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Tuesday, December 31, 2013

Five Most Effective Parenting Programs to Reduce Problem Behaviors in Teens

From ScienceDaily.com

December 16, 2013

"All of us need a little help parenting. It's a tough job, and we didn't get the instruction manual when our kids were born."

All parents want what's best for their children. But not every parent knows how to provide their child with the tools to be successful, or how to help them avoid the biggest adolescent behavior problems: substance use, delinquency, school dropout, pregnancy and violence.

These problems can affect children for the rest of their lives. University of Washington researchers evaluated about 20 parenting programs and found five that are especially effective at helping parents and children at all risk levels avoid adolescent behavior problems that affect not only individuals, but entire communities.

"With these programs, you see marked decreases in drug use, reduced aggression, reduced depression and anxiety, and better mental health," said Kevin Haggerty, assistant director of the UW's Social Development Research Group in the School of Social Work.

"You see the impact of when parents get on the same page and work together to provide an environment that promotes wellbeing. You can make long-term impacts."

The study is published in the current issue of the Journal of Children's Services.

Haggerty said it's ironic that parents spend hours taking birthing classes to prepare for something that will happen naturally, yet there is no training on how to actually parent a child. He took a parenting workshop years ago and said learning how to deal with conflict changed his family's dynamic.

"All of us need a little help parenting," Haggerty said. "It's a tough job and we didn't get the instruction manual when our kids were born."

The programs recommended by Haggerty and his co-authors are effective with a wide variety of families in diverse settings. All five programs are consistent with the Social Development Model, which focuses on fostering opportunities, skills, rewards for positive social behaviors, bonding and clear expectations for behavior.

The programs include changing known risk factors such as poor parental supervision and high family conflict, and show children what "normal" family behavior looks like. The programs also have scientific evidence showing that they work.

Nurse-Family Partnership sends registered nurses to visit young, first-time, single mothers at least once every two weeks during their first pregnancy and until their child is 2 years old. Nurses help expecting moms reduce smoking, drinking and drug use. After the child is born, nurses help mothers create safe environments for their children and develop strategies for dealing with difficult behaviors.

Positive Parenting Program is a flexible system of programs that focuses on five main goals: promoting safe and engaging environments, creating positive learning environments, using effective discipline, creating clear and reasonable expectations, and self-care for parents.

The Incredible Years teaches children ages 3-6, their parents and teachers skills and strategies for handling difficult situations. Parents participate in group sessions; children take part in therapist-led group sessions, which help children develop skills such as problem solving, making friends, and cooperating with others. (This program was developed by Carolyn Webster-Stratton, now director of UW's Parenting Research Clinic.)

In Strengthening Families Program: For Parents and Youth 10-14, parents learn about risk factors for substance use, parent-child bonding, consequences for not following parental guidelines, manage anger and family conflict their children learn effective communication, problem solving, and how to resist peer pressure.

Staying Connected with Your Teen helps children 12-17 years old avoid risky sexual activity, drug use, and violent behavior. The program helps parents set strong norms with their teen against antisocial behavior by increasing parental monitoring, reducing harsh parenting, and rewarding teens to promote family bonding. (This program was developed by Richard F. Catalano and J. David Hawkins in the U.W. School of Social Work.)

Haggerty and his fellow researchers hope local policymakers will pay attention to these and other scientifically-tested programs as they discuss investments in child and adolescent resources. He said it's important to invest in children now, before negative outcomes cost society more in the form of law enforcement, prisons, and physical and mental treatment programs.

Journal Reference


Kevin P. Haggerty et al. Promising parenting programmes for reducing adolescent problem behaviours. Journal of Children's Services, 2013 DOI: 10.1108/JCS-04-2013-0016

Book Review - Girls Under the Umbrella of Autism Spectrum Disorders: Practical Solutions for Addressing Everyday Challenges


From Autism Daily Newscast

December 21, 2013

Girls Under the Umbrella of Autism Spectrum Disorders

Author: Lori Ernsperger, Ph.D. and Danielle Wendel
Publisher: Autism Asperger Publishing Company (2007)
ISBN: 978-1-931282-47-5

Even the cover of this book takes on a personal and inspiring touch. It features a beautiful painting done by 11-year-old Amanda LaMunyon, who falls under the autism spectrum. A poem and story by this talented young girl are also part of the book.

The first-hand, up-close-and-personal approach to the condition is what helps make the book special. The writing duo behind the project is Lori Ernsperger, a Ph.D. and expert in autism and behavioral disorders, and Danielle Wendel, co-founder of The Asperger’s Syndrome High-Functioning Autism Support Group, and most importantly, mother of an 11-year-old girl named Mattie, who lives under the autism spectrum umbrella.

The result is that there is all the research and fact-based material you could ask for, easily and helpfully explained, plus the hands-on, personal revelations of a mother who has “been there.”

The book gives a general overview of the spectrum including signs to look for in determining if your daughter has autism, Asperger’s, Pervasive Developmental Disabilities or any other condition that falls under the umbrella. It addresses the feeling of officially getting the diagnosis and dealing with it, coping with the early years, proper schooling, handling bullying, adolescence and early adulthood, dealing with temper tantrums, managing sleep issues, and how to approach the future (dating, marriage, and having a family).

Techniques for dealing with certain behaviors specific to those under the autism spectrum should prove very effective for parents or teachers. At all times, the emphasis is on what sets girls apart from boys in terms of the condition because sadly, until recently the medical community either saw autism and its related conditions as affecting more boys than girls, or not making a difference whether a boy or girl was affected by it. Girls therefore, were not treated or diagnosed based on any specific qualities or problems they presented.

While there is a good deal of clinical or professional information presented in the book, its most special quality is the way parents and girls or women who are actually living with an autism-related condition have come forward to share their most intimate thoughts and experiences. At times, it reads like a journal of personal recollections and secrets that are being shared for the first time.

The emphasis is definitely on those who function on a fairly high level in the “real” world, so those looking for help with the fairly small group of girls who do not speak, interact or live much of a full life may be slightly disappointed. Still, there is bound to be information here to satisfy most parents, teachers, and most importantly, those special girls who are “under the umbrella.”

Monday, December 30, 2013

Cognition and Behavior: Sticky Gaze May Be Early Autism Sign

From SFARI.org
The Simons Foundation Autism Research Intitiative

By Jessica Wright
December 20, 2013

Babies later diagnosed with autism tend to stare at objects after picking them up at much later ages than controls do, according to a study published in Behavioral Brain Research (1).

This delay may contribute to problems with joint attention — the tendency to seek out and follow others’ gaze — in autism, the researchers say.

Babies who pick up an object continue to look at it for about a second afterwards, a behavior researchers call ‘sticky attention.’ At 1 year of age, however, they tend to look away as they touch the object, or immediately before. This may allow them to switch their focus to another object or person in the room.

Make believe: To encourage children to grasp

objects, researchers make a birthday cake out of
Play-Doh and tell the children that a baby doll is hungry.
Studies have shown that babies later diagnosed with autism still show sticky attention at about 12 months of age (2). The new study follows the development of sticky attention over time in babies at risk for autism and controls.

