(NIH Press release is at the end of this post.)
By Katie Wright
First of all let me tell you who is excluded from this $28 million autism research project.
Autistic people with epilepsy
Autistic people w sensory/ motor problems
Autistic people with Metabolic/ Mitochondrial abnormalities
Autistic people with environmentally triggered autism
Ok I think that just about rules out 75% of people with autism?
Just imagine a giant $28 million NIH on the heterogeneity of the HIV population. But the study excludes gay men, IV drug users and sex workers and is ONLY studying hemophiliacs. Absurd right? Yet that is exactly how half-witted this autism biomarkers project is designed.
Ostensibly the hypothesis is that research progress has been impeded by the heterogeneity of autism. OK, fair enough, so why not actually study a heterogeneous group of ASD people and compare those biomarkers? But no, the NIH biomarker project is studying healthy largely HF ASD people, period. Naturally this is the group of ASD people who least need medical science’s help – so start there of course!
One hears the words autism biomarkers and, naturally, thinks of tissue samples, autoantibodies, immunoglobulin levels, cytokine profiles, T cell count, oxidative stress levels….but no, incredibly, the NIH believes “face processing” is a biomarker. The NIH “Biomarker” project will be studying: eye tacking, face processing, pupil light reflexes, social communication, EEGs (more needless torture for ASD kids). Basically every single item on this list has already been studied 10,000 times. Let’s see, for example there are 455 published studies on autism and face processing.
Unfortunately my son has been through at least 5 EEGs, ranging from 24 hours to 5 days long. Honestly it is a nightmare. To do this unnecessarily is unethical and cruel. A team of people glue probes to the child’s scalp. This takes hours. Then the child must wear a giant bandage turban on their head so they do not touch the probes. Did I mention that during an EEG the patient is tethered to the hospital wall, essentially a 5-foot leash? OK, then imagine this angry, uncomfortable child trying to sleep. Finally when it comes time to end this horrible experiment, the removal of the EEG bandages and probes is worse than the application. The poor kid is crazed with a desire to break out of that room. The smell of glue is awful and glue from the probes is stuck to hair, making the removal painful.
After all this, nothing particularly actionable is discovered. I mean SO rarely. The EEG remains a crude instrument picking up only really big abnormalities, even with epilepsy.
So that is the big $28 million NIH Autism Project: face processing and torturous EEGs of healthy HF autistic people. Is it just me or is this an insane waste of money?
The whole “we are studying autism’s heterogeneity” silliness writes itself here. The project claims to be researching autism’s heterogeneity by studying 1 form of autism: healthy and relatively HF ASD people. The project asserts that scientists from many disciplines and perspectives are involved. Ok, I see a bunch of super conservative neurologists and radiologists from the “autism is all genetic” world. Then I see a dozen psychologists from the “learn the signs early diagnosis” world. This is about as diverse as a group of white men studying racial heterogeneity.
We needed the “learn the signs” research 15 or 20 yrs ago. But it is 2015, and 10,000 published studies on the subject later, we must move on. We know the signs of autism. Right now we need pediatricians to read the research and we need more services providers and shorter waiting lists. That would actually help.
I feel like it is really time to have the “there is no Santa Claus” talk with the autism research community, because early diagnosis is failing to significantly help most children with autism.
There is this fantasy that once we can diagnose 6-month-olds (never mind that 40% kids develop autism only after age 1), we can train them to be social and not autistic. It is so naïve! Tragically naïve. Honestly if the only intervention is behavioral treatment, early diagnosis doesn’t matter that much.
Dr. Debbie Fein’s research clearly shows that even with excellent early intervention only 17% of ASD toddlers lose their diagnosis. Whether a child is diagnosed at 18 months or 24 months barely makes a difference. Time to face reality. I know, I know lots of psychologists who created EI treatment always seem to find that their methods make a big difference. Sure, EI studies can show a big pre-and-post difference if you hand pick your subjects and they are largely moderately or mildly affected to begin with.
Ironically it is the extreme homogeneity of research study designers that doom the NIH ASD “Biomarkers” project to failure. This group of academics has no idea, outside of "learn the signs" and EEGs, what autism actually involves. If you look at the organizational chart of this project your head will spin. It is bureaucracy squared! There are about 50 people in charge but not one of them has GI, immunological, toxicological or environmental science expertise.
