Autism Speaks Announces New Clinical Trials Network Study
Trial Seeks to Confirm Efficacy of New Formulation of Fluoxetine in Reducing Certain Core Symptoms of ASD in Children and Adolescents
NEW YORK, NY (July 5, 2007) — Autism Speaks, the largest non-profit organization dedicated to increasing awareness of autism and raising money to fund autism research, today announced that its Clinical Trials Network (CTN) is launching a new study in collaboration with specialty pharmaceutical company Neuropharm Group Plc.
The trial, known as SOFIA (Study of Fluoxetine in Autism), will include more than 100 children and adolescents with Autism Spectrum Disorders (ASD) to confirm the effectiveness of Neuropharm’s custom-designed product NPL-2008, a proprietary preparation of fluoxetine, in reducing certain core symptoms of ASD. This new formulation will feature autism-specific doses in a melt-in-the-mouth formulation designed specifically for those with ASD.
Fluoxetine, one of the most widely prescribed central nervous system (CNS) drugs, is a selective serotonin reuptake inhibitor (SSRI) often prescribed to treat depression, anxiety, obsessive-compulsive disorder and other CNS disorders. Fluoxetine is designed to increase serotonin levels in the brain and may therefore address symptoms related to abnormal levels of serotonin observed in individuals with ASD.
This collaborative study, which represents the CTN’s first industry-sponsored trial, will provide Neuropharm with access to Autism Speaks’ CTN network of 12 specialist pediatric centers and key opinion leaders.
The SOFIA trial follows positive results from earlier Phase II and Phase III studies of fluoxetine in children and adults with autism, conducted by Professor Eric Hollander at Mount Sinai School of Medicine in New York.
“This partnership maximizes the utility of our network of CTN sites, which offers the private sector a mechanism for expediting drug trials in collaboration with clinicians and researchers who are experts in both pediatric psychopharmacology and ASD,” said Dr. Clara Lajonchere, Autism Speaks’ Vice President of Clinical Programs.
Autism is a complex brain disorder that inhibits a person’s ability to communicate and develop social relationships, and is often accompanied by extreme behavioral challenges. Autism Spectrum Disorders are diagnosed in one in 150 children in the United States, affecting four times as many boys as girls. The diagnosis of autism has increased tenfold in the last decade. The Centers for Disease Control and Prevention have called autism a national public health crisis whose cause and cure remain unknown.
About Autism Speaks
Autism Speaks is dedicated to increasing awareness of autism spectrum disorders, to funding research into the causes, prevention, treatments and cure for autism, and to advocating for the needs of affected families. It was founded in February 2005 by Suzanne and Bob Wright, the grandparents of a child with autism. Bob Wright is Vice Chairman, General Electric, and served as chief executive officer of NBC for more than twenty years. Autism Speaks has merged with both the National Alliance for Autism Research (NAAR) and Cure Autism Now (CAN), bringing together the nation’s three leading autism advocacy organizations. To learn more about Autism Speaks, please visit www.autismspeaks.org.
Autism Speaks is also active in the UK, where the local charity is chaired by long-standing autism advocate and philanthropist Dame Stephanie Shirley. Autism Speaks in the UK collaborates with its sister charity on autism awareness and research. To learn more about the work of Autism Speaks in the UK, please visit www.autismspeaks.org.uk.
About the Clinical Trials Network
The Autism Speaks Clinical Trials Network (CTN) was launched by Cure Autism Now in 2005 to focus on translational research, the critical step necessary to transfer findings from the laboratory to clinical application. Well-controlled and appropriately blinded studies are necessary to test whether anecdotal evidence holds. By facilitating data-sharing and multi-center trials, the goal of the network is to test the efficacies of treatment approaches as well as to rapidly screen new promising compounds that emerge from biomedical research, significantly decreasing the time and amount of money needed to develop them. The CTN approach enables multiple sites to enroll children around the country, therefore reaching recruitment goals in a much shorter amount of time than any single site could complete on its own.
About Neuropharm Group Plc
Neuropharm Group Plc is a UK specialty pharmaceutical company focused on the development of products for the treatment of disorders of the central nervous system. For more information, please visit www.neuropharm.co.uk.
Autistic people have fought the inclusion of ABA in therapy for us since before Autism Speaks, and other non-Autistic-led autism organizations, started lobbying legislation to get it covered by insurances and Medicaid.
ABA is a myth originally sold to parents that it would keep their Autistic child out of an institution. Today, parents are told that with early intervention therapy their child will either be less Autistic or no longer Autistic by elementary school, and can be mainstreamed in typical education classes. ABA is very expensive to pay out of pocket. Essentially, Autism Speaks has justified the big price tag up front will offset the overall burden on resources for an Autistic’s lifetime. The recommendation for this therapy is 40 hours a week for children and toddlers.
The original study that showed the success rate of ABA to be at 50% has never been replicated. In fact, the study of ABA by United States Department of Defense was denounced as a failure. Not just once, but multiple times. Simply stated: ABA doesn’t work. In study after repeated study: ABA (conversion therapy) doesn’t work.
What more recent studies do show: Autistics who experienced ABA therapy are at high risk to develop PTSD and other lifelong trauma-related conditions. Historically, the autism organizations promoting ABA as a cure or solution have silenced Autistic advocates’ opposition. ABA is also known as gay conversion therapy.
The ‘cure’ for Autistics not born yet is the prevention of birth.
The ‘cure’ is a choice to terminate a pregnancy based on ‘autism risk.’ The cure is abortion. This is the same ‘cure’ society has for Down Syndrome.
This is eugenics 2021. Instead of killing Autistics and disabled children in gas chambers or ‘mercy killings’ like in Aktion T4, it’ll happen at the doctor’s office, quietly, one Autistic baby at a time. Different approaches yes, but still eugenics and the extinction of an entire minority group of people.
Fact: You can’t cure Autistics from being Autistic.
Fact: You can’t recover an Autistic from being Autistic.
Fact: You can groom an Autistic to mask and hide their traits. Somewhat. … however, this comes at the expense of the Autistic child, promotes Autistic Burnout (this should not be confused with typical burnout, Autistic Burnout can kill Autistics), and places the Autistic child at high risk for PTSD and other lifelong trauma-related conditions.
[Note: Autism is NOT a disease, but a neurodevelopmental difference and disability.]
Fact: Vaccines Do Not Cause Autism.