Archive | NIH RSS feed for this section

Clinical trial on Clinical and Immunological Investigations of Subtypes of Autism

24 Mar

The National Institutes of Health (NIH) have recently updated their webpage of featured clinical trials for autism. Many of the clinical trial recently discussed here at LeftBrainRightBrain are on that list. One that is on the featured list that I caught my eye is Clinical and Immunological Investigations of Subtypes of Autism. It is an old trial (started in 2006), but I thought it worth bringing up again.

The description is quoted below:

The purpose of this study is to learn more about autism and its subtypes. Autism is a developmental disorder in which children have problems with communication and social skills and display restricted interests and repetitive behaviors.

This study has several goals. One aim is to look at types of autism that are known, such as the regressive subtype, (where skills are lost). We will explore whether there is a unique change in immune functioning related to this subtype. Another aim is to serve as one of the sites that will pilot a larger natural history study, entitled Autism Phenome Project. The goal is to further understand autism by identifying other subtypes.

We will look at several types of medical issues that may be related to autism, including immunologic problems. Children will be followed over the course of several years. We aim to capture medical problems that may be related to autism as they develop, and study outcomes in areas such as behavior and language, in order to explore known and new subtypes of autism.

Normally developing children (aged 1) with autism (age 1, and developmental delays other than autism (age 1), may be eligible for this study.

Depending on each child’s study group and age, participants may undergo the following tests and procedures:

Baseline Visit

* Medical and developmental history, physical examination, psychological, cognitive and medical tests to assess symptoms of autism or other developmental disorders, photographs of the child’s face, collection of hair, urine and baby teeth samples. If available, hair samples from the baby’s first haircut and from the biological mother’s hair are also collected.
* Overnight electroencephalogram (EEG): A special cap with electrodes is placed on the child’s head to measure brain waves (brain electrical activity) while the child sleeps in the hospital overnight. Healthy volunteers do not undergo this procedure.
* Magnetic resonance imaging (MRI) scan: The child stays in the scanner, lying still for 10 to 15 minutes at a time. Since it may be difficult for the child to lie still, the test may be scheduled for a time when the child is likely to be sleepy, or the child may be sedated.
* Lumbar puncture (for children in the autism). This test and the MRI may be done under sedation.

Follow-Up Visits

Follow-up visits are scheduled at different intervals, depending on study group, age and aspect of the study the child is enrolled in. The visits include a short interview session with the child’s caregiver and assessment of the child’s development and behavior. Some of the assessment measures used during the baseline examination are repeated, including symptoms ratings, behavioral tests and a blood test. For some children, the final visit will include repeats of the medical procedures.

The section that jumps out to my eye: We will explore whether there is a unique change in immune functioning related to this subtype. Another aim is to serve as one of the sites that will pilot a larger natural history study, entitled Autism Phenome Project. The goal is to further understand autism by identifying other subtypes.

Yes, the NIH is looking at whether regression and immune functioning might be linked. As noted above, this study has been ongoing for some time: the trial was first listed in 2006. But, hey, I figure if I forgot about this one and found it interesting, others might be interested in this as well.

Clinical trial of Donepezil for improving REM sleep in autistic children

23 Mar

A recent lecture I heard discussed how as many as 25% of autistic children get little or no REM (rapid eye movement) sleep. REM sleep is an important sleep phase and it is thought this could contribute to cognition and behavior problems in these children.

Anecdotally (and probably confirmed by studies is my guess) many autistic children have sleep problems. Children are reported to sleep fewer hours, have problems getting to sleep and wake up in the middle of the night. This new result, to me at least, is the first I’ve heard of reduction or lack in REM sleep.

In response to this finding, a clinical trial is underway to study the use of Donepezil (Aricept) with autistic children.

The clinical trial description is:

Detailed Description:

Autism spectrum disorders are defined by aberrant development of communication and socialization in the presence of restrictive and/or repetitive behaviors. Recent epidemiologic studies have documented an increase in the number of children identified with autism spectrum disorder over the past decade and according to some, the current numbers indicate a prevalence of 1 per 150 (CDC, MMWR 2007, Feb 9th release). Despite the pressing need to identify causal factors, etiology remains elusive. Furthermore, the heterogeneity of presentation complicates attempts to locate autism’s home in the brain.

Polysomnography is a reliable non-invasive tool that can be used to study the basic pathophysiological mechanisms of autism and other developmental and neuropsychiatric disabilities. Our preliminary data in young children with autism supports a growing body of literature demonstrating that sleep architecture is abnormal in this disorder. Previous studies in children with autism have identified various abnormalities in REM sleep including the following: immature organization, decreased quantity, abnormal twitches, undifferentiated sleep and REM sleep behavior disorder characterized by the absence of the muscle atonia that is normal in REM sleep and resulting in an acting out of dreams phenomenon (Tanguay et al ,.1976, Elia et al., 2000, Diomedi et al. 1999, and Thirumalai et al., 2002).

Our cohort spent an abnormally short time in the REM sleep stage of sleep compared to total sleep time (hereafter referred to as SPT REM% for REM sleep as a percent of sleep period time), and had a prolonged latency to REM sleep. The function of REM sleep and its relationship to cognition and overall neurological health is unknown and a subject of ongoing research. We know from animal studies that REM sleep increases after intensive learning sessions. These laboratory findings formed the basis for the hypothesis that this sleep stage is important for cognitive processes and that REM sleep may be useful as an indicator of brain plasticity. Current studies continue to add support for this idea. REM sleep has most recently been implicated in the process of human memory consolidation and several studies suggest that it is crucial to normal cognitive function and in the processing of emotion in memory systems. Acetylcholine (Ach) is one of the major neurotransmitters necessary for normal sleep transitions and abnormalities in Ach have been implicated in REM deficient sleep in other populations, most notably Alzheimer’s disease.

