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Vaccines and Autism: Can the Causal Link Be Proven in Law?
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Posted by lightfoot on Tuesday, March 18, 2008 (17:51:54)
By Serena Wolfond, L.L.B. Candidate 2010
In order to prove that the MMR vaccination causes autism it must be apparent: (a) that but for the administration of the vaccination, autism would not be present, and (b) that (a) is true on a balance of probabilities (i.e. that it is more likely true than not true).
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Melatonin well-tolerated sleep aid in children with autism
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Posted by lightfoot on Tuesday, February 26, 2008 (00:04:53)
Vanderbilt Sleep Disorders Center researchers are reporting that melatonin, an over-the-counter and relatively inexpensive dietary supplement taken for insomnia and jet lag, shows promise in treating children with autism who have difficulty falling asleep.
Beth Malow, M.D., associate professor of neurology and Kennedy Center investigator, and collaborators reviewed clinical data from Vanderbilt Associate Professor of Pediatrics Susan McGrew, M.D., that showed the dietary supplement was safe and well tolerated in her patients. The results are published in the February issue of the Journal of Child Neurology.
The study is the largest of its kind, looking at the medical records of 107 children with autism, ages 2-18, who had tried varying dosages of melatonin for insomnia. Twenty-five percent of parents reported they no longer had sleep concerns after using melatonin, 60 percent of parents reported the sleep problems had improved, 13 percent still had major concerns and only 1 percent (one child) had worse symptoms. Only three of the 107 children studied reported mild side effects.
“Although prospective trials will be needed to determine if melatonin is an effective sleep aid in this population, this study does support that it may be a reasonable treatment option in these children when administered under the care of a physician and combined with behavioral therapies for sleep,†Malow said.
Autism Speaks, in conjunction with the Dana Foundation, is contributing $100,000 over two years to a prospective study led by Malow and McGrew. This study will follow how sleep patterns change in children with autism with the introduction of melatonin, as measured by parent reports and a method called actigraphy, which monitors sleep by tracking movements at night via a wristwatch-like device.
Although preliminary, so far all children completing the trial have had improved sleep, improved daytime behavior, and parents report that they are coping better with their child’s autism.
“This has had a big impact on the family,†Malow said.
In addition to McGrew, Malow's collaborators include Karen Adkins, R.N., CCRC, research nurse specialist and project manager; Wendy Stone, Ph.D., professor of Pediatrics and director of Vanderbilt's Treatment and Research Institute for Autism Spectrum Disorders; Lily Wang, Ph.D., assistant professor of Biostatistics, Suzanne Goldman, Ph.D., instructor in Neurology, and Courtney Burnette, Ph.D., assistant professor of Psychiatry.
For more information contact Karen Adkins at (615) 936-1646 or e-mail: autismsleepresearch@vanderbilt.edu.
Vanderbilt University News Service
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Researcher speaks out on vaccines and autism
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Posted by lightfoot on Sunday, February 24, 2008 (12:17:05)
MARK ROTH; Pittsburgh Post-Gazette
Published: February 1st, 2008 01:00 AM
PITTSBURGH – Nancy Minshew is ready to take off the gloves.
After years of sitting back and hoping the science would speak for itself, the director of the University of Pittsburgh’s Center for Excellence in Autism Research has decided it’s time for her to take a stand.
Autism isn’t caused by vaccinations, she says, and those who continue to push that theory are endangering the lives of children and misdirecting the nation’s scarce resources for autism research.
“The weight of the evidence is so great that I don’t think there is any room for dispute. I think the issue is done,†said Dr. Minshew, who runs one of nine top autism research centers funded by the National Institutes of Health.
“I’m doing this for all the families out there who don’t have a child with autism, who have to deal with the issue of’ ‘Do I get a vaccination, or do I not do it and risk my child’s life?’ because they don’t understand what the science is saying.â€Â
NETWORK STICKS WITH SHOW
Her decision to speak out came as ABC was slated to air the pilot of a TV drama, “Eli Stone,†in which a young lawyer pursues a lawsuit on behalf of a woman who believes mercury in a vaccine caused her son’s autism.
