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A Review of Chelation Therapy in the Treatment of Autism

A Review of Chelation Therapy in the Treatment of Autism. Kelly Ann LaPietra Caldwell College. Source Identification. Keywords: “ chelation ”, “ chelation and autism” Assigned Textbooks Barnes and Noble bookstore “Special Needs Children section” Pubmed Database

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A Review of Chelation Therapy in the Treatment of Autism

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  1. A Review of Chelation Therapyin the Treatment of Autism Kelly Ann LaPietra Caldwell College

  2. Source Identification • Keywords: “chelation”, “chelation and autism” • Assigned Textbooks • Barnes and Noble bookstore “Special Needs Children section” • Pubmed Database • Academic Search Premier Database • Psychinfo Database • Google Scholar • Google Search Engine • Autism Resource Websites • References cited in articles and in books

  3. OUTLINE TOPIC: Chelation Therapy I. Introduction A. Origin of the word B. Description II. History III. Common Uses A. Unapproved B. Approved IV. Chelation & autism A. Theory B. Basis C. Contradictory evidence V. Video VI. Commonly Used Chelators A. Drug names B. Administration VII. Chelation Therapy A. Preparation B. Sample Treatment Regimen

  4. OUTLINE IIX. Testing A. Methods B. Provoked urine excretion test 1. Information gleaned 2. Limitations IX. Effects of Chelation Therapy A. Claimed benefit B. Side effects X. Treatment XI. A. Guidelines B. Qualifications C. End of treatment indicators D. Problems XII. Participating Doctors XIII. Research XIV. Any Evidence? XV. Points of View X. Pseudoscience

  5. Chelation Therapy • Derived from the Greek word chele, whichmeans “claw” • Named for the grabbing effect chelating agents have on metal molecules • Refers to the way certain synthetic chemical and body proteins can bind metal molecules Walker, Morton. (1990). The Chelation Way. NY: Avery Publishing Group.

  6. What is Chelation? • Detoxification process by which heavy metals are pulled from tissues and made water-soluble so they can be excreted through urine or stool. • Heavy metals have an affinity for the binding sites of chelators. • There are many different chelating agents and are selected for use based on the metal targeted for removal. Jepson, B. (2007). Changing the course of autism: A scientific approach for parents and physicians. Boulder, CO: Sentient Publications.

  7. HISTORY • First introduced into medicine to cure aresenic-based poison gas that was used in WWI • First chelating agent used was the organic dithiol compound dimercaprol AKA British Anti-Lewisite (BAL) • Large scale lead poisoning of Navy personnel in the wake of WWII, led to the use of EDTA • 1960’s DMSA began use (a modified form of BAL with less side effects) • EDTA and BAL were used less after introduction of DMSA • DMSA- became the mainstay for lead, arsenic, and mercury poisoning in the US Retrieved from http://research-chelation-therapy.com

  8. HISTORY • Former Soviet Union gave us DMPS, a mercury-chelating agent and ALA, a mercury and arsenic chelator • Today DMPS remains an experimental chelator; ALA is used as a nutritional supplement • EDTA approved by FDA for treating lead and heavy metal toxicity • American College for the Advancement of Medicine (ACAM) began claiming the restorative effects of EDTA in the treatment of atherosclerosis • 1998, Federal Trade Commission (FTC) argued against this misrepresentation, citing a lack of evidence • 1999, ACAM no longer advertised this claim Retrieved from http://research-chelation-therapy.com

  9. A Note of Caution “NOTE: Due to pharmacological property differences and mechanisms of action, each drug agent should be used as indicated by the FDA or off label usage noted. CIGNA HealthCare does not cover Chelation Therapy for the following indications because they are considered experimental, investigational or unproven!” Retrieved from www.cigna.com

  10. What is chelation being used for? • • atherosclerotic vascular diseases • • coronary artery disease • • reperfusion injury during coronary angioplasty or cardiopulmonary bypass surgery • • progressive renal insufficiency in Type II diabetic nephropathy • • Alzheimer’s disease • • Parkinson’s disease • • primary biliary cirrhosis • • ankylosingspondylitis • • autism • • glioblastoma • • scleroderma • • porphyria • • hypercholesterolemia Retrieved from www.cigna.com

  11. Chelating Agents & the Condition they Treat Coverage Policy CIGNA HealthCare covers each respective Chelation Therapy agent as Medically necessary when it is used for its usage/FDA approved indication and associated condition as listed in the table below: DRUGS: Edetate Calcium Disodium (Calcium EDTA) (Calcium Disodium Versenate®) Succimer (DMSA) (Chemet®) CONDITION: heavy metal overload or toxicity (e.g., lead, arsenic, mercury, iron, copper, or gold) confirmed by appropriate laboratory results (e.g., blood, plasma, and/or urine) or clinical findings consistent with metal toxicity Retrieved from www.cigna.com

  12. CHELATION AND AUTISM THEORY: Children with autism carry a toxic heavy metal body burden (Bernard, S., Enayati, A., Redwood, L., Roger, H., & Binstock, T., 2001). RATIONALE FOR TX: Chelating agents will remove the offending toxins from the body and the symptoms of autism will decrease.