This proposal is for a 6 to 20 week, single arm, open-label study to evaluate the ability of donepezil hydrochloride to enhance REM sleep in children with autism spectrum disorder found to have a low SPT REM% (defined as below 2 standard deviations of observed normative data for age). All patients will come through the screening protocol 06-M-0065. Those who meet a research diagnosis of autism spectrum disorder and are ages 2 to 11 (through the tenth year) will be evaluated for inclusion/exclusion criteria for the study.

The primary outcome measure of this protocol is to increase the SPT REM% in children with autism such that their REM/non-REM ratios begin to approach normative values. Donepezil enhanced REM sleep has been achieved in young healthy adults, in elderly, healthy adults and in elderly, demented adults with Alzeheimer’s disease. Furthermore, the studies in Alzheimer disease by Mizuno et al showed a positive correlation between improved cognition and increased SPT REM %. If REM sleep is necessary for normal cognition, and its deficiency or absence can be remedied by pharmacologic intervention, then it may follow that improvement of REM sleep correlates with improved short and long term cognition in children with autism. Donepezil enhanced REM sleep has not been documented in children. Polysomnography provides a non-invasive tool to assess the effects of enhancing cholinergic tone on the abnormal sleep architecture we have documented in our pediatric, autistic population.

My guess is that some are thinking, “why look at this drug when many already use melatonin to help autistic children sleep”. After all, Aricept is an Alzheimer’s drug, with little study in children.

OK, I admit I did. So I did a quick search and found that melatonin has not been found to increase REM sleep.

Aside from my reservations about giving an Alzheimer’s drug to 2 year olds, this is the type of clinical trial I like to see. A clear question is presented that is supported by data. A clear outcome (increased REM sleep) is measurable. Secondary outcomes, improved cognition and behavior, are also measurable and defined.

Does The NIH Want To Study Jenny McCarthy’s Son?

22 Mar

Why would the National Institutes Of Health want to study Jenny McCarthy’s son?

Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers.

Jenny McCarthy seems to have pretty much claimed she cured her son’s autism.

Yeah, I know, she’s apparently claimed a lot of stupid things though:

You know, I could in two months turn Evan completely autistic again. I could do it completely through diet. And maybe getting some vaccine boosters.

I really can’t keep up with Jenny McCarthy’s anti-vaccination and autism nonsense.

If you’re one of those types who’s attracted to McCarthy’s silliness like many are to a car accident, but are smart enough to just keep driving and later try to catch a thumbnail report of what much of the nonsense seems to be about, I recommend reading Kev’s recent piece in response to an article of hers in the Huffington Post.

An Open Letter To Jenny McCarthy

In that Huffington Post article, she wrote the following:

Parents of recovered children, and I’ve met hundreds, all share the same experience of doubters and deniers telling us our child must have never even had autism or that the recovery was simply nature’s course. We all know better, and frankly we’re too busy helping other parents to really care.

Uh huh.

And remember when Jenny McCarthy wrote this a couple of years ago at a CNN blog?

Evan is now 5 years old and what might surprise a lot of you is that we’ve never been contacted by a single member of the CDC, the American Academy of Pediatrics, or any other health authority to evaluate and understand how Evan recovered from autism. When Evan meets doctors and neurologists, to this day they tell us he was misdiagnosed — that he never had autism to begin with. It’s as if they are wired to believe that children can’t recover from autism.

So where’s the cavalry? Where are all the doctors beating down our door to take a closer look at Evan? We think we know why they haven’t arrived. Most of the parents we’ve met who have recovered their child from autism as we did (and we have met many) blame vaccines for their child’s autism.

Source (and emphasis mine)

Autism research was being funded and conducted by U.S. “health authorities” long before Jenny McCarthy entered and re-entered the public eye (rebranded from IndigoMoms.com to Generation Rescue back sometime between 2006 and 2008), of course. But I suppose it’s quite possible they weren’t interested in stories like Jenny’s. That’s apparently a thing of the past (and so should be McCarthy’s claim that they aren’t interested).

While it might not meet McCarthy’s apparent expectation of a personal contact, indeed the NIH is interested in the subject.

Identification of Characteristics Associated With Symptom Remission in Autism

Additional detail here.

This study has apparently been listed since June, and it’s still recruiting!

LBRB blogger, Sullivan, noted this not too long ago:

NIH to study recovered autistics

He had an interesting observation too:

This is a study that should be done, in my opinion. I will note that this study has supposedly been one of the key pieces being sought by multiple parent groups. I will further note that I have not seen any of them mention this study. Quite the opposite, in fact. I see comments occasionally on blogs about how their frustration that such a study is not being performed. Perhaps I missed it, but I am curious why their leadership doesn’t make a big deal out of this.

To repeat, a component of this study (which is also looking at other possible reasons for remission) is looking for Jenny McCarthy:

Similarly, there are a large number of anecdotal reports of children with autism who, following intensive biomedical intervention (e.g., gluten/casein free diets, vitamin supplements, chelation), are indistinguishable from their typically developing peers.