The episode, which was to air Thursday, upset the American Academy of Pediatrics so much that it asked the network to pull the show. The Walt Disney Co., which owns ABC, declined to do so, but agreed to run a disclaimer that will direct viewers to the federal Centers for Disease Control and Prevention’s autism Web site.
That site will tell visitors what’s been known for several years: Virtually every mainstream public health and research organization – including the congressionally authorized Institute of Medicine, the CDC and the NIH – says there is no credible link between vaccines and autism.
That hasn’t stopped a determined group of parents, iconoclastic researchers and lawyers from arguing that there is a link and that the government and drug companies have conspired to hide the truth.
“Eli Stone†picks up on that theme, and while ABC asserted that the program presents both sides of the argument, the drama leans toward the vaccine-autism connection.
‘THAT’S CALLED FAITH’
In real life, the main target of suspicion has been thimerosal, an ethyl mercury preservative that kept vaccines from being contaminated once they started to be used in a doctor’s office or clinic.
In the TV drama, it’s called “mercuritol,†and the Eli Stone character says this during his closing argument to the jury:
“Is there proof that mercuritol causes autism? Yes. Is that proof direct or incontrovertible proof? No. But ask yourself if you’ve ever believed in anything or anyone without absolute proof. That’s called faith.â€Â
Adding to the aura of conspiracy surrounding the debate, the script also has the lawyer saying to the jury, “The first lawsuit alleging a connection between tobacco and cancer was filed in 1954, but it took 30 years for a jury to award a single dollar for something we all now accept as patently true.â€Â
After watching an advance copy of the program at the Pittsburgh Post-Gazette’s request this week, Minshew said she thought it was well done.
“It’s great entertainment,†she said. “If it didn’t set off this whole other issue, I would think it was cute.â€Â
She was particularly perturbed by the tobacco reference in “Eli Stone.†The evidence of heart and lung damage from smoking was overwhelming for years before tougher cigarette regulations were enacted, but there’s no such parallel in the studies that have alleged that vaccines cause autism.
One of the main pieces of evidence against the vaccine theory, Minshew said, is that thimerosal has been banned from most childhood vaccines in America since 2001, and yet reported autism rates have continued to increase.
TheNewsTribune.com
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Medication : Behavioral and Pharmacologic Treatment of Aggression in Children With Autism
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Posted by sylvia on Saturday, December 17, 2005 (13:17:20)
Psychiatric Times October 2005
By Craig A. Erickson, M.D., Naomi B. Swiezy, Ph.D., Kimberly A. Stigler, M.D., Christopher J. McDougle, M.D., and David J. Posey, M.D.
Autistic disorder (autism) is a childhood-onset disorder characterized by marked impairments in social interaction, communication and behavior. Aggression is a frequent reason for psychiatric referral in this population. As such, the clinician needs to be knowledgeable regarding aggression assessment and treatment. This article will provide an overview of treatment modalities, with emphasis on the future direction of interventions targeting aggression in children with autism.
Assessment
Behavioral and pharmacologic interventions cannot begin until the patient has been thoroughly assessed in terms of diagnosis, cognitive abilities and other factors related to the complaint of aggression. In identifying these factors, it is important to begin with a detailed inquiry as to the duration, frequency and severity of the aggression, as well as precipitating or exacerbating factors. Evaluation for comorbid psychiatric disorders (e.g., major depression) and symptoms (e.g., impulsivity), as well as medical conditions (e.g., epilepsy), is also important in guiding interventions.
An initial behavioral assessment, called a functional analysis, is performed prior to behavioral therapy. Functional analyses are controlled observational sessions that are conducted to objectively determine the primary motivating factor for the child's misbehavior. Primary motivational factors or functions of behavior are typically to seek attention, access a preferred item or escape a task. Another function may be that the child engages in a behavior that is inherently pleasurable. As such, determination of any appropriate and beneficial treatment approach would be selected on the basis of the empirically determined motivational factor, rather than on arbitrary selection (Hagopian et al., 2001).