I don’t know if these people just do not want to succeed or if they don’t care that they keep failing? I do know that the NIH is exceedingly unambitious in ASD science. They settle for crumbs of progress and vigorously patting each other in the back in the progress. The researchers in this “Biomarker” are largely academics with little experience with the ASD community and almost none caring of an ASD person. Imagine if 50 men were running a PMS research project. This is just as harebrained.
Finally, I thought that IACC was supposed to guide NIH research choices, not the other way around. After choosing not to have an IACC meeting for over a year Dr. Cuthbert presents this enormously expensive NIH autism research project as a done deal -- with ZERO community input. I think there are maybe 2 ASD parents (naturally both are very conservative) involved in this gigantic project. The NIH developed this silly study in total isolation from ASD families (who do not want it) and voted to award their own researchers the project. Why bother having IACC at all? Does it just exist to rubber stamp the projects NIMH has already selected? The sense of entitlement towards the spending of taxpayer money with no outside input or accountability is appalling.
The NIH Autism “Biomarkers” Project is a preposterously foolish endeavor and a waste of our research money. Does anyone know anything about forensic auditing of taxpayer money? Is there a research recall process?
Katie Wright is Contributing Editor to Age of Autism.
About the study: Government, non-profit and other private partners will fund a multi-year project to develop and improve clinical research tools for studying autism spectrum disorder (ASD). The project will receive a total of $28 million over the next four years to test and refine clinical measures of social impairment in ASD in order to better evaluate potential behavioral and drug therapies. It is supported by the National Institutes of Health (NIH), the Foundation for the NIH (FNIH), the Simons Foundation Autism Research Initiative (SFARI), and others. NIH funding comes from the National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
The effort is the latest addition to the prestigious list of projects supported by the Biomarkers Consortium, a large public-private partnership that aims to accelerate biomedical research progress. James McPartland Ph.D. of Yale School of Medicine, New Haven, Connecticut, serves as principal investigator. The Consortium supports research to identify disease-specific biomarkers and develop targeted technologies and treatments. Its ultimate goal is precision medicine —an emerging approach to prevention and treatment that takes into account an individual’s disease-related variations in genes, environment, and lifestyle.
ASD is a group of neurodevelopmental disorders that affects social interaction and communication skills and can cause restricted and repetitive behaviors. Approximately 1 percent of children throughout the world have an ASD, each with his or her own unique combination of symptoms and levels of impairment. It is this extensive spectrum of symptoms and severity that has proven to be particularly challenging for clinical research.
“The heterogeneity in people with an ASD makes it imperative that we find more precisely diagnosed groups of research subjects so that we can objectively evaluate the clinical effects of an intervention,” said NIMH Director Thomas R. Insel, M.D. “This consortium project will develop reliable tools and measures that clinical researchers can use to assess potential treatments.”
McPartland and his team will conduct a multi-site study of preschool (3-5 years) and school aged (6-11 years) children, both with and without ASD, over the course of several months. Research sites include Yale University, Duke University, Durham, North Carolina, the University of California, Los Angeles, the University of Washington, Seattle, and Boston Children’s Hospital.
The research team will begin by comparing lab-based measures of domains of social impairment to commonly used, standardized clinician and caregiver assessments of social function. Specifically, they will investigate the sensitivity and reliability of these unique measures in terms of how well they indicate changes in a participant’s core social impairment symptoms over time.
The researchers will then evaluate the potential utility of eye tracking responses and measures of brain activity via electroencephalogram (EEG) as biomarkers for future clinical trials. They will investigate how these two noninvasive and relatively inexpensive biomarker measures relate to their recently validated lab-based measures of social function. Together, these findings will lay the groundwork for ASD researchers to objectively select meaningful subgroups of children and reliably measure the clinical effects of interventions.
In addition to the behavioral measures and biomarker data, this community resource will also include blood samples from subjects and their parents for use in future genetic studies. Data and resource sharing are key components of this Consortium project. All data generated in the project will be made available for other researchers to view and analyze through the NIH-funded National Database for Autism Research and the NIMH Repository and Genomics Resource .
More information on the project may be found at www.asdbiomarkers.org .
About the National Institute of Mental Health (NIMH): The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit the NIMH website.
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): The NICHD sponsors research on development, before and after birth; maternal, child, and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the NICHD website.
About the National Institute of Neurological Disorders and Stroke: (NINDS) is the nation’s leading funder of research on the brain and nervous system. The NINDS mission is to reduce the burden of neurological disease – a burden borne by every age group, by every segment of society, by people all over the world. For more information, visit the NINDS website .
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit the NIH website .