 5 and 20 per 10,000. The Medical Research Council now puts it at about 70 per 10,000, or one in 166. The National Autistic Society thinks that is an underestimate. In a study, it found the rate running at one in 86 in primary schools, a staggeringly high figure. Teachers are increasingly reporting that they are finding it difficult to cope with the new phenomenon of autistic children in their classes. Nevertheless, the medical establishment has long maintained that the numbers aren't really increasing. DR ERIC FOMBONNE, the child psychiatrist and renowned autism expert who is advising the drug companies that make MMR, has pooh-poohed the California figures and said the high autism rates merely reflect wider and better diagnosis and recognition. He has been backed up by Dr Patrick Bolton, a child psychiatrist and co-director of the Autism Research Centre at Cambridge University, who says the explanation for the rise is unclear. 'It's most likely to be at least in part due to the fact that we've changed our way of defining and diagnosing autism and we are better at spotting it. We've broadened the concept.' However, last autumn a study by the University of California concluded that the huge rise in autism was real and could not be explained away by changes in diagnostic practice or classification. And even Dr Fombonne now appears to be conceding that a significant change is taking place. In a recent article, he wrote that rates for the range of autism disorders were now three to four times higher than they were 30 years ago. The parents respond with fury and incredulity to the idea that such behaviour could simply have been overlooked in the past or mistaken for something else. In the U.S., Jeff Sell's wife was a special needs teacher in Spring, Houston. 'In 1994, she knew there were three children with autism in our district,' he said. 'Now there are 83. 'Are we being told that there were previously 83 children, all screaming and rocking and head-banging, and nobody noticed them? You don't miss autism. There are just more of them.' Judith Barnard of the NAS agrees: 'We have heard from parents that huge numbers of autistic children are being identified, and it wasn't like that when they were kids. 'So we asked schools whether they felt there were more autistic children now than five years ago and two-thirds of them said yes. There is a sense that something perceptibly different is happening.' Yet the establishment points to an apparent paradox which they say undermines the claim of a link with MMR. How can this be cause and effect, they say, when the rate of autism is still rising even though MMR uptake has stayed steady (or even gone down)? The response from the Wakefield camp is that MMR is not the only cause of autism. Many other factors may be involved, such as, for example, the dramatically rising rate of food and other allergies, or the increasing burden of other vaccines administered to infants. In the U.S., many parents believe that the mercury found in some vaccines other than MMR, such as the diphtheria/polio/tetanus jab, may weaken a child's immune system so that MMR becomes the final knockout blow. Dr Jeff Bradstreet runs a clinic for autistic children in Florida. He firmly believes that MMR is a devastating factor in a wider process that impairs children's immune systems. His own son Matthew was a normal baby until his MMR jab. 'Within two weeks of receiving MMR, Hib and chickenpox, Matthew was lost,' he said. 'He had chronic diarrhoea and regressed into a world of his own. After his booster MMR jab he had seizures.' Tests revealed he had a very high level of measles virus in his spinal fluid. 'A Congressional researcher and I called paediatricians all over the country and presented the lab data and the history and asked them for their diagnosis and they all said measles and encephalopathy (brain disease). 'We said he had autistic features and they said the encephalopathy was causing the autistic features. 'There are many toxins in the environment. Ultimately, I think you have a series of wounding events and then in a weak state the child is exposed to MMR.' The theory that too many vaccines at once overload the immature immune system is - like everything else in this story - controversial. The eminent immunologist Sir Peter Lachmann says: 'There's no limit to what the immune system can take; that's what it is for. There is no evidence that three living viruses administered at the same time overloads it. I think this idea is entirely drawn out of the air.' But Professor James Oleske, a paediatric immunologist in New Jersey, says: 'It's not the number of antigens in a vaccine that's the problem - it's the fact that in preparing them for the vaccine, other things are added to make them more effective.' Wakefield believes it is particular folly to mix viruses in a vaccine since this makes them unpredictable in their effects - a view Lachmann dismisses. 