Behavioral Interventions
Behavioral interventions, particularly those based upon applied behavior analysis (ABA), have long had empirical support for addressing problematic behavior (for a review, see Schreibman, 2000). These methods have been utilized for a wide range of disorders and myriad behavioral difficulties (Heflin and Simpson, 1998) and have not been exclusively utilized for the treatment of autism. However, intervention with roots in ABA has been regarded as one of the primary forms of treatment, given its stability in the literature and practice over decades, as well as the fact that it lends itself to objective evaluation.
In general, ABA refers to methodologies based in operant conditioning theory and presumes that antecedent stimuli and consequences influence acquisition and continuation of behaviors. Objective assessment of observable and measurable behaviors and ongoing evaluation of the behavior change is inherent in treatment success. Particularly in the field of autism, terminology has often become muddled over the years. Many particular methodologies are equated to the whole of ABA, as opposed to being one tool or method within this rubric.
Specific methodologies enveloped within the field of ABA include Lovaas therapy or discrete trial teaching (Lovaas, 1987) and incidental teaching (McGee et al., 1999). Although based on the principles of ABA, these specific methodologies should be viewed as distinct interventions within the general framework of ABA.
Several behavioral strategies have been shown to be effective in decreasing severe aggression and self-injury (Kahng et al., 2001). Since intervention methods are best employed on a consistent and daily basis, parental involvement is very important (Briesmeister and Schaefer, 1998). In fact, parents and other caregivers are often a primary focus of training in ABA methods. There are many challenges in providing this training, as well as ensuring consistent implementation of treatment intervention, particularly for behaviors such as aggression.
Follow-up visits to coach the caregivers and ensure protocol fidelity are often infrequent. In addition, caregivers working in naturalistic settings with these children face inherent multiple challenges and competing time pressures on a daily basis. Providing prevention techniques that will prevent or limit the development of maladaptive behavior is more realistic in these settings (McClannahan and Krantz, 2004).
In addition, there has been documented success of parent and staff training interventions based in ABA to improve the caregiver's abilities to provide all levels of prevention, treatment intervention and skills acquisition. In particular, Harris et al. (in press) have completed a comprehensive review of the methods and strategies considered most useful for consistent and effective treatment implementation. Included are instructions, modeling/role-playing and corrective feedback, as well as ongoing consultation.
While much single-case research supports ABA intervention, randomized control trials have not thoroughly evaluated the efficacy of a standardized behavioral intervention program. The difficulty in doing so is inherent in the particular strength of behavioral analytic techniques to individualize the treatment to the characteristics and interests of the particular child. The National Institute of Mental Health recently funded three Research Units on Pediatric Psychopharmacology (RUPP) that are focused on autism and related pervasive developmental disorders (PDDs).
The RUPP Autism Network has begun a controlled investigation into the use of a standardized behavioral intervention, targeting severe behaviors such as aggression and self-injury. Although the behavioral programming is not specific to the principles of ABA and will not prove the particular success of such an intervention with this population, the investigation will provide some input as to the benefit of incorporating general behavioral methods along with psychopharmacological intervention. Furthermore, it will provide a basis for manualizing a behavioral intervention so therapists without extensive experience with children with autism will have some guide to appropriate intervention strategies.
Pharmacotherapy
Several drug classes, including antipsychotics, serotonin reuptake inhibitors, mood stabilizers, psychostimulants and adrenergic agonists, have been evaluated in studies where aggression was a primary target in children with autism.
Antipsychotics. Typical antipsychotics were among the first agents assessed in an organized manner. Haloperidol (Haldol) decreased emotional outbursts and anger in placebo-controlled studies including young children with autism (Anderson et al., 1984). However, its role is limited due to concerns about dystonic reactions and dyskinesias (Campbell et al., 1997).
Atypical antipsychotic drugs have a reduced propensity to cause motor side effects and have largely replaced haloperidol in the clinical treatment of autism. Clozapine (Clozaril), quetiapine (Seroquel), olanzapine (Zyprexa) and ziprasidone (Geodon) have been evaluated in small or uncontrolled studies and case reports (Erickson et al., in press). Each of these drugs, with the exception of ziprasidone, is associated with frequent weight gain. Clozapine has additional liabilities, given its propensity to decrease the seizure threshold and requirement for frequent venipuncture.