The researchers looked at 10 typical babies and 20 baby siblings of children with autism, half of whom were later diagnosed with the disorder. They observed the children every three months from 6 to 18 months of age, and then again at 24 and 36 months of age. They evaluated the children for autism diagnoses at 36 months, using the Autism Diagnostic Observation Schedule and the Autism Diagnostic Interview-Revised, two well-established diagnostic tests.

Children with autism and controls both show sticky attention at 6 months of age. In controls, this drops from 80 percent of the time at 6 months to about 22 percent at 12 months and not at all by 24 months of age.

In contrast, toddlers who develop autism show sticky attention well past 12 months of age: 58 percent of the time at 12 months and 36 percent of the time at 24 months of age. By 36 months, however, they switch their focus almost as often as typically developing children do.

This may be because by this age, children tend to pick up the objects with more practical intention, the researchers say. They are also more accustomed to the objects, and so may be less caught up in the sensations they evoke.

The findings provide an early indicator of autism seen before the age of diagnosis. They also suggest a difference in attention that may get in the way of social interactions during a crucial developmental time period, the researchers suggest.

References

1: Sacrey L.A. et al. Behav. Brain Res. 256, 441-450 (2013) PubMed

2: Elsabbagh M. et al. Biol. Psychiatry 74, 189-194 (2013) PubMed

Failings in Mental Health Care for Adults With Autism

From HuffPost Healthy Living

By Neil S. Greenspan
December 12, 2013

This past September, in a New York Times op-ed, the eminent neuroscientist Eric Kandel expressed his optimistic views, based on recent research advances, regarding the future of psychiatry. The scientific progress envisioned by Dr. Kandel may help to improve therapy and ameliorate some of the deficiencies in psychiatric diagnosis, which currently rest primarily on observed behaviors and not on underlying cellular or molecular meachanisms -- a situation not really improved by the widely discussed, and widely criticized, fifth edition of the Diagnostic and Statistical Mannual (DSM-5) of the American Psychiatric Association released earlier this year.

Even advances of the scope predicted by Dr. Kandel are not likely to eliminate other fundamental problems afflicting psychiatry and clinical psychology as they are now actually practiced by mainstream professionals. Patients with autism are one group for whom the deficiencies in current psychiatric and psychological treatment are particularly evident.

One key problem repeatedly encountered with both psychiatrists and psychologists is the failure to adequately monitor clinical progress of patients with autism according to any objective standard. Often intertwined with this deficiency is the unwillingness to think critically about possible alternative approaches or, in the absence of significant improvement, to consider referral to other practitioners with more or different expertise.


Too frequently, only approaches that are convenient and routine for the practitioner are or employed or even considered.

In one instance, I directly asked a doctor if she knew of anyone, even someone in another city, who might know of potentially more successful treatment methods. The doctor's response was reducible to the word, "No." In retrospect, this response suggests either that this well-regarded physician had inadequate knowledge of her field, or that she was being disingenuous.

Many professionals representing themselves as competent to treat autism are in fact unqualified to do so, their formal credentials notwithstanding. Such practitioners are cryptic charlatans. While they may use "accepted" approaches, they provide care that, like therapies offered by classical quacks, has minimal probability of providing significant benefit.


(Non-standard treatments for autism, many of which are highly problematic and sometimes even dangerous, require separate discussion.)

For example, anyone with insight into autism would recognize that seeing some patients once a week or every other week for one hour or less is not a plausible avenue to effective therapy when the goal includes significant behavioral change. In addition, for certain patients the reliance on conversation alone, despite the well-known limitations of this treatment modality in the context of autism, wastes time, effort, and financial resources that could be better directed elsewhere.


Individuals who think in very concrete terms and have limited ability to grasp abstract concepts generally lack the sort of self-insight necessary to modify their behaviors merely from discussing past or future scenarios with a therapist.

Pharmacological therapy is based almost entirely on a highly inefficient and sometimes costly trial-and-error approach and may be influenced by pressure from pharmaceutical sales representatives. Furthermore, psychiatrists or their equivalents pay insufficient attention to drug-associated side effects. 
Concern is especially lacking for drug-associated symptoms regarded by practitioners as relatively minor because they are not directly life threatening or do not necessitate hospitalization.

Even side effects regarded as clinically insignificant by professionals, such as alterations in temperature regulation, induction of mild dizziness, increased anxiety or intensified aggression can have major consequences for patients and their relatives in terms of family dynamics, risk of physical injury, or tremendously damaging entanglements with the legal system that engender complications and further crises in a viciously negative positive feedback loop.

To take one of many possible examples, a physician prescribed aripiprazole (marketed as Abilify) for a young adult patient I know. Almost immediately after beginning therapy, the patient complained of severe and incapacitating leg pain. At the insistence of the patient's parents, the drug was discontinued. Some months later the physician thought it appropriate to again try aripiprazole. As before, severe leg pain occurred.

The patient's sibling found a case report online that described an extremely similar scenario. Again the parents insisted that the aripiprazole be discontinued, sent the case report to the physician, and emphasized the likelihood that the leg pain was a side effect of aripiprazole. Although the physician discontinued the medication, he did not appear to be convinced by the evidence presented that aripiprazole was the cause of the leg pain. Two other young adults in the same locale with similar diagnoses and behavior profiles also experienced similar undesirable symptoms associated with taking arpiprazole.

Beyond the problems with outpatient care, most hospital emergency departments and in-patient psychiatric wards are poorly suited to help patients with autism in any substantial or long-term sense. Transporting agitated individuals to emergency rooms typically generates medical bills in the thousands of dollars without providing substantial or lasting benefit to the patients or their families, and sometimes such encounters make matters worse. Some police departments automatically transport agitated individuals to hospital emergency rooms without recognizing the profound limitations of these facilities or of their own policies.

Unfortunately, many of the governmental, legal, and social systems that interact those affected by autism base their policies and practices on the false notion that most professionals and hospitals are competent to provide care for these individuals. It is long past time to acknowledge that the evidence routinely contradicts this assumption.

Finally, if leaders of the organizations representing psychiatrists or psychologists respond by assertinging that "most practitioners" are competent and professional and do not exhibit the deficiencies I have claimed, it is fair to note that such claims will likely lack any substantiation.


In any case, the wishful thinking of such spokesmen does not trump direct observations by parents and other caretakers of individuals with autism. While my criticisms presumably do not apply to all practitioners or necessarily to the treatment of individuals with other conditions (although some applicability seems likely from what others have reported), I emphatically reject the rotten fruit theory, e.g., the notion that the problems highlighted above are rare and due to the failings of a few "bad apples."

While there are professionals who can help individuals with autism, they are probably in the minority, and the problems with care delineated here are both pervasive and consequential.

......................................................................

Neil Greenspan is an immunologist and clinical pathologist in Cleveland and a member of the board of directors of the Think Computer Foundation, which supports social and recreational activities for adolescents and adults with developmental disabilities.

Sunday, December 29, 2013

Autistic Women: Misdiagnosis and the Importance of Getting it Right

From the Autism Women's Network

By Cynthia Kim
December 16, 2013

If you're autistic, there's a good chance you have also been given at least one of the following diagnoses: generalized anxiety disorder (GAD), social anxiety disorder (SAD), ADD/ADHD, obsessive-compulsive disorder (OCD), eating disorder, major depressive disorder (MDD), Tourette's Syndrome, bipolar disorder or borderline personality disorder (BPD).