The Sponsor and Researcher for this study? The NIH.
(Note to Jenny: that’s a “Health Authority: United States: Federal Government”)

They’re looking for Jenny. They want to hear her/Evan’s story (they’ll want substantiating detail too, but that won’t be a problem).

I wonder how many of the “Rescue Angels” or other AoA followers have signed up to participate? Did Jenny McCarthy get the word out to her people? I’m sure she did, right? Like Sullivan, did I miss it too? I could have.

If you don’t think she might have, and if you know Jenny McCarthy (cause lord knows, I don’t), please make sure she gets this info:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Proposed HHS budget has $16M more funding for autism research

21 Feb

The United States Department of Health and Human Services is proposing an increase in autism research funding of $16 million, or about 8% over the 2010 budget:

Addressing Autism Spectrum Disorders: The Budget includes $222 million, an increase of $16 million, for Autism Spectrum Disorders (ASD). NIH research will pursue comprehensive and innovative approaches to defining the genetic and environmental factors that contribute to ASD, investigate epigenomic changes in the brain, and accelerate clinical trials of novel pharmacological and behavioral interventions. CDC will expand autism monitoring and surveillance and support an autism awareness campaign. HRSA will increase resources to support children and families affected by ASD through screening programs and evidence-based interventions.

The Obama administration had originally projected $210M by 2011, so if this gets approved they will be ahead of the original plan.

Last year the Obama administration proposed $211 million:

Supports Americans with Autism Spectrum disorders (ASd). The President is committed to expanding support for individuals, families, and communities affected by ASD. The Budget includes $211 million in HHS for research into the causes of and treatments for ASD, screenings, public awareness, and support services.

If I do my sums correctly, congress actually funded $206 million. Don’t be surprised if the amount funded for 2011 is less than the $222 million proposed. Then again, according to Jocelyn Kaiser at Science:

And in any case, the president’s budget proposal doesn’t mean much because Congress usually ends up giving NIH more than the president requests.

The budget mentions autism in other places:

INVESTING IN SCIENTIFIC RESEARCH AND DEVELOPMENT
Exploring Scientific Opportunities in Biomedical Research:
The Budget includes $32.2 billion for NIH, an increase of $1 billion, to support innovative projects from basic to clinical research. This effort will be guided by NIH’s five areas of exceptional research opportunities: supporting genomics and other high-throughput technologies; translating basic science into new and better treatments; reinvigorating the biomedical research community; using science to enable health care reform; and focusing on global health. The Administration interest for the high-priority areas of cancer and autism fits well into these five NIH theme areas. In FY 2011, NIH estimates it will support a total of 37,001 research project grants, including 9,052 new and competing awards.

Emphasis added.

also,

Autism and Other Developmental Disorders: The Budget requests $55 million, an increase of $7 million, as part of the President’s Initiative to support children with autism spectrum disorders and their families. This funding will continue to expand Federal and State programs authorized in the Combating Autism Act to research, and support screening and vidence-based interventions when a diagnosis is confirmed.

also,

National Vaccine Injury Compensation Program: The Budget requests $7 million for the Vaccine Injury Compensation Program to prepare for projected increases in claims and continue reviews of over 5,100 claims from autism proceedings.

also, under ADDRESSING RESEARCH PRIORITIES IN FY 2011:

In FY 2011, for autism spectrum disorders, again building on significant Recovery Act investments, NIH will undertake complete genome sequencing and comprehensive DNA analyses of 300 autism spectrum disorder cases, and will launch the first epigenomic studies of brain samples from individuals with and without autism. NIH will also use a network of health maintenance organizations to identify patterns of environmental exposure during pregnancy and perinatal life that may contribute to autism.

and,

In FY 2011, NIH will also accelerate Phase 3 clinical trials of a promising mGluR5 antagonist, begin a clinical trial of the drug rapamycin, and create a translational pipeline for advancing additional small molecule drugs for autism.

Would I like to see more funding applied to autism? Heck yeah. But, this is twice the commitment that the previous administration made in autism research.

The proposed budget continues the NIH commitment to research on environmental and gene-environment causation of autism.

IACC calls for $175 million in autism and the environment research

5 Feb

The Interagency Autism Coordinating Committee has posted the revised Strategic Plan. I blogged it recently here on LeftBrainRightBrain. I made a note of the large commitment to environmental causation research. I thought it worthwhile to highlight that section, since this is the cause of so much criticism of the IACC.

Strangely, the criticism doesn’t come from those who are supposedly “It’s all genetic” types. No, the “it’s all environmental” groups seem to be very loud in complaining that all the research funding is going into genetics.

The Plan is divided by a number of questions. Research into causation is listed in Question 3: “What Caused This To Happen And Can This Be Prevented?”

Under that category, there are seven projects on environmental or gene-environment research. Seven out of 10 projects. The estimated budget for all these projects? $175,900,000.

In other words, 70% of the projects and, if I did my math right, nearly 70% of the funding for causation is estimated to be going to environment and gene-environment projects.

This would seem like a great victory for those who have lobbied for more environmental research. I have yet to see anyone from that group even mention the new Strategic Plan, much less the large commitment to environmental research. Where are the statements from SafeMinds (who have a very vocal member who sits on the IACC proper and another who is on a working group)? How about Generation Rescue? The National Autism Association?

In my opinion, these groups really don’t care much about environmental causation unless it is either mercury or vaccines. Hey, I could be wrong. Let’s see if they surprise me with some acknowledgment of this effort by the US Government.

