Results reported for SOFIA
February 18, 2009
Autism Speaks Announces Results Reported for the Study of Fluoxetine in Autism (SOFIA)
First Industry-Sponsored Trial for the Autism Clinical Trials Network (ACTN)
NEW YORK, N.Y. (February 18, 2009) – Autism Speaks today announced initial results reported for the first industry-sponsored trial of the Autism Clinical Trials Network (ACTN), the Study of Fluoxetine in Autism (SOFIA). These results showed that fluoxetine was not effective for reducing repetitive behaviors in children and adolescents with Autistic Disorder as compared to placebo (non-medicinal sugar pill). The study was carried out in collaboration with study sponsor, Neuropharm Group Plc., a specialty pharmaceutical company focused on neurodevelopmental disorders.
The study evaluated the efficacy and safety of Neuropharm’s new low-dose form of fluoxetine, known as NPL-2008, which is designed specifically for the treatment of Autistic Disorders in children and adolescents. NPL-2008 uses the Zydis® melt-in-the-mouth formula, intended to be an easier form of the medication for children. The study showed that repetitive behaviors were reduced when children were given either NPL-2008 or a placebo, but no differences between groups were found in terms of the level of reduction of repetitive behaviors. Thus, it was concluded that NPL-2008 was not more efficacious than the placebo. The new formulation was generally well tolerated by patients and no serious adverse events were reported.
Geraldine Dawson, Ph.D., Autism Speaks’ Chief Science Officer remarked, “The development of effective drugs that are easily taken by individuals with autism is an important goal. While it is disappointing that NPL-2008 was not found to be effective for reducing repetitive behaviors, this study does highlight the importance of high quality, rigorously controlled clinical trials. Studies like this help build the evidence-base and offer parents guidance in making more informed decisions about their child’s clinical care.”
The Autism Speaks ACTN was launched in 2005 to address the need for more thoroughly tested biological treatments for autism. The ACTN provides a platform to rigorously test the safety and efficacy of existing compounds, most of which do not have specific indications or specific dosing instructions for their use in autism. These treatments are prescribed by medical practitioners for “off-label” use.
Fluoxetine is one of the most widely prescribed central nervous system (CNS) drugs for disorders such as anxiety, depression, and obsessive-compulsive disorder. It has been prescribed “off-label” by physicians to alleviate repetitive behavioral symptoms in autism. Smaller studies in children and adults showed promising results, but there had not been a large scale study of this type to systematically confirm the efficacy of the drug for reducing these behaviors in autism. Currently, there is only one treatment with a specific FDA-approved indication for autism, but it does not target the core symptoms of autism.
The SOFIA study is the largest trial ever conducted in patients with Autistic Disorder. The study was carried out across 19 ACTN medical centers and clinical sites throughout the US. A total of 158 patients between the ages of 5 and 17 were enrolled into the SOFIA study in which patients received either NPL-2008 or placebo during a 14 week treatment period. The full analysis of the primary and secondary data from the study is ongoing.
Peter Bell, Executive Vice President for Programs and Services commented, “Finding safe and effective medications that treat the core symptoms of autism is one of the greatest challenges facing our community. One of our primary goals at Autism Speaks is to help identify effective treatments that lead to improved quality of life for all those affected by autism.”
Robert Mansfield, Neuropharm’s CEO, stated “These initial results are both unexpected and disappointing, and we await the results of the full analysis which is currently ongoing. We would like to thank Autism Speaks’ Autism Clinical Trials Network who facilitated the timely completion of this study and to thank the teams at the sites involved in SOFIA.”
Tax Benefits
February 17, 2009
Educating a child with autism and providing them with essential treatment is a costly endeavor - but one worth doing if you can find a way to manage it financially. We were surprised to find how much of the costs are tax deductible. It was nice to know that we got some kind of break after everything we have been through. I saw this article that explains the taxes and I thought it was worth passing along.
http://www.greatschools.net/cgi-bin/showarticle/1187?cpn=20090205ld
The Back Room Kids
February 16, 2009
This is so beautifully written. I often can’t find the words to describe how I feel about autism, how absolutely amazing, intriguing, and fascinating I see these kids.
The Back Room Kids: Shame, Guilt and the Autism Myth
By William Stillman
Last fall, I made an autism presentation in Los Angeles to a group of 200 exclusively Spanish-speaking parents. They were grateful and gracious, and many made efforts to communicate with me in English (I otherwise had translators). When I stood before them, I affirmed that their autistic children are intelligent, gorgeous human beings entitled to the space they occupy. I was stunned by the collective reaction of the audience: people sobbed in relief; grown men, fathers, buried their faces in their hands; and others gave me their children’s pictures, asked to take my picture, or requested my inscription. I was overwhelmed, almost uncomfortably so. Here was a group of people who, as a minority, are already devalued in many ways; because of language barriers, some may have been perceived as gullible or unaware of their options as parents. They were so appreciative of a positive message, I thought to myself, “My gosh, what have these people been told about their children!” I surmised that each felt shame and guilt for parenting a child with autism.
