Disclosures I have nothing to disclose Overview There are several - PDF document

• Neal Rojas, MD MPH Dangerous or • Associated Clinical Professor of Pediatrics Deadly • UCSF Department of Pediatrics “Cures” for • Division of Developmental Medicine Autism and Other • 19th Annual Developmental Disabilities: An Update for Health Professionals Developmental • March 5 ‐ 6, 2020 Disabilities Disclosures • I have nothing to disclose

Overview • There are several reports of injuries and deaths related to treatments of children with neurodevelopmental disabilities • We will review which types of therapies have been associated with this morbidity as well as how patients can be educated to make the safest choices while pursuing treatment for neurodevelopmental disabilities Learning Objectives • We will take a health education approach to describing risks and understanding what is prevalent in the treatment world today • We will then review specific treatments which can cause harm • We will then discuss a clinical approach which will allow for communication and collaboration in maximizing safety while pursuing efficacy in treating neurodevelopmental disabilities (NDD) • We will attempt to be humble in also remembering what is considered standard therapy is not always as safe as we’d like to think

Why Parents • Autism is perceived as a severe, Chose life ‐ long condition, resulting in a poor prognosis. Dangerous • Parents, new to the diagnosis, ”Cures” lack knowledge about the disorder, and maybe minimally trained in scientific inquiry. • Parents must deal with conflicting information and competing perspectives from professionals. Why Parents Chose ”Cures” THE FADS ARE OFTEN THERE IS INADEQUATE MEDS CAN ONLY PRESENTED AS QUICK INFORMATION ABOUT ALLEVIATE CERTAIN FIXES OR CURES. THE CAUSE OF AUTISM. SYMPTOMS. NO CURE. (METZ ET. AL.)

Role of Media Often shows Rarely able to go into preferential coverage of full scientific “breakthoughs” or breakdowns and ”miracles” methods of studies Often uses strident Celebrities can hijack denunciation of all attention over science previous treatments using a very powerful rather than building anecdotal ‘human face’ upon evidence approach to convince incrementally patients • ”a collection of beliefs or practices mistakenly regarded as being based on scientific method” (Websters Dictionary) “a system of theories and methods that has some resemblance to a genuine science but that cannot be considered such. Examples Pseudoscience include astrology, numerol ogy, and esoteric magic. ” (APA dictionary)

Uses some scientific jargon and concepts as well as research ‐ based evidence but does not fulfill burden of proof with controlled trials or How repeatability Pseudoscience Works Often relies on very small studies with leaps of faith in logic that they generalize across real clinical applications (APA) Pseudosci eudoscience nce can • Snake Oil ‐ Little to no scientific move towards basis but popular due to cultural or persuasive testimonials Science with (Websters) increased rigorous study or towards ‐ >

• Several theories of what may cause ASD are avenues for current therapies: • These include: Oxidative stress; ASD “Abnormal Inflammation/immune Physiology” dysfunction; environmental toxins Theories • These are real lines of scientific inquiry across the globe of ASD researchers Evidence vs. Theories • While promising evidence for some treatments exists such as NAC *and Vitamin B12 • Other therapy modalities which ride on these theories such as chelation or hyperbaric oxygen ARE NOT SAFE! (Bent and Hendrin)

• MMS Top 5 Most • Chelation Dangerous • HBOT • Lupron Therapy aka Chemical Treatments Castration for ASD/NDD • Stem Cell Therapy MMS • “Miracle Mineral Solution” or MMS aka Chlorine Dioxine CD or AKEA • May cause immediate symptoms of esophageal burning • Long term GI issues because it’s BLEACH! (see poison center reference**) • Autism Research Institute (ARI) “ We advise against using Miracle Mineral Solution. We hope parents will remain critical of unsubstantiated claims that children have recovered or greatly improved in the absence of objective proof. We also strongly encourage any parents who choose to administer MMS to their children to report it to their physician so that side effects can be monitored.”