Here are the objectives if you would like to read for yourself.

Short-Term Objectives

1. Coordinate and implement the inclusion of approximately 20,000 subjects for genome-wide association studies, as well as a sample of 1,200 for sequencing studies to examine more than 50 candidate genes by 2011. Studies should investigate factors contributing to phenotypic variation across individuals that share an identified genetic variant and stratify subjects according to behavioral, cognitive, and clinical features. IACC Recommended Budget: $43,700,000 over 4 years.
2. Within the highest priority categories of exposures for ASD, identify and standardize at least three measures for identifying markers of environmental exposure in biospecimens by 2011. IACC Recommended Budget: $3,500,000 over 3 years.
3. Initiate efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene – environment research by 2011. IACC Recommended Budget: $27,800,000 over 5 years.
4. Enhance existing case-control studies to enroll racially and ethnically diverse populations affected by ASD by 2011. IACC Recommended Budget: $3,300,000 over 5 years.
5. New objective
Support at least two studies to determine if there are subpopulations that are more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying autoimmune problems) by 2012. IACC Recommended Budget: $8,000,000 over 2 years.
6. New objective
Initiate studies on at least 10 environmental factors identified in the recommendations from the 2007 IOM report “Autism and the Environment: Challenges and Opportunities for Research” as potential causes of ASD by 2012. Estimated cost $56,000,000 over 2 years.

Long-Term Objectives

1. Conduct a multi-site study of the subsequent pregnancies of 1,000 women with a child with ASD to assess the impact of environmental factors in a period most relevant to the progression of ASD by 2014. IACC Recommended Budget: $11,100,000 over 5 years.
2. Identify genetic risk factors in at least 50% of people with ASD by 2014. IACC Recommended Budget: $33,900,000 over 6 years.
3. Determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development by 2015. IACC Recommended Budget: $25,100,000 over 7 years.
4. Support ancillary studies within one or more large-scale, population-based surveillance and epidemiological studies, including U.S. populations, to collect data on environmental factors during preconception, and during prenatal and early postnatal development, as well as genetic data, that could be pooled (as needed), to analyze targets for potential gene/environment interactions by 2015. IACC Recommended Budget: $44,400,000 over 5 years.

Read more: https://leftbrainrightbrain.co.uk/2010/02/iacc-strategic-plan-is-up/#ixzz0edI3Pe8h

Recovery Act Funds Support Strategic Goals for Autism Research

9 Nov

The National Institutes of Health were given a large amount of money as a part of the economic stimulus package.

I just got the email below from the NIH autism listserve and thought some people reading here would be interested:

_____________________________
The National Institutes of Health (NIH) awarded more than 50 autism research grants, totaling more than $65 million, which will be supported with American Recovery and Reinvestment Act (Recovery Act) funds. These grants are the result of the largest funding opportunity for research on autism spectrum disorders (ASD) to date, announced in March 2009.

Awards were based on the quality of the proposed study and how well it addressed short-term research objectives detailed in the Interagency Autism Coordinating Committee’s (IACC’s) Strategic Plan for Autism Spectrum Disorder Research.

“These studies currently hold the best promise of revealing what causes autism, how it might be prevented, what treatments are effective, and how service needs change across the lifespan-questions noted in the IACC strategic plan as critically important to improving the lives of people with ASD and their families. The Recovery Act funding makes it possible to do the type of innovative research necessary to find these answers more quickly,” said Thomas R. Insel, M.D., director of the National Institute of Mental Health (NIMH), part of NIH, and IACC chair.

Examples of awarded studies include:

· Catherine Lord, Ph.D., of the University of Michigan, and Somer Bishop, Ph.D., of the Children’s Hospital Medical Center in Cincinnati, will lead a two-site study to adapt the Autism Diagnostic Interview-Revised-the current gold standard for diagnosing autism-into a brief parent interview that can be done over the telephone. This new tool will help reduce research screening costs and help researchers to quickly identify potential participants for ASD studies.

· David Amaral, Ph.D., Sally Rogers, Ph.D., and Judy Van de Water, Ph.D., all of the University of California Davis, aim to expand on a previous pilot program to identify different subtypes of autism based on behavioral, biochemical, and brain imaging markers. This research may help improve future efforts to study, diagnose, and treat children based on their subtype of autism.

· Joseph Buxbaum, Ph.D., of Mount Sinai School of Medicine; Richard Gibbs, Ph.D., of Baylor College of Medicine; Gerard Schellenberg, Ph.D., of the University of Pennsylvania; James Sutcliffe, Ph.D., of Vanderbilt University; and Mark Daly, Ph.D., of the Broad Institute at MIT; will lead a collaborative network of research labs and centers using cutting-edge technologies to discover specific genes underlying autism. Their research will provide insight into the biology of autism and expose genes and pathways that constitute high priority targets for the development of novel treatments.

· Sally Rogers, Ph.D., and Laurie Vismara, Ph.D., both of the University of California Davis, aim to develop and test a parent-delivered preventive intervention for infants 6-11 months old who are at high risk of developing ASD because they have an older sibling with the disorder. The intervention will focus on reducing atypical behaviors and developmental delays to help lessen or prevent the disabling symptoms associated with ASD.

· Olga Solomon, Ph.D., of the University of Southern California, will lead a study on how race, gender, socio-economic status, family culture, and communication during clinical encounters affect the health care experiences of African American children with ASD in an urban setting. Such research may help reduce the existing disparities in ASD diagnosis and service delivery for this and possibly other underserved populations.