  13. What evidence are they basing this theory on? • Low levels of mercury found in baby hair of children with autism compared to controls (Holmes, A. S., Blaxill, M. F., & Haley, B. E., 2003). • High levels of mercury in baby teeth of children with autism compared to controls (Adams, J. B., Romdalvik, J., Sadagopa, V. M., & Legator, M. S., 2007). • Higher mercury excretion after a 3-day treatment with DMSA in children with ASDs compared to controls (Bradstreet, J., Geier, D. A., Kartzinel, J. J., Adams, J. B., & Geier, M. R., 2003)

  14. CONTRADICTORY EVIDENCE • Williams, Hersh, and Sears (2008) found that there were no significant differences between mercury levels in hair of children with autism and their typically developing siblings. • In 2007, Soden, Lowry, Garrison, and Wasserman found that when a 24-hr DMSA provoked excretion test was administered to children with autism there was no measurable increase in excretion of toxic metals.

  15. VIDEO • Dateline MSNBC (2006): Interview with Dr. Jim Adams http://www.youtube.com/watch?v=FHkr4l12veI http://www.youtube.com/watch?v=4eyJb-izu6M&NR=1

  16. 4 Most Commonly Used Chelators in the Treatment of Autism • DMSA (dimercaptosuccinic acid)* • EDTA (Calcium EDTA) * • DMPS (2, 3-dimercapto-1-propanesulfonic acid) Jepson, B. (2007). Changing the course of autism: A scientific approach for parents and physicians. Boulder, CO: Sentient Publications. • TTFD (thiamine tetrahydrofurfuryl disulfide) Lonsdale, D., Shamberger, R. J., & Aduhya, T. (2002). Treatment of autism spectrum children with thiamine tetrahydrofurfuryl disulfide: A pilot study. Neuroendocrinological Letters, 23, 303- 308.

  17. How are they administered? • Orally • Transdermally • Intravenously • Rectally (suppositories) Jepson, B. (2007). Changing the course of autism: A scientific approach for parents and physicians. Boulder, CO: Sentient Publications.

  18. PREPARATION FOR CHELATION THERAPY FOR AUTISM • Reduce exposure to toxins Ex. Consuming organic foods and drinking reverse osmosis water, remove mercury dental fillings, avoid pesticide use • Improve levels of essential vitamins and minerals • Improve glutathione levels • Treat gut dysbiosis Retrieved from www.autism.com

  19. RECOMMENDED TREATMENT REGIMEN According to the Treatment Options for Mercury/Metal Toxicity in Autism and Related Developmental Disabilities: Consensus Paper (2005), chelation treatment should be administered as follows: • Oral/Rectal Suppository - 3 days of Tx, followed by 11 days off • Transdermal- Tx on alternating day schedule • TTFD: Oral, Transdermally, Rectal Suppository- no Tx recommendations

  20. How are metals being tested? • Hair • Stools • Urine • Blood • Baby teeth Jepson, B. (2007). Changing the course of autism: A scientific approach for parents and physicians. Boulder, CO: Sentient Publications.

  21. PROVOKED URINE EXCRETION TEST • AKA Diagnostic Chelation Challenge PROCEDURE: Levels of toxic metals are measured in the urine before the dose of chelator is administered and then urine is collected for 6-8 hours after and a sample of the accumulation of urine is tested. RISK: short-term, if any. RATIONALE: Metals tend to hide in the body and these hidden metals are not reflected by evidence-based testing methods Zhiping, Y., Wu, Q., & Fan, D. (2009). Inappropriate diagnosis and chelation treatment of alleged heavy-metal toxicity. Annals of Internal Medicine. 151, 8.

  22. What an Increase in Toxic Metals in Urine tells us after Administration of a Challenge Dose of Chelator 1. Metal was present in the body 2. Chelator was able to assist in excretion of metals Zhiping, Y., Wu, Q., & Fan, D. (2009). Inappropriate diagnosis and chelation treatment of alleged heavy-metal toxicity. Annals of Internal Medicine. 151, 8.