Among the atypical antipsychotics, risperidone (Risperdal) has received the most attention in treating maladaptive behaviors in patients with autism. This drug has been the subject of controlled trials in both adults (McDougle et al., 1998) and children (McCracken et al., 2002; Shea et al., 2004). McCracken et al. (2002) compared risperidone (mean dose=1.8 mg/day) to placebo in an eight-week, randomized, double-blind trial in 101 children with autism. Risperidone was markedly efficacious in reducing aggression and irritability.
Side effects included weight gain, increased appetite, sedation, tremor and hypersalivation. Shea and colleagues (2004) also reported that risperidone (mean dose=0.04 mg/kg/day) was efficacious in reducing irritability, conduct problems, anxiety and hyperactivity in an eight-week, double-blind, placebo-controlled study of risperidone in a sample of 79 children. They also found significant weight gain, as well as increased pulse and systolic blood pressure in the risperidone-treated group.
Our group recently reported that aripiprazole (Abilify) (mean dose=12 mg/day) was effective for reducing aggression, agitation and self-injury in five youth with PDD (Stigler et al., 2004). During open-label aripiprazole treatment (mean duration=12 weeks), two patients experienced mild somnolence, but no changes in vital signs occurred. Weight loss was also noted. This weight loss may have been associated with patients discontinuing other medications that had caused excess weight gain. We are currently conducting a large placebo-controlled trial of aripiprazole for children and adolescents with autism and aggression.
Other psychotropic agents. Clonidine (Catapres), an α2-adrenergic agonist, was efficacious in two short-term, placebo-controlled trials, but its long-term efficacy has been questioned (McDougle et al., 2003). Guanfacine, a longer-acting α2-adrenergic agonist, was only effective in 19 of 80 (24%) patients with PDD at mean treatment duration of one year (Posey et al., 2004b). Out of 69 patients with significant aggression, it was only effective in 10 (14%) patients.
Case reports and a retrospective review have reported on the use of lithium (Eskalith, Lithobid) or divalproex (Depakote) for aggressive behaviors in youth with autism (McDougle et al., 2003). While we expect more reports on the use of mood stabilizers in the future, our clinical experience, combined with available evidence, suggests that mood stabilizers will not be as effective as atypical antipsychotics in treating aggression.
The tricyclic antidepressant clomipramine (Anafranil) has shown some promise in treating aggression in one placebo-controlled trial (Gordon et al., 1993). Secondary to concerns over tolerability and the availability of safer selective serotonin reuptake inhibitors, the use of clomipramine has been limited.
Fluvoxamine (Luvox) (mean dose=277 mg/day) was evaluated in a 12-week, randomized, placebo-controlled trial in 30 adults with autism (McDougle et al., 1996). Fluvoxamine was associated with significant global symptom improvement, as well as a reduction in maladaptive behavior and aggression. The same group conducted a similar study in 34 children with PDD but noted increased aggression without overall improvement (McDougle et al., unpublished data).
Hollander and colleagues (2005) reported on an eight-week, double-blind, placebo-controlled crossover trial of liquid fluoxetine (Prozac) in 45 children and adolescents with PDD. There was a reduction in repetitive behaviors but less reduction of global symptoms. Overall, SSRIs as first-line agents in targeting aggressive behaviors in children with autism is not currently supported by the available literature.
While psychostimulant treatment has been associated with reductions in aggression in children with attention-deficit/hyperactivity disorder, results in autism have been equivocal. Posey et al. (2004a) reported on a randomized, placebo-controlled, crossover study of methylphenidate (Ritalin, Concerta, Metadate) in children with PDD. Methylphenidate treatment was associated with small-to-medium improvements in hyperactivity but caused irritability in some patients. There was no improvement in aggression.
Conclusion
A comprehensive treatment plan for treating aggressive behaviors in children with autism begins with a precise and thorough assessment, followed by implementation of a comprehensive treatment plan. This treatment plan must incorporate ongoing behavioral assessment and intervention with continuous evaluation for areas in which pharmacotherapy could potentially curtail maladaptive and dangerous behaviors.