· Ruth Carper, Ph.D., of the University of California San Diego, seeks to fill a gap in scientific understanding of the effects of ASD in later life. By exploring age-related changes in cognition and possible protective factors, as well as the changing service needs and quality of life concerns among adults and older people with ASD, this project may reveal targets for intervention and inform public policy.

· Rob McConnell, M.D., of the University of Southern California, and colleagues will explore possible links between traffic-related air pollution and ASD risk. They will also examine genes that help process pollutants in the body among children with and without autism to determine how these genes may affect ASD risk.

· Steven Camarata, Ph.D., and Mark Thomas Wallace, Ph.D., both of Vanderbilt University, will evaluate the effects of “sensory integration treatment” on communication and social skills in children with ASD. Based on desensitization techniques, this widely used but little studied treatment is believed to help reduce children’s resistance to outside stimuli and improve the integration of sensory information.

In addition to the contributions of direct findings from these studies, much of the data will also be available to other researchers through the National Database for Autism Research (NDAR). As a tool for the autism research community to exchange research related information, this use of NDAR is likely to advance the understanding of ASD heterogeneity to a far greater degree and at a more rapid pace than would be possible through any single project.

The grants will be administered by the five NIH Institutes that currently fund autism research: the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), and the National Institute of Neurological Disorders and Stroke (NINDS), with NIMH taking the lead on this effort and providing more than half of the total funds. This effort is included in the $5 billion in grant awards for biomedical research supported through the Recovery Act during FY 2009, as announced by President Obama during his visit to NIH on September 30, 2009.

The war on Tom Insel and the IACC

23 Oct

Tom Insel is director of the National Institute of Mental Health (NIMH) but he is better known to readers of this blog as the chair of the Interagency Autism Coordinating Committee. If you read other autism blogs, he’s probably very well known to you, as he has been the target of a concerted attack from the vaccines-cause-autism groups for a few months now. They even got the publicist, David Kirby, to take their battle to the public in a CBS interview.

Let me take a moment to make a side point. The vaccines-cause-autism groups (SafeMinds, Generation Rescue, the National Autism Association, Talk About Curing Autism (TACA)…I’m probably missing one or two), are basically a single consortium as evidenced by their single blog and their shared membership. I don’t see the need to treat them as separate entities. I really don’t see that they should be given multiple representations on the IACC.

I’ve been watching the IACC pretty closely for some time. I’ve also been watching the vaccines-cause-autism consortium. I’ve been watching the consortium build pressure against Dr. Insel.

One thing I’ve noticed: this level of pressure directed at Dr. Insel wasn’t always the case. Less than a year ago, Dr. Insel was not their target.

Take a look at one of the classic pieces of IACC intimidation: a piece called “Grinkers Stinker“. This is dated January, 2008. It was timed to coincide with a 4-day workshop that was the kick-off for the Strategic Plan process.

“Grinker’s Stinker” was a piece about the Dr. Joyce Chung, the former IACC coordinator. She is the wife of Prof. Roy Richard Grinker, anthropologist and author of the book Unstrange Minds. Dr. Grinker has publicly stated that he accepts the scientific consensus that vaccines did not cause an epidemic of autism. Dr. Chung has made no public statements (at least that I can find), but the lack of actual information about her or her opinions didn’t stop a blog post decrying her position on the IACC. From the blog post:

Does Joyce Chung agree with her husband? Did they ask her this question before she took the job?

Oddly, the last comment to that blog piece, by Generation Rescue’s “DC Liason” Kelli Ann Davis, starts with the question, “Can I suggest that we try and put an end to all the mudslinging?”

History has proven that, no, the Age of Autism can’t put an end to the mudslinging. Unfortunate, that.

Take a look at the blog post. There is no mention of Dr. Insel. No one decrying his “lack of leadership”, no one claiming “collusion” or “malfeasance”. None of the mudslinging terms currently used against members of the IACC, especially Dr. Insel. In fact, the first mention of Dr. Insel is in the comment by Ms. Davis. In her comment Ms. Davis suggests that Dr. Insel will be watching out for conflicts of interest.

Times certainly have changed. The Age of Autism likes to demonize those it disagrees with, and Dr. Insel certainly has been a recent target.

What happened?

Dr. Insel (a) had the IACC reconsider an initiative to call for a vaccine-autism study to be included in the Strategic Plan and (b) spoke before a congressional hearing about why vaccine/autism studies are not a high priority.

Not surprising to many of the readers here, I am sure, the vaccines-cause-autism consortium have a single issue (vaccines). As long as Dr. Insel’s position on vaccine/autism research, there was hope for the consortium and they left him alone. Once his current opinion formed and was public, he was public enemy number one. Yes, Dr. Paul Offit (vaccinologist and outspoken critic of the notion that vaccines cause autism) has been superseded.

Recently, Dan Olmsted (owner of the Age of Autism website) called for Dr. Insel to resign. Again, it boils down to the single issue: vaccines.

So, here we are. The vaccines-cause-autism consortium has declared war on Tom Insel for opposing their single-item agenda. If you think “war” is too strong a word, take it up with Mr. Olmsted. In referring to the recent incident where notes from an IACC member were made public:

…notes dropped on the floor (see the notes here) at the IACC, recovered by friendly forces and reported on our blog…

Yes, the Age of Autism people are “friendly forces”.