Current research suggests that as many as 8 out of 10 autistic individuals have at least one other psychiatric condition--commonly referred to as a comorbid condition.

Are autistic people predisposed to certain psychiatric conditions or are our autistic traits commonly mistaken for symptoms of other conditions?


As someone who received a dual diagnosis of anxiety disorder and Asperger's Syndrome, I've spent a lot of time thinking about how my anxiety relates to being autistic and whether it is, in fact, disordered.

In talking to other women about their experiences with the mental health system, I discovered that this is a common reaction to a comorbid diagnosis. While most women on the spectrum feel that their autism diagnosis is a good fit, our relationship with our other mental health labels varies greatly.

Nattily, who received her autism diagnosis at age 25, was diagnosed with several other conditions in high school and college:

"I was diagnosed with major depression as a teenager when someone told the school I had been self-injuring for a couple years."

She believes that was a misdiagnosis, and says that the mishandled intervention that followed made her skeptical of getting help for other conditions:

"Later, in college, I was diagnosed with anorexia and... bipolar disorder. I disagreed... at first, but I think that's pretty common. I see now, about six years later, that they are both accurate and that they both require treatment," she said, adding that the treatment she's received for both has been on target and helpful.

For other autistic adults, depression and anxiety are seen as side effects of being autistic in a neurotypical world. Carolyn, who in addition to identifying as autistic has been diagnosed with GAD and MDD, says:

"I've had symptoms of both since about middle school, and those I feel are related to my neuroatypicality, or at least to my navigating of the world while neuroatypical."

She goes on to wonder if those symptoms would exist or would be as severe if she wasn't on the spectrum.

Some professionals have taken the relationship between anxiety, depression and autism a step further. Bartak, Bottroff and Zeitz have proposed a model that suggests anxiety and depression, especially in autistic adults, often result from "ineffectual intervention strategies" used by professionals who fail "to recognize the developmental features and dynamic and functional aspects" of autistic behavior.

In other words, [1] being autistic doesn't necessarily raise our chances of having anxiety or depression. A more likely risk factor is the use of intervention strategies that don't take into account the functional aspects of autistic behavior.

Many of the women I talked to for this article agreed that the anxiety or depression diagnoses they'd been given were accurate, but added that those diagnoses alone didn't tell the whole story. And that's where comorbid conditions can present a problem for autistic adults.

Misdiagnosis: When Comorbids Take Center Stage

Finally diagnosed at 44 with ASD, Jayne says that during the year and a half it took to make herself understood to mental health professionals:

"...a lot of other mental health conditions were put forward. My communication is bad and I was suffering from posttraumatic stress and I had to keep saying, 'No that's not right' until someone mentioned autism and I looked into it and said, 'That's it.' It was a relief."

Like many late-diagnosed women, she invested a significant amount of energy in advocating for herself as she sought an explanation that fit.

Viewing autism through the lens of a single strong or dominant trait can lead to misdiagnosis. For example, an adult with strong perservative tendencies may be incorrectly diagnosed with OCD. Serious difficulties with executive function can mimic the symptoms of attention disorders (ADD/ADHD). Some adults go through life accumulating an alphabet soup of diagnoses: ADHD, OCD, GAD, SAD, BPD . . . when, in fact, a single correct autism diagnosis would better account for most of their symptoms.

If a clinician views a comorbid disorder as the primary reason that a patient is seeking help, they might simply stop there, missing other symptoms of autism. Women in particular may be vulnerable to misdiagnosis because autism is assumed to be less common in females. When a clinician subscribes to the myth that autism is an unlikely explanation for a female patient's difficulties, he or she may reflexively look to other conditions first for a more likely answer.

A woman who reports feeling sad and lifeless due to autism-related difficulties with maintaining relationships may be diagnosed with major depression. The same is true of a person who rarely leaves the house, has few social supports, or lacks interest in social activities. Clinicians can look at these atypical behaviors and see them as signs of depression rather than autistic traits.

While treatment for depression may be warranted, treating an autistic person only for depression without also providing help for building coping skills will likely result in frustration for both the patient and the clinician.

The same is true of anxiety disorders, especially social anxiety disorder or social phobia, which are commonly diagnosed in autistic women, either alongside or in place of autism. Some clinicians fail to differentiate between the irrational social anxiety that fits the definition of a separate disorder and the rational fear of social interaction that occurs when a person struggles to read body language, make small talk or follow a conversation in a noisy room.

As Emily puts it:

"While I do have social anxiety, I do not have the disorder. If every time you try to do something, you mess it up, you start to get pretty frustrated and you might want to give up. But I can't give up on social interaction - you have to interact competently with people to be an adult in our society. So stakes are pretty high on me pulling it off, but I'm very bad at it. The combination of high stakes on something I'm very bad at is what causes my anxiety - just like someone who's bad at math but needs to pass their exam to get into a program or job they want would get anxious over that exam. Except my exams are all day, every day."

The distinction between justifiable social anxiety and a social anxiety disorder is important. For many autistic adults, it may be the difference between the road to self-acceptance and reasonable accommodations or years of self-defeating therapy to fix a disorder that doesn't exist.

The Importance of Accurate Diagnosis

Inaccurate diagnosis can have life-altering consequences. Helena, who was diagnosed with BPD as a young woman, spent a year and a half in the youth ward of a psychiatric hospital. She described many aspects of her care as helpful, particularly the highly structured nature of the program, the emphasis on daily physical exercise and the many opportunities for social interaction. However, she also sees the lost opportunity in her misdiagnosis:

"I think they were misinterpreting everything I did and assigned me motivations I didn't have . . . Possibly that partly explains why the treatment was quite ineffective and why I stayed so long and they didn't know what to do with me."

Bartak and his colleagues believe that this type of diagnostic confusion sets the stage for misdiagnosis, particularly in autistic individuals with comorbid psychiatric syndromes.

After being diagnosed with autism in her early forties, Helena now believes that what her doctors described as "BPD emotional instability" was actually autistic meltdowns due to social stress and the stress of living in an institutional setting. With a more accurate assessment perhaps her treatment would have been more effective, shortening her time spent in care.

"The problem solving focus was not on the right areas," she says. "What the focus should have been: help to develop independent living skills / executive function skills and social skills, because those were my core problems."

[1] p. 249-250 in "Stress and Coping in Autism"

About the Author

Cynthia Kim is the proud owner of many labels including woman, wife, mother, writer, editor, entrepreneur and most recently, autistic. Diagnosed with Asperger's in her early forties, she began blogging about life on the spectrum at Musings of an Aspie. She is the author of "I Think I Might Be Autistic: A Guide to Autism Spectrum Disorder Diagnosis and Self-Discovery for Adults," and is a regular contributor to Autism Parenting Magazine. When she's not writing about all things autism, she indulges her passion for words by running a small publishing company and occasionally dabbling in fiction, which sometimes gets published.

Saturday, December 28, 2013

Autism and Gastrointestinal Problems Linked?

From the U.C. Davis MIND Institute

December 16, 2013

"Our data clearly show that gastrointestinal problems are very common in children with autism."