From a pharmacotherapy perspective, atypical antipsychotics, particularly risperidone, have shown the most promise in reducing aggressive behavior. Future directions in treating aggression in children with autism include further investigation of atypical antipsychotics that may not cause significant weight gain and testing the efficacy of manualized behavioral treatments.
Dr. Erickson is a resident in psychiatry at the Indiana University School of Medicine and the Christian Sarkine Autism Treatment Center (CSATC).
Dr. Swiezy is clinical associate professor of psychology and psychiatry at the Indiana University School of Medicine and clinical director of CSATC.
Dr. Stigler is assistant professor of psychiatry at the Indiana University School of Medicine.
Dr. McDougle is the Albert E. Sterne Professor and chairperson of the department of psychiatry at the Indiana University School of Medicine.
Dr. Posey is associate professor of psychiatry at the Indiana University School of Medicine and chief of CSATC.
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Medication : New ADHD drug launched in UK
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Posted by Sylvia on Thursday, June 03, 2004 (09:02:04)
BBC Online 03/06/2004
A new drug to treat ADHD - attention deficit hyperactivity disorder - has been licensed for use in the UK.
The launch will reignite the debate about whether it is right to use drugs to control the condition, thought to affect around 5% of children.
The drug, amoxetine, has been welcomed as an alternative treatment if existing drugs do not help.
But some experts say diet should be used to manage children's symptoms instead.
Unlike currently available drugs, amoxetine, which will be available on prescription from July, is not a stimulant, and therefore is unlikely to carry a potential for abuse.
Children with ADHD have extreme difficulty sitting still, learning or concentrating. Looking after affected children can be exhausting for parents.
Guidelines from the NHS watchdog the National Institute of Clinical Excellence say only the most severely affected should be given drug therapy.
Until now, only the methylphenidate class of drugs - which includes Ritalin - have been available to treat ADHD.
Some doctors have expressed concern it could lead to depression or be abused by drug-users because of its amphetamine content.
It has also been seen as a "chemical cosh" by some parents, teachers and doctors, who say it suppresses, rather than modifies, behaviour.
But experts say drugs like Ritalin are likely to remain the first choice drug therapy for ADHD, with amoxetine as an alternative option if they do not help.
There is also agreement that diets can be effective in relieving ADHD symptoms. However, they are often time consuming and expensive for families.
'Normal life'
Atomoxetine, which is also known as Strattera, is a non-stimulant and the first new type of medication to be licensed in the UK for 30 years.
One dose lasts for 24 hours. Drugs such as Ritalin cause insomnia, so are not taken in the evening, meaning symptoms are not controlled at night or in the early morning.
Dr David Coghill, senior lecturer in Child and Adolescent Psychiatry, University of Dundee, said, "Continuous relief from the symptoms of ADHD is something we've not seen before.
"It may allow children and their families the opportunity to live a more normal life with respite from the disruption of ADHD."
Professor Peter Hill, a child and adolescent psychiatry who has specialised in ADHD care: "The availability of this drug is a good thing. It is an advance.
"However, drugs such as Ritalin (methylphenidates) will remain the drug of choice.
"We have been using them for 50 years, and we know how they work.
"It the methylphenidate does not work, doctors would probably try another stimulant before moving to amoxetine.
"But I think amoxetine will remain a second or third choice drug for the foreseeable future."
'Diet is key'
Andrea Bilbow, chief executive of the National Attention Deficit Disorder Information and Support Service (ALDDISS), said Strattera offered a treatment option for children who did not benefit from drugs such as Ritalin.
"It remains to be seen how many children this will help, but its another option for children and parents to look at.
"But it's potentially able to give children a normal life."
However Angela Beecroft, a clinical nutritionist at the Cactus Clinic which aims to treat ADHD and related conditions without drug therapies, said: "There is a place for drugs, but only in the short-term, to get the child into a calm state of mind."
She said raising levels of minerals such as zinc and magnesium could in themselves relieve ADHD symptoms.
"Most of these are missing in the diets of children we see."
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