Here’s my perspective on Dr. Insel, for whatever it may be worth. He is the chair of the IACC. In my opinion, his role is to run the meetings and manage the staff. He should be getting good people in to serve on the IACC and the subcommittees and good people to consult on the topics that are discussed. Basically, his role is that of a facilitator–get good people together with the tools they need to do their job. He needs to be knowledgeable enough on the subject (autism) to do this.

You know what? Given the fact that his full time job is director of the NIMH, he’s actually done a pretty good job.

Is there room for improvement? Heck yeah. How about putting a greater emphasis on research into the needs of autistic adults? The majority of autistics are adults. And yet only 5% of the funding is being applied to this critical area.

But, of course, the squeaky wheels (the vaccines-cause-autism consortium in this case) get the grease. The squeaky wheels have been calling for research into environmental causes of autism. Tens of millions of dollars are being focused on this. Why are the squeaky wheels unhappy? Because the squeaky wheels didn’t really mean “environmental causes”. That was only a code word for vaccines.

This level of tension is not just sad. It is detrimental to the progress of the IACC. There are a lot of autistics, parents, professionals and organizations who are interested in working with the IACC. Why spend any more effort on the groups that have declared war?

(note, I made a number of changes in this piece shortly after publishing it)

It’s time to stop the intimidation tactics towards the IACC

21 Oct

The Interagency Autism Coordinating Committee (IACC) is group of government employees and autism community stakeholders who are chartered with coordinating research activities within the U.S. government’s Department of Health and Human Services (HHS).

The official charter is:

The Interagency Autism Coordinating Committee (Committee) shall coordinate all efforts within the Department of Health and Human Services concerning autism spectrum disorder to combat autism through research, screening, intervention and education. The Committee’s primary mission is to facilitate the efficient and effective exchange of information on autism activities among the member agencies, and to coordinate autism-related programs and initiatives. The Committee will serve as a forum and assist in increasing public understanding of the member agencies’ activities, programs, policies, and research, and in bringing important matters of interest forward for discussion.

The IACC predates the Combating Autism Act (CAA), but has taken on the role of coodination and strategic planning for the CAA.

This is no small effort. We are talking about a group that helps to set the goals for about $100M in research funding a year. The U.S. government’s research efforts into autism are the largest in the world. The research portfolio covers causation through supports for autistic adults.

I don’t think I will surprise anyone when I say that the autism communities, like any communities, have many different ideas of what focus should be placed on autism research. I would also expect little argument that the loudest voice in that discussion comes from the groups promoting the notion that vaccines caused an autism epidemic. Most of these groups are sponsors of the Age of Autism blog.

These groups lobbied hard to get vaccine research included in the Combating Autism Act. The failed. They did manage to get some senators to mention vaccines in the “colloquy“. These were statements made by senators when the Act was passed. Basically, these are speeches, not law. These statements were also not very strong. Consider this statement by Senator Enzi:

However, I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder. Thus, I hope that the National Institutes of Health will consider broad research avenues into this critical area, within the Autism Centers of Excellence as well as the Centers of Excellence for Environmental Health and Autism. No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.

The strongest argument that can be made is that three senators made a nonbinding statement that the National Institutes of Health should “consider” research on vaccines.

The Combating Autism Act was signed over three years ago. Since that time it has become even more clear that vaccines are not a primary cause of autism. The two major theories that the MMR vaccine or that Thimerosal cause autism have been shown to have very little scientific basis. Both were discussed at length in the Autism Omnibus Proceedings. The MMR causation theory has already been rejected as “not even close” and upheld by three separate appellate judges. The thimerosal theory has not been decided as yet, but the science was no better than that used for MMR. I expect that the Thimerosal theory will suffer the same fate as the MMR theory.

The number of people applying to the “vaccine court” for compensation for autism peaked six years ago. 2,437 families petitioned the Court for hearings alleging autism as a vaccine injury in 2003. In 2008 that number shrank to 253. The vaccines-cause-autism theory is clearly losing ground even within the autism community.

That doesn’t mean that the vaccines-cause-autism organizations are giving up. Quite the opposite. They are ratcheting up the pressure, focusing on individuals.

I actually find it hard to consider the vaccine/autism groups to be separate entities. These groups are SafeMinds, Talk About Curing Autism (TACA), the Autism Research Institute (ARI), Generation Rescue, and The National Autism Association (NAA). They do vary in their approaches to some topics. For example, TACA and Generation Rescue put more resources into direct contact with families than, say, SafeMinds. But, when it comes to lobbying about vaccines, they are pretty much a single organization, sharing a significant amount of key personnel.

These organizations are represented on the IACC by Lyn Redwood of SafeMinds. The grassroots activist efforts of the organizations is coordinated through their blog, the Age of Autism. It is a particularly clever and effective construct: the advocacy organizations can claim to be separate from the particularly nasty rhetoric of their own blog. As a separate entity, the finances of the Age of Autism blog will not be made public.

That all said, the Age of Autism should be considered the voice of these organizations and the actions coordinated on that blog are the actions of its parent organizations.

I can understand why groups such as SafeMinds or Generation Rescue would want to be able to claim some distance from the Age of Autism (AoA). AoA is used to coordinate serious intimidation efforts.

The recent departure of Dr. Story Landis from the IACC was engineered by AoA. They found notes made during an IACC meeting and planned a surprise attack to coincide with an IACC meeting. As an ironic twist, AoA got someone sympathetic to their cause to resign the IACC.