'Compound viruses do not interfere with each other's responses,' Lachmann insists. Others say Lachmann is profoundly wrong. Autism expert Dr Ken Aitken says studies have shown that combining viruses does indeed alter their effects and increases the risk of adverse reactions. The Department of Health argues that the triple MMR vaccine is safer for children than single jabs, which would expose them and others to a far greater risk of measles, mumps and rubella through slow or nonexistent take-up. Because of the controversy, however, MMR take-up is down by about 10 per cent to 84 per cent, and demand for single jabs has soared. Drug manufacturers are now limiting the availability of single vaccines, with claims by campaigners that the Health Department is leaning on the companies not to supply them. The perils of making it difficult for GPs to give single jabs on the NHS were underlined last month when two private clinics were shut down after it was found that their single vaccines were either ineffective or contaminated. Dr Richard Halvorsen is a London GP and one of the few who gives single vaccine jabs on the NHS. 'The arguments against providing single vaccines are irrelevant if parents won't give their children MMR,' he said. 'It seemed an overwhelming clinical argument to offer the single vaccine. By not offering it, we were contributing to the potential epidemic of measles that the department is purportedly trying to prevent.' To which the Health Department replies: look at Japan. In 1993, Japan abandoned MMR completely after it suffered an outbreak of aseptic meningitis triggered by the Urabe strain of mumps vaccine within the triple jab. Urabe-strain MMR had been withdrawn in Britain the previous year for the same reasons (shamefully, the Health Department had known of the dangers when it was introduced) and replaced with an updated version. JAPAN, by contrast, switched entirely to single jabs. This has resulted, says the Health Department, in a measles epidemic in Japan and 79 deaths from the disease between 1992 and 1997. On the face of it, then, this seems a strong argument for sticking with MMR. But Dr Hiroki Nakatani, director of the Infectious Disease Division at Japan's Ministry of Health and Welfare, has a very different story to tell. He says that in 1989, when Japan first introduced MMR, there were 34 deaths from measles; in 1990, there were 53 deaths; in 1991, 39; and in 1992, 14. Then, in 1993, the Japanese government moved from recommending MMR to single vaccines instead. The number of deaths from measles per year has since remained at between 14 and 25. So in fact, in the years Japan was using MMR there were on average rather more deaths from measles quite apart from any deaths and serious damage done by the vaccine - than since single jabs were introduced. <> ** NOTE: This story has been truncated from its original size in order to facilitate transmission. If you need more information about this story, please contact NewsEdge Corporation at 1-800-766-4224. ** << Copyright ©2003 Financial Times Limited, All Rights Reserved >>
12 Март, 2003
Культура и вырождение - Освальд Бумке

Культура и вырождение - Освальд Бумке

12 Март, 2003
Best-selling drug should be withdrawn - coroner
THE world's best-selling antidepressant should be withdrawn from sale in the UK, a coroner said yesterday after linking the drug to the death of a retired Welsh teacher. The Western Mail via NewsEdge Corporation : THE world's best-selling antidepressant should be withdrawn from sale in the UK, a coroner said yesterday after linking the drug to the death of a retired Welsh teacher. Geraint Williams added his voice to a growing body of health experts concerned about a link between Seroxat and suicide after hearing how Colin Whitfield killed himself just two weeks after starting a course of the drug. Mr Williams will now call on the Department of Health to undertake an urgent inquiry into the controversial anti-depressant, which is manufactured by GlaxoSmithKline and prescribed to millions of people around the world. Speaking at the inquest into the death of 56-year-old Mr Whitfield, the Brecon coroner said, ``I have grave concerns that this is a dangerous drug that should be withdrawn until at least detailed national studies are undertaken. ``It is my intention to write to the Department of Health and the Secretary of State to ask him to hold an urgent inquiry into Seroxat and consider whether it should be withdrawn from sale in the UK. ``I am profoundly disturbed by the effect this drug had on Colin Whitfield,'' he said. ``It is quite clear that Seroxat has a profound effect on the thinking process of anyone who takes it.'' Mr Whitfield, who was described as a protective and loving father,died after cutting both his wrists on August 29 last year. He had locked himself in the garden shed at his home near Brecon while one of