Children with autism experience gastrointestinal (GI) upsets such as constipation, diarrhea and sensitivity to foods six-to-eight times more often than do children who are developing typically, and those symptoms are related to behavioral problems, including social withdrawal, irritability and repetitive behaviors, a new study by researchers at the U.C. Davis MIND Institute has found.

The researchers said that understanding the impact of GI problems in children with autism could provide new insight into more effective and appropriate autism treatments that could decrease their GI difficulties and that may have the potential to decrease their problem behaviors as well.

The investigation is the largest and the most ethnically diverse study comparing GI problems in children with autism, developmental delay and typical development, and among the first to examine the relationship between GI symptoms and problem behaviors in children with autism, the researchers said.

"Gastrointestinal Problems in Children with Autism, Developmental Delays or Typical Development" was published online today in the Journal of Autism and Developmental Disorders.

"Parents of children with autism have long said that their kids endure more GI problems, but little has been known about the true prevalence of these complications or their underlying causes," said Virginia Chaidez, the lead study author who was a postdoctoral student in the U.C. Davis Department of Public Health Sciences at the time of the study.

"The GI problems they experience may be bidirectional," Chaidez said. "GI problems may create behavior problems, and those behavior problems may create or exacerbate GI problems. One way to try to tease this out would be to begin investigating the effects of various treatments and their effects on both GI symptoms and problem behaviors."

The study was conducted in nearly 1,000 children enrolled in the Childhood Autism Risks from Genetics and the Environment (CHARGE) Study in Northern California between April, 2003 and May, 2011. The children were between 24 and 60 months at the time when they were enrolled in the study. Their diagnoses were confirmed through assessments at the MIND Institute.


Roughly half of the study population was white and one-third was Hispanic. The remaining participants were of other ethnic and racial backgrounds.

The study was conducted by asking the children's parents to complete two self-administered questionnaires, the CHARGE Gastrointestinal History Questionnaire (GIH) and the Aberrant Behavior Checklist (ABC).


The GIH measures such disorders as abdominal pain, diarrhea, constipation and difficulty swallowing. The ABC measures challenging behaviors including irritability, lethargy/social withdrawal, repetitive behaviors (stereotypies), hyperactivity and inappropriate speech.

The researchers found that the parents of children with autism were six-to-eight times more likely to report frequent gaseousness/bloating, constipation, diarrhea and sensitivity to foods than were the parents of typically developing children. Similarly, parents of children with developmental delay were five times more likely to report constipation and far more likely to report difficulty swallowing.

"After years of parents raising concerns about such symptoms, the huge differences we see between parental reports on children with autism spectrum disorder versus those on children with typical development puts to rest the idea that gastrointestinal problems among children with autism spectrum disorder are just an accumulation of case reports," said Irva Hertz-Picciotto, principal investigator for the CHARGE Study and a researcher affiliated with the MIND Institute."

"Our data clearly show that gastrointestinal problems are very common in children with autism."

Among parents of children with autism, those who reported their child had abdominal pain, gaseousness/bloating, constipation and diarrhea also significantly more frequently noted irritability, social withdrawal, repetitive behavior and hyperactivity than did those without GI symptoms. The only behavior problem that was associated with a GI problem in children with developmental delay was hyperactivity and only among those children with diarrhea.

The researchers said that the study suggests that a chronic GI symptom, which can cause pain, discomfort and anxiety, could contribute to increased irritability and social withdrawal, particularly in children with deficits in social and communication skills. For children with autism, hyperactivity and repetitive behaviors may represent coping mechanisms for physical discomfort.

In children with autism who have problem behaviors a full GI evaluation could be beneficial, especially in children who are non-verbal. For this population, appropriate medical treatment may alleviate undiagnosed GI problems, and it is possible that there also could be some improvement in problem behaviors, the researchers said.

The researchers did not address the reasons why the children with autism and developmental delay experienced more GI difficulties in this study. They noted that their findings suggest that the subject warrants additional inquiry.


...........................................................................

The study was funded by National Institute of Environmental Health Sciences (grants P01 ES11269 and R01 ES015359-03S2); U.S. Environmental Protection Agency (grants R833292 and R829388); Autism Speaks (grant 7567); and a grant from the U.C. Davis MIND Institute.

Demystifying Vaccine Ingredients - Formaldehyde

From Harpocrates Speaks

April 5, 2012

There seems to be a lot of fear and confusion surrounding many of the ingredients (PDF) that are listed as being in vaccines. Many of them have long, scary or hard to pronounce chemical names, like polyethylene glycol. Others just sound a little disturbing, like chick embryo fibroblasts. Then you have more familiar chemical names that have some manner of negative connotation associated with them, such as formaldehyde.

Generally, in discussions about such ingredients, those who are in some manner opposed to vaccines will say something about "the toxins!" What they actually mean is generally unclear.

Just as unclear, at times, is what the supposed toxin is supposed to do; how is it supposed to hurt people? They may not be certain what it does or why it is bad, but they know it is bad and that's that. I thought I might turn my hand, then, toward trying to understand, from a lay perspective, what these ingredients are, how they are used and whether they really are, as claimed, "toxic". Let's start with formaldehyde.

What is Formaldehyde?

Formaldehyde is a colorless gas with a rather strong odor, made up of a carbon atom, two hydrogen atoms and an atom of oxygen, CH2O. It has very potent antibacterial and antifungal properties. Many textile industries use formaldehyde in their production processes. It is used to create resins and adhesives found in products like plywood. Carpet manufacturers use it. Crease-resistant fabrics contain formaldehyde.

Facial tissues, paper towels, napkins, paints, foams, insulation all use formaldehyde. Perhaps its most famous use is in embalming, the preservation of dead tissues, at least for a short while.

With the ubiquitous manufacture and use of this chemical, questions about its safety naturally arise. OSHA has rather extensive guidelines on its safe use and health effects. Acute, short-term exposure to large amounts can be fatal. Long-term chronic exposure to inhaled or topical formaldehyde can result in respiratory illnesses, skin irritation and has long been a suspected carcinogen.

In 2011, the U.S. government changed its designation from "reasonably likely" to cause cancer in humans, based on cancer studies in animals, to "known carcinogen". However, these health issues are primarily a risk for those who regularly work with large, industrial quantities of the substance; they are exposed to much higher levels than the rest of us.

How Are We Exposed?

I won't go into industrial exposure, as it does not apply to the majority of us, but in addition to off-gassing from products like carpet, upholstery and combustibles, formaldehyde is all around us.

The NIH Report on Carcinogens (12th Edition) profile on formaldehyde states that it is in the "air, soil, food, treated and bottled drinking water, surface water and groundwater". Our primary route of exposure is breathing it, indoors or outdoors. Much of this inhaled formaldehyde comes from car exhaust, tobacco smoke, power plants, forest fires and wood stoves.

Outdoors, we are exposed to anywhere from 0 to 100 parts per billion (ppb) every day. Indoors, it can be as much as 500 to 2,000 ppb (temporary housing such as that used after hurricane Katrina measured from 3-590 ppb). To a smaller degree, we ingest it in our food and water (the average American diet contains about 10-20mg of formaldehyde from things like apples, carrots, pears, milk, etc.), as well as some exposure via cosmetics.