AoA has also targeted IACC member Yvette M. Janvier, M.D., twisting her words “the idea that autistic kids are sick offends me!” into “I am offended by sick autistic kids”.

AoA launched an attack on IACC coordinator Joyce Chung. This coincided with a week long IACC meeting to iron out the Strategic Plan. Her “crime”? She is married to Richard Grinker, author of Unstrange Minds. Dr. Grinker is public in his belief that there has not been an epidemic of vaccine-induced autism, a belief held by the vast majority of the autism research community. What does Dr. Chung have to say publicly on the subject? Nothing as far as I can see. What actions did she take that warranted an attack? None.

The good people at AoA have attempted legal intimidation as well. They got a Congressional Oversight Committee to investigate the IACC. When that didn’t pan out, they sought “legal advice” on alleged FACA violations. No word on what, if anything, became of that effort either. The Age of Autism isn’t shy about touting their attacks. It would seem safe to assume this one failed.

AoA has recently set their sights on the IACC’s chair, Dr. Tom Insel. I am sure this came as no surprise to Dr. Insel. Earlier this year he called for a re-vote on a proposal to add a vaccine study to the IACC’s Strategic Plan, and later made public statements in a congressional hearing that there wasn’t enough data to warrant a vaccine-autism study.

Other than being bold enough to discuss the view held by the vast majority of autism researchers, what is Dr. Insel’s greatest crime? His brother invented a vaccine. Yes, Dr. Richard Insel helped develop a vaccine for Haemophilus influenza B (Hib). This vaccine has been quite effective in reducing Hib infections. But, any contact with vaccine research or company is considered a fatal conflict of interest to the bloggers at the Age of Autism.

I’m sure that there is more going on behind the scenes.

If this were all to the story, it would be sad but uninteresting. Unfortunately, there is fallout from all of this intimidation. I already know that good researchers have avoided autism as a subject in order to avoid the groups represented by the Age of Autism. I suspect that good people are avoiding participating in the IACC meetings as well. But, the most direct fallout is that the IACC members are unable to speak their minds on the subject of vaccines. Beyond vaccines, they have to live in fear of any possible infraction of the rules or any statement that could be misinterpreted will be used against them. A prime example was given above where “the idea that autistic kids are sick offends me!” was warped into “I am offended by sick autistic kids”.

If this were some minor, make-work bureaucratic committee with no real impact I wouldn’t care. But this is the group that sets the plan for the largest autism research in the world. Not only is this sort of intimidation a crime in general, it is hurting my kid’s chances at a better life.

It is time for the intimidation to stop. The Age of Autism bloggers should learn a lesson from their recent, childish attack. Acting out without thinking can hurt even them. This event is being noticed. Both the journals Nature and Science have blog posts about this recent debacle. The Simons Foundation interviewed the director of the NIH on the subject.

I’ll say it again: it is time for the intimidation to stop.

The problem with the IACC is…

27 Apr

…that Tom Insel is too nice.

OK, that is as oversimplification, but bear with me. Dr. Insel is the director of the NIMH (National Institutes of Mental Health) and the chair of the IACC (Interagency Autism Coordinating Committee). As chair, he gets to run the meetings. Lucky him!

I say that with tongue planted firmly in cheek. Dr. Insel has a tough job trying to manage the IACC.

Let’s back up a little bit. The IACC committee meets regularly to work on producing a plan for the government’s research effort in autism. The idea is simple–gather together a lot of people who can bring their expertise to the table and work together to build a good plan.

Unfortunately, Lyn Redwood apparently didn’t get that memo. Ms. Redwood represents her organization (Safe Minds) as well as the views of a number of other autism organizations who promote the idea that vaccines caused an epidemic of autism.

Lyn Redwood spends each meeting as though it is held for everyone to listen to her talk about vaccines. I know that sounds like an exaggeration–it isn’t. Here is a quote from another member of the IACC committee from a recent meeting, speaking about an effort by Lyn Redwood to insert a large amount of new language into the Strategic Plan.

I’m just a little perplexed as to why we are actually looking at this. Because we worked so hard over many months as a committee and..you know..and as one person in the field who is constantly seeing more and more children with autism this sense of urgency seems to sabotaged by this constant barrage of another opportunity for one person of this committee to constantly try to rewrite the Plan. It doesn’t seem to be the correct process.

Dr. Insel then commented “There are heads shaking here.” “Heads Shaking” is what Dr. Insel says when people are nodding in agreement during a meeting. In other words–a large portion of the IACC agreed with the idea that Lyn Redwood was hijacking the process again!

The problem is, to say it again, Tom Insel is too nice. He gives Lyn Redwood a LOT of leeway to talk about…well, whatever she wants to talk about. Unfortunately, she spends a lot of time talking vaccines. Lots of time. The IACC doesn’t have lot’s of time to spend on any one subject. Especially a subject like vaccines that the rest of the committee clearly isn’t interested in discussing. To make matters worse, many of the discussions are nearly meaningless. “Should we phrase this noncommittal statement this way or that way?”

Another person draining a lot of valuable time from the IACC is Mark Blaxill. Mr. Blaxill is not on the main IACC committee. He is in one of the working groups (think advisory group to the main committee). While, luckily, he doesn’t get to vote in the main committee, in his own way he is worse than Ms. Redwood. He makes long speeches, filled with insults to the other committee members, calling those who don’t agree with him “Epidemic Denialists”.