What drives this kind of reaction? Two things, in my opinion. First, there is still a very prevalent medical model in how autism is defined. It is listed in the Diagnostic and Statistical Manual of Mental Disorders, which immediately sets the negative precedent that autism is a mental illness (it’s not) and requires intensive treatment. This is further perpetuated by some clinicians who are not sensitive or compassionate when making a diagnosis, or who are unaware of quality resources to direct parents to. (Inconceivably, there are still doctors who suggest that autism is attributable to parental blame, or recommend parents institutionalize their children.)
Second, the media often stigmatizes autism as a tragic affliction to be feared or pitied. In addition to Asperger’s Syndrome, I have a same-sex orientation. I would no sooner expect an interviewer to define my sexuality using a derogatory slur because it would be an outrageous violation, yet it is presently acceptable for the same interviewer to describe me as “suffering from a severe disorder.” Until the Rosa Parks of autism emerges, this will persist. At the least, much media representation of autism reinforces antiquated stereotypes, and that is a disservice.
From the outset, many parents are portrayed a grim projection for their child’s future. They are led to believe their children with autism are incapable, unaware and of substandard intellect, a lost cause that will always function at the level of a four-year-old, even as an adult. This often results in parenting approaches of two extremes: tireless endeavors to eradicate autism through high-cost, intensive, one-on-one (adult to child) behavior therapy for countless hours on end (that, in some cases, may involve a regimen of physical restraints and anti-psychotic medications). Or it results in the “back room kids.”
The proper response to autism is to re-envision it as a neurological disconnect relative to those with Cerebral Palsy, Tourette’s, Hodgkin’s, Parkinson’s, Lou Gehrig’s, recovering from stroke, or any other such experience that compromises brain-body connections and impairs movement or articulation of speech. Even though the physical is unreliable or not of good service, the cerebral is intact, thought processes operate at capacity, and mental capability is completely competent (it just doesn’t measure that way through I.Q. scores). There is emerging scientific research to support the re-evaluation of autistics using non-verbal intelligence testing to reveal their true intellect commensurate with, or beyond, their chronological age.
Some parents who don’t foresee true intellect as a possibility for their children, due to the preceding conclusions, have bought into the myth of autism-that is, autism equals intellectual inferiority or mental retardation. In addition to shame and guilt, despair, denial and hopelessness may prevail. The thinking may become that of day-to-day maintenance and minimal standards of care giving. Hence, the back room kids.
I see them, watching me from their baby-gated existence of the screened-in porch or the distant bedroom at the rear of the house. Many of them don’t have much meaningful connection with their families. They have free-reign to do as they please because parents are afraid to apply fair discipline or have been told not to because their child won’t understand. Some back room kids are overweight, have poor diets and are provided age-inappropriate books, toys and videos. Some are still on bottles and in Pampers at age five.six.nine. This is unacceptable.
When I meet them I think: “I see you there, little one. You with your grubby bag of orange cheese curls and the Veggie Tales video repetitively looping. You with your bright, glistening, welcoming eyes. You with your hunger for knowledge and information beyond the back room, or even your back yard. I see how very smart you are inside. I see you.”
Refusing the myth of autism, building relationships founded upon a belief in competence, and challenging autistic intellect is what will create a cultural shift for the growing numbers of very young children diagnosed with autism each day. It will also yield hope for the adults with autism who have endured in silence, only offered Little Golden Books, Strawberry Shortcake puzzles, and Lady and the Tramp videos.
The regrettable irony is that we have a long and unfortunate history of back room kids-”retarded defectives” as they were once known-only, in another era, the back room was confinement to the basement or an attic. Shame and guilt were very much a motivation for those parents then as much as it is for some parents now.
Isn’t it curious that what’s called for is simply acquiescing our own agendas and compelling ourselves to be more sensitive-to listen fruitfully with our ears as well as our eyes? We’re not only talking about presuming intellect, we’re talking about demonstrating a renewed respect.
© 2008, William Stillman
William Stillman is speaker, consultant, self-advocate and author of numerous autism and special needs parenting books. His Website is www.williamstillman.com.
Special Schools for “Special” Kids
February 15, 2009
To give us all something to think about:
Special Schools for “Special” Kids:
If You Build Them, They will Come
By William Stillman
I was recently interviewed by the mother of a son with autism for an autism-specific publication. One of her queries asked me to reflect upon how far we’ve come in meeting the needs of kids with different ways of being. I paused briefly to review my work in this field since 1987 (longer still if you count the couple years I taught school).
I’ve seen the “special ed” classes with those children deemed “higher functioning” who were “mainstreamed” into regular education for a “special,” such as art, music or gym. They never really were included, socially that is-but wasn’t that the point, to encourage acceptance from their typical peers?
I’ve toured state institutions, rural, self-contained communities to which countless “defective” individuals were sent away-sent away from their families and everything familiar to them. Parents were comforted in believing that the “experts” were better equipped than they to manage (that is, raise) their “retarded” sons and daughters from afar and in isolation of their communities.