What many people may not know is that our own bodies produce and use formaldehyde as a part of our normal metabolism (Final Report on Carcinogens Background Document for Formaldehyde [PDF], 2010). When we are exposed to methanol (e.g., via inhalation or ingestion of foods like citric fruits and juices, vegetables or fermented beverages), our bodies break it down into formaldehyde and other byproducts.

Our bodies produce formaldehyde as a result of DNA demethylation (an important process for controlling gene expression, e.g., in developing embryos) and other biological processes. It is such a regular part of human metabolism, that our normal, naturally produced blood concentrations are generally about 2-3μg of formaldehyde per gram of blood (or about 2.12-3.18μg/mL)*. And it is actually a pretty important chemical; our bodies use formaldehyde to form DNA and amino acids (Toxicological Profile for Formaldehyde [PDF], ATSDR, 1999).

Role in Metabolism

Formaldehyde plays an essential role in our metabolism. As part of the metabolic process, formaldehyde, whether from an external source or produced by our bodies, is converted into formate (PDF) by the enzyme formaldehyde dehydrogenase. The resulting formate can then be eliminated in the urine, further broken down into CO2 and exhaled, or used by our cell machinery to synthesize nucleotides and nucleobases, such as purines and thymidine.

Purines include two of the four basic building blocks of DNA: adenine and guanine. When formaldehyde is converted into formate, the body can then use it to synthesize these basic building blocks of life.

Likewise, thymidine, also called deoxythymidine, is integral to life. It is a nucleoside, which is a class of compounds that are components of nucleic acids; in other words, you need thymidine to make the nucleic acid thymine. They also perform a lot of other important functions.

Nucleosides mediate hormone signaling and play a role in blood pressure and energy transfer, among other things (Jucker, 1993). Formaldehyde provides your body with the compounds necessary to synthesize thymidine. Just like with purines, if your body stopped using formaldehyde to make these basic compounds, well, all of your worries would disappear, since you'd be dead.

Even before the advent of industrial uses of formaldehyde, humans, as with every other animal on Earth, had been exposed to formaldehyde through the foods they ate, the environments in which they lived and their own metabolic processes. They developed the means to use the chemical for their own cellular function, as well as the ability to get rid of excess amounts that would otherwise be toxic.

How Much Is Too Much?

We know that formaldehyde is actually pretty darn important for life. We also know that too much of it can be a bad thing. But just how much is too much? When do we need to start worrying?

A good place to start is to figure out what is the NOAEL, or No Observable Adverse Effect Level. That is the largest dose at which there are no significant adverse effects among those exposed to the substance in question. Thankfully, the EPA has looked at that, and extrapolated from animal experiments what a safe level of formaldehyde exposure should be.

According to their calculations, a human could consume 0.2 mg/kg of formaldehyde every day, in addition to what their own body produces, without showing any adverse effects, such as weight loss, and that is factoring in a lot of safety buffers; the real safe exposure level is likely around 10-100 times higher than that. But, this is the EPA; they like to play it safe.

Similarly, Health Canada lists a NOAEL for indoor air concentrations of formaldehyde of 615 μg/m3, though for avoiding observable respiratory effects in children, they set the safe level for 8-hour indoor exposure at about 50 μg/m3. Again, these levels include pretty big safety buffers, with the level at which adverse effects first become apparent being much, much higher. Serious effects, like death, don't occur until even higher levels.

It has also been observed (PDF) that low-level chronic irritation and damage is reversible, that damage tends to be localized to the specific point of exposure and that it does not produce any negative effects on reproductive health or in fetuses. Carcinogenic effects appear to be only related to inhalation, affecting tissues along the respiratory pathways. But even then, there is little data in the literature showing a consistent causal relationship. Any cancerous effects, then, appear to be primarily at rather high levels of exposure.

In the end, small exposures (but still higher than average daily exposure) probably will not do you much harm beyond some irritation or minor tissue damage; it's the bigger amounts you really need to worry about.

What About Vaccines?

That brings us to vaccines. Just how much formaldehyde are we talking about? Why is it even used?

The first thing to make clear is that not every vaccine contains formaldehyde. In vaccine production, it is used to kill or inactivate the antigens being used. Because of its anti-microbial properties, it cannot be used in any of the "live" vaccines (e.g., MMR, rotavirus, varicella, and some flu vaccines), or else they would be rendered useless. Only inactivated vaccines use formaldehyde during the production process. Once the bacteria or viruses are inactivated, the formaldehyde is diluted out, leaving only minute amounts.

So how much are we talking? Not too long ago, I provided a table of all approved vaccines and their thimerosal content. I got the numbers from the package inserts, where available. It seemed to work well, so I've done the same thing for formaldehyde. Here are the formaldehyde contents of the approved vaccines (I'm only showing those that are on the recommended vaccination list):


Looking at the recommended schedule of vaccines from the CDC, let's pick the vaccines from that list that a child might receive in their first 6 years of life (picking the highest amounts, just for illustration). Note, not all of these are actually required for school entry, and lower formaldehyde content vaccines are available for most of these:

  • HepB - Recombivax - 3 doses (birth, 1-2 mos. and 6-18 mos.) - 7.5μg/dose
  • DTaP - Infanrix - 5 doses (2 mos., 4 mos., 6 mos., 15-18 mos. and 4-6 yrs.) - 100μg/dose
  • Hib - ActHIB - 3 doses (2 mos., 4 mos. and 12-15 mos.) - 0.5μg/dose
  • IPV - IPOL - 4 doses (2 mos., 4 mos., 6-18 mos. and 4-6 yrs.) - 100μg/dose
  • Influenza - Fluzone - 7 doses (6 mos., 12 mos. and yearly 2-6 yrs.) - 100μg/dose
  • HepA - Havrix - 2 doses (12 mos. and 6-18 mos. after first dose) - 100μg/dose

That's all of the vaccines on the recommended schedule for 0-6 years that contain formaldehyde. If a child got all of those doses all at once (which they never would), they would get a total of 1,824μg, or 1.824mg, of formaldehyde.

A 3.2kg (~7lb) newborn with an average blood volume of 83.3mL/kg would naturally have, at any given time, about 575-862μg of formaldehyde circulating in their blood. By the time they are 6 years old (~46lb or 21kg), they'll naturally have 3,562-5,342μg of formaldehyde in their blood.

Bear in mind that the formaldehyde from each shot will not build up in their bodies from shot to shot, as it is very rapidly (within hours) metabolized and eliminated as formate in the urine, or breathed out as CO2.

So, what's the most a child might get in a single office visit? That would probably be at their 6 month visit (when they are, on average, 16.5lbs or 7.5kg) with HepB, DTaP, IPV and flu, for a total of 307.5μg. That is about 160 times less than the total amount their body naturally produces every single day*. Compare that to the 428.4-1,516.4μg of formaldehyde in a single apple.

Now, some might try to claim that the formaldehyde in vaccines is different from the formaldehyde in your body, but they are wrong. Formaldehyde, whether it is in a vaccine or your body, consists of two hydrogen atoms and an oxygen atom bound to a carbon atom. The chemical structure is the same.

In Conclusion

Formaldehyde has a lot of scary connotations and images associated with it. It's very easy to let that fear lead us astray and blow things out of proportion. But when you step back and look at things, you realize that, where formaldehyde and vaccines are concerned, there really is nothing to be afraid of.