It strikes this listener that Ms. Redwood and Mr. Blaxill are trying desperately to engage the other IACC people in a debate on the autism vaccine question. Ms. Redwood has offered to bring in papers supporting her position. Thankfully, Dr. Insel avoided that mess. I can easily imagine many of the researchers on the IACC thinking, “Gad! I already wasted part of my life on that junk science when I read it the first time. Can’t we just get something accomplished for people with autism here?” I mean, seriously, does Ms. Redwood think that people haven’t read the papers she leans on? The implications sounds like, “You don’t agree with me. That means you haven’t read these studies.” What she doesn’t understand is that pretty much everyone has read the studies she uses as support for the “mercury and vaccines caused an autism epimic” idea. Everyone has read them, and most who have read them find them to be really bad science. The academics could use them as examples of bad science for their students. Those studies are that bad.

Here’s some much needed background. The IACC committee is made up of a number of professionals and stakeholders. People fly in from all over the US to attend meetings–most of which are only a day long. The agendas are packed; there isn’t much time to waste.

Rather than accept that IACC meeting time is limited and precious, with many topics to cover, both Ms. Redwood and Mr. Blaxill act as though they are in one of Senator Dan Burton’s hearings, where the goal was to get as much of the idea that vaccines cause autism into the public record as possible–whether the science was good or not.

So, what’s happening while Ms. Redwood or Mr. Blaxill are talking? This is where the “Tom Insel is too nice” bit comes into play. Dr. Insel, chair of the IACC, allows them all the time they want to take (and they want a lot of time) to talk about vaccines. I don’t know how much of it is Dr. Insel being polite or how much is an effort to stave off future complaints that the vaccine lobby was excluded from the process. There are likely multiple reasons. Net result–lots of time taken up talking about vaccines.

Well, that’s not really accurate. There is a lot of time lecturing about the supposed vaccine/autism link. You see, there is almost no discussion amongst the commitee. Just the one-sided presentations by Lyn Redwood and Mark Blaxill. The rest of the IACC members often (almost always) remain silent. My guess is that they are just too smart to get dragged into the discussions. Yes, too smart. What purpose would it serve?

From what I can see, the rest of the IACC “gets it”. They “get it” in the fact that they already understand the vaccine debate. I don’t see the point in taking up committee and working group time with Lyn Redwood or Mark Blaxill pretending to be trying to educate the other members. The rest of the IACC also “gets it” in the fact that they understand to avoid getting sucked into the debate. Mark Blaxill would likely enjoy some blog fodder. The likes of David Kirby and Robert Kennedy Jr. would love to take everything out of context and misinterpret it for their own blog readers. All this would come at the cost of people with autism.

Dr. Insel could, I guess, limit the time that Ms. Redwood and Mr. Blaxill use. To be honest, he does manage their time somewhat, but much more would help keep the meetings productive. Dr. Insel is in a hard spot–even a reasonable level of limiting the discussion would obviously be used to fuel complaints that the vaccine debate is being quashed or the process is corrupt.

So, in the end, Dr. Insel plays the nice guy. What else can he do? Lyn Redwood and Mark Blaxill take advantage of it and, in the end, it is people with autism who pay the price when the IACC meetings are hijacked and the sense of urgency is lost as one person tries to rewrite the strategic plan.

The vaccine-autism org spin on the IACC

2 Feb

The vaccine-oriented autism orgs are claiming that the IACC acted improperly when they removed the vaccine initiatives from the Strategic Plan. They claim that this wasn’t on the agenda. Uh, yeah.

Let’s take a second look at this, eh? Because, from what I can see, not only is there a lot of spin being added to this story, the spin is filled with hypocrisy.

These vaccine initiatives were added at the December IACC meeting. Here’s the agenda for that meeting. I don’t see where it says, “Add new initiatives”.  And, yet, here they are in the draft of the Plan.  Note that the vaccine initiatives are in all red–they were added at that meeting.

That’s not “according to procedure”, if we take the SafeMinds/TACA/GR/NAA spin where it has to be clearly in the agenda.

It isn’t even “according to procedure” in the real sense.  Science based initiatives are supposed to be generated by subcommittees who vet them based on need and whether they have a reasonable scientific basis.

Or, to put it another way–vaccines were added to the Plan at the last minute as part of an end-run around the system by Lyn Redwood. And, now, she and the vaccine-orgs are complaining that the removal of these initiatives is part of a “improper action” or some such nonsense because it wasn’t in the agenda.

Not merely a weak argument, but hypocritical as well.

Let’s take a look at some similar actions.  The January IACC meeting included an attempt by Lyn Redwood to basically rewrite the introduction to the Plan. (By the way, one of the IACC members called Lyn Redwood out (politely) on her constant attempts to rewrite the Plan, noting how this has delayed the entire process considerably. Thank you, whoever you are.)

Let’s take a look at the agenda for the January meeting. Do you see any mention of rewriting the introduction in there? I don’t. So, what do we have here? We have Lyn Redwood attempting to circumvent the procedure and introduce new initiatives outside of the process. Then, when they are removed, she cries foul, claiming that others are working outside of the process?!?

Clearly, this is a political move.  Adding vaccines to the Plan was a political move, not a scientific move.   The complaints lodged against the removal of the vaccine initiatives are political, not reality based.

And, while all this plays out, good research is stalled.

That’s a complete shame.

← Older Entries
Newer Entries →