Archive for the ‘sensory issues: sensory processing/integration’ Category
FDA warns OSR#1 is Toxic, Not Safe for Autism Treatment
“OSR#1 is not a dietary supplement but a toxic, unapproved drug with serious potential side effects” the FDA warns, says the June 23 Chicago Tribune article.
OSR#1 is an industrial chelator that is now being marketed as a supplement to treat autism.
According to CTI Science’s website, “OSR#1® is a toxicity free, lipid soluble antioxidant dietary supplement that helps maintain a healthy glutathione level”.
The FDA wrote a letter of warning to Boyd Haley, the president of CTI Science indicating that they are making unapproved claims:
Your firm markets OSR#l as a dietary supplement; however, this product does not meet the definition of a dietary supplement in section 201(ff) of theFederal Food, Drug, and Cosmetic Act,
“The claims listed above make clear that OSR#1 is intended to affect the structure or any function of the body of man or other animals. Accordingly, OSR#l is a drug under section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1). Disclaimers on your website, such as “OSR#l® is not a drug and no claim is made by CTI Science that OSR#1® can diagnose, treat or cure any illness or disease,” do not alter the fact that the above claims cause your product to be a drug.”
They go on to indicate that this new drug may not be introduced or delivered for ….interstate commerce…because there is no FDA-approved application in effect for the product.
“Additionally, under section 502(a) of the Act, 21 U.S.C. § 352(a), a drug is misbranded if its labeling is false or misleading in any particular”…”Your website states that” [s]ome reports of temporary diarrhea, constipation, minor headaches have been reported but these are rare and the actual causes are unknown,” as well as “OSR#1 is without detectable toxicity” and “OSR#1® … has not exhibited any detectable toxic effects even at exceptionally high exposure levels.” However, animal studies that you conducted found various side effects to be associated with OSR#1 use, including, but not limited to, soiling of the anogenital area, alopecia on the lower trunk, back and legs, a dark substance on lower trunk and anogenital area, abnormalities of the pancreas, and lymphoid hyperplasia. Based on these animal studies and side effects known to be associated with chelating products that have a similar mechanism of action to OSR#1, we believe the use of your product has the potential to cause side effects, and the before-mentioned website statements falsely assert that the product does not have the potential to cause side effects. Therefore, these statements render your product’s labeling false or misleading. ”
In response to prior Chicago Tribune articles, Boyd Haley was on Twitter stating ”
“Contrary to the Chicago Tribune implication, OSR1 has undergone extensive safety testing. The truth is at www.OSR1.com. Please retweet!”
However, on the OSR1.com website, there is no mention of these test results. There is a “safety and pharmacokinetics summary“, but it doesn’t discuss or cite the “extensive studies” .
The Tribune quotes Ellen Silbergeld, a John’s Hopkins researcher:
“It would be hard to imagine anything worse,” said Ellen Silbergeld, an expert in environmental healthwho is studying mercury and autism at Johns Hopkins University’s Bloomberg School of Public Health. “An industrial chemical known to be toxic — his own incomplete testing indicates it is toxic. It has no record of any therapeutic aspect of it, and it is being marketed for use in children.”
Kim Stagliano, Managing Editor of the “Age of Autism” blog has written in an email that was quoted in the Tribune Article : “I continue to trust his science,” . “I’m sure CTI Science will address the letter appropriately.” This physician-scientist is confused. Boyd Haley has not provided science to support that this agent is effective and safe to the FDA, and I cannot find any citations on his website to scientific research. Prof. Haley appears to have withheld safety information from the autism community. It is his own “science” that suggests this chemical is toxic.
Posted in 
Eating Disorders and the Brain’s Distortions of the Body
Scientists at the University College London have produced data suggesting, that our brains contain a highly distorted model of our own bodies
The study,published in Proceedings of the National Academy of Sciences, focused on the brain’s representation of the hand.
The brain’s model of the hand is one in which our fingers are perceived to be shorter and our hands fatter than they are.
Neuroscientists suspect the reason for these distortions may lie in the way the brain receives information from different regions of the skin.
Participants in the study were asked to put their left hands palm down under a board and judge the location of the covered hand’s knuckles and fingertips by pointing to where they perceived each of these landmarks to be. A camera situated above the experiment recorded where the participant pointed. By putting together the locations of all the landmarks, the researchers reconstructed the brain’s model of the hand, and revealed its striking distortions.