The amount that is present is so small as to be only a negligible exposure, one that the body very quickly handles by either using it for normal cell functions or getting rid of it completely. The beginnings of adverse effects aren't even seen until exposed to many times the residual amounts present in vaccines. While reductions in the amount of environmental exposure are a good thing, the tiny amounts in vaccines are not a health concern.

The bottom line is, put things in perspective and you'll find that what sounds scary really isn't.

Conversions

1kg = 1,000g = 1,000,000mg = 1,000,000,000μg

Here are some real-world examples of those weights (technically masses):
  • 1kg = a 1L bottle of soda
  • 1g = a paper clip
  • 1mg = a very, very small snowflake
  • 1μg = take your paper clip, cut it into a million pieces and take one of those
*With a blood half-life of about 1.5 minutes, this means that the human body produces about 50,000μg of formaldehyde every day.

Friday, December 27, 2013

Epidemiology 101: The One True (Vaccine) Study?

From Red Wine & Applesauce
Health and Science News for Moms

By Allison Hagood
December 21, 2013

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Tara Haelle: This guest post was written by Allison Hagood, who originally published a version of it on the Facebook page for Your Baby’s Best Shot, a science-based book on childhood immunizations she co-authored with Stacy Minzter Herlihy.

This post is the first in a Red Wine & Apple Sauce series called “Epidemiology 101.” While it does not explain a specific epidemiological concept, it makes clear how a mythical study often demanded by anti-vaccine propagandists would not be possible when abiding by the standards of quality epidemiological research.


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What would it take to conduct “the One True Study” of all vaccines? An alternate universe. 

Multiple studies in multiple countries using multiple research models and multiple research groups, with multiple funding sources, have found no link between vaccines and autism. They have also found no links between vaccines and a long list of other conditions, such as ADHD, asthma, diabetes and auto-immune disorders, that anti-vaccine propagandists attempt to link to vaccinations.

These studies have been dismissed by those anti-vaccine propagandists as having the wrong funding source, the wrong research design, the wrong focus, not separating out antigens from other vaccine ingredients, separating antigens from other vaccine ingredients inappropriately, not testing this or that, or some other reason that likely lacks validity.

Meanwhile, those in the anti-vaccine movement want ONE study. The One Study To Rule Them All. The One Study that tests every possible aspect of every vaccine and finds them all, together and separately, through this One Study, to be completely effective and completely safe for all children and not linked to any conditions.

Basically, anti-vaccine propagandists are asking for the following (they may not realize that this is what they’re demanding, but the expectations of valid research design would require these conditions):

1. Eliminate the use of all vaccines immediately in every country on the planet. Immediately — regardless of any public health concerns that exist.

2. Randomly sample an acceptable number of children with similar characteristics for an experimental group and a control group for each of the group configurations discussed below (in #4).

The numbers in each group would need to be in the hundreds or thousands to satisfy statistical requirements for validity and significance, and would have to include children from every country, every ethnicity, every socioeconomic status, with every possible genetic combination from parents, and of every possible health history based on parental family health.


It is a common tactic of anti-vaccine propagandists to claim that such-and-such vaccine can be a problem for children with this or that genetic make-up or some other characteristic – they frequently move the goalposts in making this argument – so the One Study would need to account for all those potential variations.)

Anti-vaccine propagandists have rejected studies with 3,000 or more participants, so each group below would likely need to contain huge numbers in order to satisfy them. (But then again, many of them accept 12 subjects – the number in Andrew Wakefield’s fraudulent and retracted case study – as valid, so who knows?)

Anti-vaccine propagandists are fond of saying “There are plenty of un-vaccinated kids already, so just use them!” However, researchers cannot use pre-existing groups who selectively vaccinate or do not vaccinate at all because research has shown that families that don’t vaccinate differ from families that do vaccinate, and those pre-existing differences would be a confounding variable in the study.


That is, it would be impossible to tell whether any conditions or differences in effects in the children occurred because of receiving/not receiving vaccines or because of the other inherent differences between families who do and families who don’t vaccinate.

To do a credible study of the kind that the anti-vaccine propagandists are demanding, then, researchers MUST randomly sample children and then MUST randomly assign them to the groups below. Parents would therefore have no choice about whether their children were assigned to a group receiving vaccines or a group not receiving vaccines.

3. Obtain permission from parents of children in each group to administer an injection into their child. The parents and children will not know what injection the child is receiving. The parents would not be allowed to have their children receive any injection from any other source, to avoid contamination of the data. Some children in the study would be completely unprotected from any disease outbreak, and their parents would be unaware of whether or not the children were unprotected.

4. The injection received may contain any of the following configurations:

a. Just saline. This comparison (or “control,” in scientific terms) group would be necessary for every single group involved in the study. No one in this group would receive any ingredient of any vaccine ever, just injections of saline.

b. Just the antigen, in saline. (An antigen is the inactivated pathogen – the virus or bacterium – or portions of it, or a weakened version of the live pathogen, which the body recognizes as an intruder and causes the immune system to build up the white blood cells that could fight the real deal later on.)

c. Just one ingredient of the vaccine (e.g., formaldehyde), in saline.

d. Two or more of the ingredients, in various combinations (e.g., formaldehyde and the antigen, formaldehyde and the aluminum salts, the antigen and the aluminum salts, etc.). For example, according to the CDC pink book, the MMR-II (measles, mumps, rubella) vaccine contains these ingredients:

i. Vitamins

ii. amino acids

iii. fetal bovine serum

iv. sucrose

v. sodium phosphate

vi. glutamate

vii. recombinant human albumin

viii. neomycin

ix. sorbitol

x. hydrolyzed gelatin

xi. chick embryo cell culture*

xii. WI-38 human diploid lung fibroblasts*

*These two items are not actual ingredients present in the final formulation of the vaccine, but they are used in the production of it, and, presumably, those calling for this sort of study would want to see “evidence” that using these ingredients during the course of vaccine production is not “unsafe.”

So, starting with the first ingredient on the list, researchers would have to have a group that received every single vitamin injected, every single vitamin in combination with every single other vitamin, in combination with multiple of the other vitamins, etc. Let’s say there are four different vitamins (A, B, C, D). There would have to be an A only group, a B only group, a C only group a D only group, an A/B group, an A/C group, an A/D group, a B/C group, a B/D group, a C/D group, an ABC group, an ABD group, an ACD group, a BDC group, and an ABCD.

That’s 15 comparison groups for four ingredients – and that is only for the vitamins, one of the 12 ingredients in the MMR vaccine (not including any part of the actual measles, mumps or rubella viruses). Then, researchers would have to include a group for each vitamin in combination with each other ingredient – vitamin A combined with sucrose, B with sucrose, D with sucrose, etc. Then each ingredient would have to be tested in various combinations with other ingredients. This would add up to thousands of groups, each having hundreds or thousands of children to cover all combinations mentioned above.

The above breakdown of possible combinations would have to be repeated for every vaccine, for every booster and for every possible combination of boosters.