Dangerous Treatments: Chelation Therapy • Based on theory that heavy metal toxicity causes autism and other NDD • Given risks of renal/kidney damage and hypocalcemia/low Calcium (at least one documented death of 5 year old with ASD) • No evidence of efficacy from Cochran analysis in 2015 • FDA stated that chelators that are sold over the counter as treatments for autism, are dangerous and illegal. They stated that they are potent drugs that carry serious risks—including kidney damage, dehydration, and even death (Tsouderos, 2010). Dangerous Treatments: Hyperbaric Oxygen • Hyperbaric Oxygen Therapy (HBOT) used for several other conditions unfortunately lending credibility to it’s use for NDD • Some studies by HBOT advocates show mixed evidence of efficacy and some behavioral benefits. • More Common Risks include ear pain, tinnitus, exacerbation of anxiety. Some reports of more severe reactions including hyponatremia/low Sodium and seizures • Association for Science in Autism Treatment “In conclusion, at this time, there is no quality empirical research, meeting standards of good science, that support the claim that HBOT is effective as a treatment for ASD. Equally important, the logic and fundamental assumption of using HBOT with individuals with ASD (i.e., to treat inflammation of the brain) is not substantiated and deserves skepticism.”

Lupron Therapy/Chemical castration • Chemical castration . • Introduced to the world of autism treatment by the now notorious father ‐ son team of the Geiers. These two, in a 20 ‐ year ‐ long run of damage, might now be reaching the end of their particular race. The father has had his medical license stripped in several states. That didn't stop the Geiers from filing a patent for their chemical castration protocol. Stem Cell Therapy • Also has some coattail credibility due to it’s use in leukemia and recent breakthroughs in blood disorders • “Stem cell therapy for autism is illegal in the United States, but that hasn’t stopped some from offering this as a treatment for autism in Costa Rica, China, and other countries. There is no evidence that the treatment is safe or effective for autism, and no guarantee that the stem cells used in these countries are even human .” (Autism Science Foundation) • Self placenta cell therapy protocals exist in U.S. at a prominent research university (these may be safer but do not currently offer a clear path to cure )

Standard Therapy (aka Allopathy) • Traditional Western Medicine with Biological/Scientific basis requiring proof of efficacy and safety (FDA) • Unfortunately, this has resulted in mostly just medications for symptoms rather than etiology management (“The Cure”) • Atypical Antipsychotic medications and neuroleptic medications such as risperidone, aripiprazole, and others are well associated with causing metabolic abnormalities such as insulin resistance and high cholesterol Standard Interdisciplinary Therapy or Multimodal Treatment • Interdisciplinary work with other types of therapy supporting children with NDD such as • Speech Therapy • Occupational Therapy • Physical Therapy • Cognitive Behavioral Therapy • Other Behavioral Therapies

Integrative Medicine ‐ CAM Again? • Given that Allopathy has not offered very much for NDD and ASD especially, the vast majority of families with ASD surveyed tried one or more CAM modalities. • These are often directed at the common co ‐ morbid challenges associated with NDD/ASD such as irritability, hyperactivity, sleep problems or GI symptoms. Integrative Medicine Approach to NDD • Growing amount of research looking at areas involving • nutrition, • supplements, • mind ‐ body therapies

References • Stephen James, Shawn W Stevenson, Natalie Silove, and Katrina Williams, “Chelation for autism spectrum disorder (ASD) Cochrane Database; Cochrane Database Syst Rev. 2015 May; 2015(5): CD010766. • Mary E. McDonald PhD , Darra Pace EdD , Elfreda Blue PhD & Diane Schwartz EdD ” Critical Issues in Causation and Treatment of Autism: Why Fads Continue to Flourish” 290 ‐ 304 | Received 01 Oct 2010, Accepted 07 Mar 2011, Published online: 06 Nov 2012 References • Plafki C, Peters P, Almeling M, Welslau W, Busch R. Aviat Space Environ Med. Complications and side effects of hyperbaric oxygen therapy. • 2000 Feb;71(2):119 ‐ 24. • Ghanizadeh A. Hyperbaric oxygen therapy for treatment of children with autism, a systematic review of randomized trials. Med Gas Res. 2012;2(1):13. doi: 10.1186/2045 ‐ 9912 ‐ 2 ‐ 13.[PMC free article] [PubMed] [CrossRef] [Google Scholar] • Rossignal DA et al. Hyperbaric oxygen treatment in autism spectrum disorders. Medical Gas Research. Published online 2012 Jun 15. doi: 10.1186/2045 ‐ 9912 ‐ 2 ‐ 16