People estimated that their hands were about two-thirds wider and about one-third shorter than actual measurements.
Participants were also accurate in picking out a photo of their own hand from a set of photos with various distortions of hand shape, suggeting there is clearly a conscious visual image of the body as well.
The research is attempting to understand how proprioception works–in other words, “how does the brain know where all parts of the body are in space even when your eyes are closed”?
Neuroscientists think that “position sense” requires two distinct kinds of information. Signals that the brain receives from muscles and joints play an important role in position sense, but the brain also needs a model of the shape and size of each body part; to know where the fingertip is in space, the brain needs to know the angles of joints in the arm and hand, but also the length of the arm, hand, and finger.
Neuroscientists suspect that the brain’s distorted model of body shape is related to how the brain represents different parts of the skin. For example, the size of the brain representation of the five fingers gets progressively smaller for each finger between the thumb and the little finger, mirroring the relative size of fingers in the body model reported in this study.
These findings may be relevant to psychiatric conditions such as Anorexia nervosa and other eating disorders. It is possible that people tend to perceive the body as being wider than it is. Though the participants had an accurate visual image of their own body, it is possible that the distorted perception related to proprioception could dominate in some people, so that body image is distorted.
Evidence That Mirror Neurons Exist: May Provide New Understanding of Autism
A mirror neuron is a cell in the brain that fires when we observe another person perform an action. For example, if we watch another person pick up a cup, place it to their mouth and drink, mirror neurons fire, and give us an idea about how it feels to hold the cup, to lift the cup, to feel the cup touch our lips, to feel the liquid in our mouths.
Neuroscientists have hypothesized that mirror neurons are responsible for the human capacity to empathize with others, and to understand how another person might be thinking or feeling–how we can understand another person’s pain, how we understand how they are feeling when they smile. In the April edition of the journal Current Biology Dr. Itzhak Fried, a UCLA professor of neurosurgery and of psychiatry and biobehavioral sciences, Roy Mukamel, a postdoctoral fellow in Fried’s lab, and their colleagues (Arne D. Ekstrom, Jonas Kaplan and Marco Iacoboni) have provided the first direct evidence that mirror neurons truly exist, by making a direct recording of their actions, in the motor regions of the brain, as well as in regions responsible for vision and memory.
When a research subject performed an activity, specific subsets of mirror cells in the research subject’s brain increased their activity. When a research subject only observed another person performing an action, these subsets of mirror cells decreased their activity. The researchers hypothesize that the decreased activity from these subsets of mirror cells occurs to prevent an observer from automatically performing the action that they are observing the action of another person, and to help us distinguish our own actions from those of others.
The researchers implanted electrodes into the brains of 21 patients with intractable epilepsy, so that seizure foci could be identified for potential surgical treatment. The researchers obtained consent from the patients to use the same electrodes for their clinical research.
The experiment included three parts: facial expressions, grasping and a control experiment.
Activity from a total of 1,177 neurons in the 21 patients was recorded as the patients were asked to observe various facial expressions and grasping actions performed by others in videos on a laptop computer. They were then shown visually presented words and asked to perform the action. Finally, for the control task, the words were presented, and patients were instructed not to perform the action.
The mirror neurons in the medial frontal cortex (responsible for movement) and medial temporal cortex (responsible for memory) showed their greatest activity both when the individual performed a task and when they observed a task. This finding demonstrates that mirror neurons are located in more areas of the human brain than was previously thought, and that the mirror neurons provide detailed and complex mirroring of the actions of other people–and it is very likely this mirroring of others that helps us understand the actions, intentions, and feelings of others automatically.
This study is important because:
1. it provides evidence that mirror neurons–neurons that link the activity of the self with that of others–really exist
2. it suggests that the distribution of mirror neurons is wider than was previously thought
3. it is suspected that dysfunction of mirror cells may be involved in disorders such as autism, since autism is a condition where verbal and nonverbal communication, imitation, and empathy for others is impaired. If we can better understand the mirror neuron system, we may be able to find ways to treat this disorder.
The project was supported by the National Center for Research Resources, a component of the National Institutes of Health (NIH).