And most recently, I’ve conducted consultations at “special schools” for those with autism, from kindergarten age to twenty-one-year olds. They are immaculate, well-maintained facilities, usually out in the middle of nowhere and staffed by dedicated, well-intentioned people who want to make a difference in the lives of their students.
I had to answer the interviewer’s question honestly. No, we haven’t made any progress whatsoever. In fact, the pendulum is dangerously close to swaying backwards in time to an era when the segregation observed just within the scope of my professional history was acceptable and condoned.
I am hearing so much about funding to erect still further special schools for “special” children (almost exclusively those with autism). I worry that young parents of children newly-diagnosed think nothing of supporting such efforts. And I anguish that the multi-billion-dollar autism industry is perpetuating the same message that parents of fifty years ago were given: separate is more efficient.effective.better. It boggles my mind. Not just because all the new brick-and-mortar facilities, the special schools, are technically unlawful according to the Individuals with Disabilities Education Act (IDEA); but because few parents are questioning the wisdom of the social ostracism to which they are contributing.
Yes, yes, I’m aware that oftentimes parents feel they have no other alternative other than to special school, home school, cyber school. I know that people are weary of battling unyielding school districts. I “get” that kids with autism are routinely victimized, verbally and physically abused by peers and teachers in ways that are inconceivable in this day and age. But show me where segregation has been proven to be a good thing.
There is extraordinary danger in ignoring our past. There is also a danger in disbelieving that were are not caught up in the midst of a human rights movement every bit as viable and worthy as the advances achieved by women’s rights, civil rights, or gay rights activists.
It is not okay that millions of dollars are being funneled into establishing sparkling-new, attractively-equipped and professionally-staffed special schools. It’s not okay that we abstain our local school districts of the responsibility for educating children with autism everytime a frustrated parent pulls their kid out of school in pursuit of alternative education. And it is not acceptable that the autism industry continues to complicate and compromise the perspectives of educators such that they feel incompetent and unprepared to educate children.
According to the Los Angeles Times, California, alone, spent $320 million last year for “autism services,” up from $50 million a decade earlier. Nationwide, the tab is $90 billion annually, a figure expected to double in a decade. Autism services usually translates to “behavior therapy,” which means getting kids with autism to comply by behaving normally-”reducing inappropriate behavior”-instead of making compassionate accommodations by understanding that “behavior” is communication, and learning how to communicate and interact respectfully.
To be succinct, special schools wouldn’t exist if regular schools got it right. That should be the source of all autism educational funding: helping the regular schools to get it right so that segregation-and the prejudice and fear it breeds-is never again an option.
© 2008, William Stillman
William Stillman is speaker, consultant, self-advocate and author of numerous autism and special needs parenting books. His Website is www.williamstillman.com
Many need to homeschool
February 14, 2009
I liked this blog - it was very informative - particularly since we were almost faced with having no choice but homeschool our child.
http://autismsucksrocks.blogspot.com/2009/02/dirty-secret-schools-dont-want-you-to.html
Court says vaccines not to blame for autism
February 13, 2009
http://www.msnbc.msn.com/id/29160138/
I’m not surprised that this was the outcome. Instead of looking at thimerasol as the culprit, we need to start talking about the great amounts of vaccines that are given to young children. Pair that with the first-born toxic build-up theory (that I blogged about earlier) and there is something to look at. How hard is it to come up with a modified vaccine schedule?
More interesting research
February 12, 2009
Seeing color in sounds has genetic link
http://world-onlinex.blogspot.com/2009/02/seeing-color-in-sounds-has-genetic-link.html
Some research news
February 11, 2009
Case Western Reserve research finds that the lack of specific gene plays role in autism
http://esciencenews.com/articles/2009/02/09/case.western.reserve.research.finds.lack.specific.gene.plays.role.autism
So Matter of Fact
February 10, 2009
Another thing I find so refreshing about Aspergers is their matter-of-fact nature. Here’s one of the conversations today in my household:
my daughter “its stinky in here!”
my husband “did the dog poop in the house?”
my son “no I just had a bad fart because of the taco beans from last night.”
Grey’s Anatomy
February 9, 2009
Who has seen the new Grey’s Anatomy character - the doctor who apparently has Aspergers?
I don’t claim to be an expert on Aspergers by any means. But, I don’t see any similarities with this character and my son, or anyone that I know with Aspergers for that matter. I do know that one Aspergers isn’t the same as another’s Aspergers.
I have mixed feelings about this character on the show. On the one hand, I appreciate the fact that they are willing to showcase Aspergers on such a high profile show. I also appreciate the fact that this character is also a doctor, showing that people with Aspergers can be successful in life. On the other hand, the way they portray the doctors Aspergers doesn’t give anyone confidence in this doctors abilities.
I’m planning to check out the other blogs on this topic and I’ll report back what the general consensus is.