5. Researchers would be expected to follow every single child in every single group throughout the course of their entire lifetime (which, with current life expectancy, can be 70-80 years in developed countries), monitoring every medical/health condition that develops, and comparing the rates for those conditions between each and every group above. If one of the thousands of study groups lost a single participant (through moving, withdrawal, death, etc.), then anti-vaccine propagandists would declare the study null and void, even though such attrition is to be expected, and is controlled for in the study design.

6. For each and every group mentioned above, a control group would have to exist, in which the children received no injection at all, of anything. No saline, no antigen, nothing.

7. Remember that the anti-vaccine movement wants each vaccine tested individually, THEN see the vaccines tested in combinations. So, one generation of children would have to receive the above breakdown of ONE vaccine over an entire lifetime, then another generation of children receiving the above breakdown of ANOTHER vaccine over an entire lifetime, etc., until all vaccines have been tested individually. (It’s unlikely that enough children in one generation would exist to meet the requirements of all those groups for each individual vaccine, so the complete study would require multiple generations.)

Then, and only then, do researchers start testing vaccine boosters. Then after that, they test vaccines in combinations, but only two at a time. Then three at a time. This requirement would mean that the study that would fit the criteria demanded – the One True Study – would last until approximately the heat death of the sun.

We haven’t yet discussed the ethics of the various groups (spoiler: It wouldn’t pass muster with any ethical board), the sampling difficulties or the enormous amounts of money that would be required (money that could not come from any government, any governmental agency, any institution of higher education or any scientist who’s ever done vaccination research in their career).

At this point, it should be apparently that such a study is not possible.

It’s also not necessary.

Various studies have addressed various aspects of each of the embedded questions in the above scenarios, and in combination, those answers address the concern of the anti-vaccine movement.


For example, aluminum salts (not elemental aluminum, as is claimed) are one ingredient used in vaccines. These are used as an adjuvant, a substance that induces a stronger immune response so that less antigenic material is required. The safety of this particular adjuvant has been well established. That’s just one meta-analysis of the studies of the safety of one ingredient. It’s not part of The One Study that anti-vaccine propagandists want, though, so they reject it.

Meanwhile, there are other meta-analyses about aluminum salts, and about other adjuvants and about all the various other ingredients in vaccines, not including the clinical trials that the vaccines went through before licensure and the many post-licensure studies about individual vaccines and about combinations of vaccines.

Think of all these studies – thousands and thousands of them – as a jigsaw puzzle. The puzzle isn’t one piece. It is composed of many pieces that fit together, creating a complete picture. The big picture on vaccinations is that they are safe and save lives. For individuals with conditions counter-indicating one or more vaccines, studies have already identified those conditions and the risks to guide clinicians. More studies are being done all the time to keep an eye out for developing risks.

Science is a process. Science is not about The One Study. It’s about ALL the studies.


About Allison Hagood

Allison Hagood is a professor of psychology and author with a background in the diagnosis and treatment of adult mental disorders (with a specialization in schizophrenia), cognitive psychology, life-span development and neuroscience. Hagood recently coauthored a book on the vaccine controversy, providing information to support a parent's decision to vaccinate their children, entitled Your Baby's Best Shot: Why Vaccines Are Safe and Save Lives.

The Myth of Learning Styles "Debunked"

From Educational Technology and Mobile Learning

December 22, 2013

Developments in cognitive science have had some far reaching impacts on learning theories. For instance , Howard Gardner's theory of multiple intelligences has its repercussions in learning styles theory.

A whole new body of substantiated and scientific knowledge was subsequently produced to encapsulate the core principles undergirding the multiple intelligences theory in educational literature. New instructional methodologies emerged to account for the different learning styles of students.

No two human beings are the same and therefore, the way they learn and process information is not necessarily the same. Some learn better through visual aids, others find it easy to learn when they are engaged in hands-on activities involving not only their intellectual abilities but also their body parts ( Kinesthetics).

On the face of it, the multiple learning styles theory seems to offer a plausible explanation to the differences exhibited in students learning habits. However, there is another side to the story. The graphic below from elearning infographics captures this side pretty throughly. It features eight arguments against the multiple learning styles theory. I invite you to check them out below. Enjoy!


Thursday, December 26, 2013

Skip the Supplements

From The New York Times

By Paul A. Offit, M.D. and Sarah Erush
December 14, 2013



Parents whose children are admitted to our hospital occasionally bring along something extra to help with their care: dietary supplements, like St. John’s wort to ameliorate mild depression or probiotics for better health.

Here’s the problem: The Joint Commission, which is responsible for hospital accreditation in the United States, requires that dietary supplements be treated like drugs. It makes sense: Vitamins, amino acids, herbs, minerals and other botanicals have pharmacological effects. So they are drugs.

But the Food and Drug Administration doesn’t regulate dietary supplements as drugs — they aren’t tested for safety and efficacy before they’re sold. Many aren’t made according to minimal standards of manufacturing (the F.D.A. has even found some of the facilities where supplements are made to be contaminated with rodent feces and urine). And many are mislabeled, accidentally or intentionally. They often aren’t what they say they are. For example:

In 2003, researchers tested “ayurvedic” remedies from health food stores throughout Boston. They found that 20 percent contained potentially harmful levels of lead, mercury or arsenic.

In 2008, two products were pulled off the market because they were found to contain around 200 times more selenium (an element that some believe can help prevent cancer) than their labels said. People who ingested these products developed hair loss, muscle cramps, diarrhea, joint pain, fatigue and blisters.

Last summer, vitamins and minerals made by Purity First Health Products in Farmingdale, N.Y., were found to contain two powerful anabolic steroids. Some of the women who took them developed masculinizing symptoms like lower voices and fewer menstrual periods.

Last month, researchers in Ontario found that popular herbal products like those labeled St. John’s wort and ginkgo biloba often contained completely different herbs or contaminants, some of which could be quite dangerous.

The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. And yet few consumers know this.

Parents of children admitted to our hospital often request that we continue treating their child with dietary supplements because they believe in them, even if that belief isn’t supported by evidence.


More disturbing were the times when children were taking these supplements without our knowledge. Doctors always ask parents if their children are taking any medicines. Unfortunately, because most parents don’t consider dietary supplements to be drugs, we often never knew about their use, let alone whether they might react dangerously with the child’s other treatments.

The F.D.A. has the mandate, but not the manpower, to oversee the labeling and manufacture of these supplements. In the meantime, doctors — and consumers — are on their own.

Our hospital has acted to protect the safety of our patients. No longer will we administer dietary supplements unless the manufacturer provides a third-party written guarantee that the product is made under the F.D.A.’s “good manufacturing practice” (G.M.P.) conditions, as well as a Certificate of Analysis (C.O.A.) assuring that what is written on the label is what’s in the bottle.

The good news is that we’ve been able to find some vitamins, amino acids, minerals and a handful of other supplements that meet this standard. For example, melatonin has been shown to affect sleep cycles and has a record of safety, and we identified a product that met manufacturing and labeling standards.

The bad news is that this was a vanishingly small percentage of the total group. Around 90 percent of the companies we reached out to for verification never responded. They didn’t call us back, or their email or manufacturing addresses changed overnight. Of the remainder, many manufacturers refused to provide us with either a statement of G.M.P. or a C.O.A.; in other words, they refused to guarantee that their products were what they said they were.