his daughters was asleep nearby. Just 14 days earlier, his GP had prescribed him Seroxat to treat anxiety. His wife of 30 years, Kathryn, told the inquest, said, ``I don't believe this was a conscious decision, I don't think it was an intentional act. There was no way he was in his right mind when he did that. ``There was no note and no intent. Two days before he died, on his birthday when he was opening presents, he asked, `What more can I ask for than my lovely family?' ``And on the night before he died he did and said three things that indicated he was planning ahead.'' She added, ``It didn't fit the picture of who he was and we have no doubt that it was the drug that caused him to do it. ``What he did was so totally out of character - he was a very caring, very protective father and husband. He would be hating himself for what he has done to his family.'' Seroxat was originally licensed as a treatment for depression but its use has now been expanded to cover obsessive compulsive disorder, panic disorder, anxiety and posttraumatic stress. But while it has proved successful for many users, manufacturer GSK is facing the prospect of legal action from users and their families on both sides of the Atlantic amid claims the drug is addictive, and can prompt suicide and violent and aggressive behaviour. Cardiff-based solicitors Hugh James, which is leading the action in the UK, is representing 4,000 people who claim they have been adversely affected. The inquest heard that concern about the safety of the drug has increased since June 2001 when a jury in the US ordered GSK to pay $6.4m to the relatives of 60-year-old Donald Schell who killed his wife, his daughter and granddaughter before turning a gun on himself in 1998 in Wyoming. He had been taking Paxil - the American name for Seroxat - for just two days. Since it was licensed for use in the UK in 1990, almost a quarter of all reports of fatalities from licensed medicines made to the Medicines Control Agency related to the use of Seroxat, said Mr Williams. And a third of all adverse incidents reported by doctors as part of the yellow card reporting scheme between 1991 and 1997 related to the use of the drug. Clinical studies into Seroxat - a second generation selective serotonin re-uptake inhibitor (SSRI) - have found a higher risk of suicide or attempted suicide in patients on the drug compared to other SSRIs or a placebo, and healthy volunteers have dropped out of similar Seroxat studies because of the onset of suicidal thoughts and tendencies. Research has also indicated that Seroxat, classed as a psychotropic drug, can cause ``emotional blunting'' in some people, meaning they are more likely to act on thoughts they would normally dismiss. In written evidence to the inquest, UK Seroxat expert Dr David Healy, director of the North Wales department of psychological medicine, said SSRIs caused a series of conditions which can increase the risk of suicide and it was common to find that people who are prescribed the drugs say they are ``simply not bothered any more'' and engage in ``out of character behaviour''. And his report said, ``Based simply on the research done and the figures available, and without close consideration of Mr Whitfield's case, there are good grounds to say an individual can commit suicide during the early time frame on an SSRI, but that individual is unlikely to have formed a consent to commit suicide in the normal fashion.'' In deciding to record an open verdict into Mr Whitfield's death, Mr Williams said, ``I have a picture of a kindly, gentle, courteous family man whose primary concern was his wife and children. But on this day he didn't care. ``He did a deliberate act affected, I have no doubt, by the taking of Seroxat.'' In a statement from Glaxo -SmithKline, a spokeswoman last night said, ``GSK offers its sincere condolences to the family of Colin Whitfield. ``As yet we do not have any official information from the court as the coroner is still sitting. ``We take the reporting of adverse events very seriously. The safety of all medicines is continually monitored by both GlaxoSmithKline and the Medicines Control Agency. ``Fortunately, with Seroxat we have a wealth of positive experience involving thousands of physicians, millions of patients and over 10 years of experience world-wide. ``There is no valid scientific research or literature finding that Seroxat causes suicidal thoughts or acts. Suicide can be a recognised component of depression. ``Fifteen per cent of all those suffering from depression eventually commit suicide. About 70% of the 4,000 suicides a year in Britain are people suffering from depression. ``We believe in the safety profile of Seroxat and will vigorously defend the integrity of our medication.'' Publication: The Western Mail Distributed by Financial Times Information Limited <> << Copyright ©2003 Financial Times Limited, All Rights Reserved >>