Others lied; they said they met G.M.P. standards, but a call to the F.D.A. revealed they had been fined for violations multiple times. Perhaps most surprising, some manufacturers willingly furnished information that their product didn’t meet standards — like one company that provided a C.O.A. showing that its product contained 47,000 International Units of beta-carotene, when the label stated 25,000.

Now, when parents in our hospital still want to use products whose quality can’t be assured, we ask them to sign a waiver stating that the supplement may be dangerous, and that most have not been studied for their effectiveness. “Use of an agent for which there are no reliable data on toxicity and drug interactions,” the waiver reads, “makes it impossible to adequately monitor the patient’s acute condition or safely administer medications.”

What can other individuals who are concerned about supplement safety do? They can look for “U.S.P. Verified” on the label — this proves the supplement has been inspected and approved under the United States Pharmacopeial Convention. Unfortunately, fewer than 1 percent of the 55,000 or so supplements on the market bear this label.


The real answer is that, until the day comes when medical studies prove that these supplements have legitimate benefits, and until the F.D.A. has the political backing and resources to regulate them like drugs, individuals should simply steer clear.

For too long, too many people have believed that dietary supplements can only help and never hurt. Increasingly, it’s clear that this belief is a false one.


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Paul A. Offit is chief of the division of infectious diseases at the Children’s Hospital of Philadelphia, where Sarah Erush is the clinical manager in the pharmacy department.

Assessing Autism the ADTree Classifier Way

From Questioning Answers

By Paul Whiteley
April 11, 2012

The Autism Diagnostic Observation Schedule (ADOS) has a hallowed place in autism research and practice. At 23 years of age, ADOS and its counterpart, the Autism Diagnostic Interview (ADI), have pretty much cornered the gold-standard autism assessment market over the years.

ADOS in particular, with its sliding scale of modules covering the spectrum of language and developmental ability and generous assortment of 'props', resides in quite a few cupboards of child development centres and research institutes worldwide.

One of the nice things about ADOS aside from the hands-on, interactive tasks particularly in the more 'early-years' modules, is the way that it valiantly attempts to standardise behaviour and codes autism, autism spectrum or not via the use of an algorithm.


This paper, headed by one of the primary architects of ADOS, Cathy Lord, summarises the development of that algorithm based on the ADOS-G (generic). Said algorithm having fairly recently been revised by Katherine Gotham and colleagues to amalgamate some features (communication + social interaction = social affect) potentially tied into the proposed revisions for autism diagnosis in DSM-V.

Perfect you might say, so if it ain't broken why fix it? Well, gold standard or not, ADOS can be quite time-consuming to deliver (but not as time-consuming as the ADI I might add). Assessors also need to be properly trained and kept up-to-date with their ADOS training, and despite all its standardised prowess, people are people and sometimes mistakes are made - which is partly why ADOS is an assessment tool and not an all-encompassing diagnostic tool.

Of course there are other 'issues' that have been raised with ADOS in mind (e.g. comorbid ADHD interfering, assessing Asperger's Syndrome), but I'm not here to start that critique.

Enter then a study by Dennis Wall and colleagues* (full-text) and their suggestion that based on some clever machine-learning algorithms, 8 out of the 29 items normally used in the delivery of a module 1 ADOS (no speech present) might just have the ability 'to classify autism' with complete or near 100% accuracy.
  • Wall and colleagues constructed 16 possible machine-learning algorithms based on the 29 coding items of the ADOS module 1. For anyone really interested, these 29 items are spread across several domains including: (a) language and communication (9 items including vocalisations, response to name, pointing and use of gestures), (b) reciprocal social interaction (11 items including eye contact, giving, requesting, showing and response to joint attention), (c) play (2 items - functional object play and imagination), (d) restricted, repetitive behaviours and interests (4 items including unusual sensory interests and hand / finger mannerisms) and (e) 'other abnormal behaviours' (3 items including overactivity and anxiety). I should point out that when it comes to the final algorithm, only 17 of these 29 items are actually used (at least according to the original pre-Gotham algorithm - the revised algorithm uses 14 items I think??) and even then, only 12 items contribute to the autism / autism spectrum cut-off scores used based on items in the communication and social domains.
  • Based on the use of data from a group of children with autism with module 1 ADOS scores from the AGRE dataset (autism: n=612; non spectrum: n=11), 90% of participants were used as part of a training set and the remaining 10% as a tester set as part of the proposed algorithms (much the same way that other studies have used).
  • Further validation of the best classifiers was undertaken based on other independent samples who reached cut-offs from module 1 ADOS to include data from the Boston Autism Consortium (autism: n=110; non spectrum: n=4) and the Simons Simplex Collection (autism: n=336; non spectrum: n=0).
  • Although 2 out of the 16 algorithms "operated with perfect sensitivity, specificity and accuracy", one of them, the ADTree classifier, was selected as the best option because it relied on only 8 items of the module 1 ADOS to produce such results (the alternative used a whopping 9 items). Validation using the Autism Consortium and Simons Simplex Collection data correctly classifying all but 2 participants (from the Simons collection) who exhibited "... the potential presence of non spectrum behaviours".
  • Drum-roll for the 8 distinguishing module 1 items isolated: (i) frequency of vocalisation directed to others, (ii) unusual eye contact, (iii) responsive social smile, (iv) shared enjoyment in interaction, (v) showing, (vi) spontaneous initiation of joint attention, (vii) functional play with objects and (viii) imagination/creativity. Use of these 8 items would also reduce the number of activities needed to elicit behaviours; so goodbye 'response to name' and 'response to joint attention'. I'm glad to say that the 'birthday party' activity remained!

Despite the obvious issues concerning a reliance on pre-ADOSed children and the use of only a handful of non spectrum controls, I find myself very interested in these results and the performance of the ADTree classifier. As per the study conclusions "The ADTree classifier consisted of eight questions, 72.4% less than the complete ADOS Module 1".

Purely from a practical point of view and the quite significant levels of concentration needed to manage tasks and elicit scores from the original module 1 ADOS, there is an obvious advantage to focusing on 8 items as opposed to 29 items. I do wonder exactly how much time will be shaved off an assessment bearing in mind that the majority of module 1 activities still need to be covered in order to elicit proper responses to items.

So, activities like 'free play', 'functional and symbolic imitation' and 'birthday party' are still required and can often take up the lion's share of assessment time.

Whilst the 8 selected items are interesting, there are some notable absences from the classifiers based on things like issues with pointing, the use of gestures and the use of facial expressions directed to others. I was always under the impression that these were important facets of autism, or at least autism in the early years but this study suggests not so in terms of classification.

What exactly this might say for other results linking pointing, proto-declarative pointing for example, to autism is source for speculation.

Homing in on those classifier items also opens a number of doors to things like quick and early screening and even where attention perhaps needs to be focused with regards to measuring outcome - that is how maturation and/or intervention may impact on core symptoms (at least for young and/or non-verbal people on the autism spectrum). Whether also this type of machine-analysis is applicable to other schedules related to autism screening and assessment is another question.

Reference

* Wall DP. et al. Use of machine learning to shorten observation-based screening and diagnosis of autism. Translational Psychiatry. April 2012.
DOI: 10.1038/tp.2012.10