  23. LIMITATIONS OF PROVOKED TESTING 1. No provoked excretion reference range for comparison. 2. Collecting urine for less than 24-hrs. is not representative of excretion levels. 3. Provocation has been shown to artificially increase the 24-hour average urine mercury level. Zhiping, Y., Wu, Q., & Fan, D. (2009). Inappropriate diagnosis and chelation treatment of alleged heavy-metal toxicity. Annals of Internal Medicine. 151, 8.

  24. CLAIMED BENEFITS OF CHELATION TREATMENT FOR AUTISM Highly effective in: • removing toxic metals • improving glutathione • normalizing platelets (a marker of inflammation) Adams, J. B., Baral, M., Geis, E., Mitchell, J., Ingram, J., Hensley, A., Zappia, I., Newmark, S., Gehn, E., Rubin, R. A., Mitchell, K., Bradstreet, J., and El-Dahr, J. (2009). Safety and efficacy of oral DMSA therapy for children with autism spectrum disorders: Part A-Medical results. BMC Clinical Pharmacology, 9, doi:10.1186/1472-6904-9-16. Possibly beneficial in: • reducing the symptoms of autism • Rapid progression of language ability • Improved social interaction • Improved eye contact • Decreased Self-stimulatory behaviors • Improvement in both strength and coordinator Retrieved from www.autism.com

  25. POTENTIAL SIDE EFFECTS OF CHELATION I • toxic epidermal necrolysis (TEN) • thrombocytopenia • erythemamultiforme (Stevens-Johnson syndrome) • cardiac arythmias • hepatic enzyme elevation • hemolytic anemia • neutropenia • neuropathies • renal dysfunction • essential mineral depletion • potential for medical errors • death Zhiping, Y., Wu, Q., & Fan, D. (2009). Inappropriate diagnosis and chelation treatment of alleged heavy-metal toxicity. Annals of Internal Medicine. 151, 8. Retrieved from www.autism.com

  26. POTENTIAL SIDE EFFECTS OF CHELATION II • abdominal cramps • various dermatological symptoms • diarrhea • vomiting • convulsions • severe constipation • bowel paralysis • acute toxicity • allergic reactions (Freeman, 2007) • brain damage (Strangle, D. E., Smith, D. R., Beaudin, S. A., Strawderman, M. S., Levitsky, D. A., & Strupp, B. J., 2007) • regression in language and behavior • clinical symptoms of mercury poisoning Retrieved from www.autism.com

  27. GUIDELINES FOR CHELATION THERAPY • For lead poisoning, candidates are individuals with lead levels of >45mcg/100mL in their blood-only approved standard • Mineral and vitamin supplements should be given before, during, and after chelation therapy • Should be done under supervision of a physician • Kidney and liver function must be evaluated regularly • White blood cell count must be monitored Adams, J. (2010). Chelation: Removal of toxic metals. In K. Siri & T. Lyons (Eds.), Cutting Edge Therapies for Autism (pp 74- 78). NY: Skyhorse Publishing.

  28. QUALIFICATIONS FOR CHELATION THERAPY • No standard excretion level • Dr. Neubrander’s office: children’s urine excretion is categorized as in the normal, elevated, or highly elevated range, with those in the highly elevated range qualifying for chelation; based on a provoked urine test (6-8 hr. sample). R. Neubrander, personal communication, June 1, 2010

  29. END OF TREATMENT INDICATORS • At least until urinary collections reveal only modest amounts of toxic metals • When improvement ceases • If the child shows no significant progress during therapy or if they experience regression Retrieved from www.autism.com • Begin chelating with an agent that preferentially binds to a different metal than the one already chelated with Adams, J. (2010). Chelation: Removal of toxic metals. In K. Siri & T. Lyons (Eds.), Cutting Edge Therapies for Autism (pp 74- 78). NY: Skyhorse Publishing.

  30. PROBLEMS WITH CHELATION IN CHILDREN WITH AUTISM • Measures of unprovoked blood and urine reflect only acute, ongoing exposure, and are not a reflection of tissue levels or total body burden make it difficult to assess metal toxicity in the body. • There are no set standards for determining what qualifies as an abnormal or dangerous level in the general population on provocation challenges. • Single provocation challenge tests can be misleading in determining total body burden because of metal’s tendency to compartmentalize in the body. • There are no universal standards of qualifications for chelation therapy or for treatment protocol. Jepson, B. (2007). Changing the course of autism: A scientific approach for parents and physicians. Boulder, CO: Sentient Publications.

  31. Where can your child get chelated locally? • DAN! Physicians affiliated with Autism Research Institute Directory www.autism.com • New Generation Medical Doctors affiliated with Generation Rescue Directory www.generationrescue.org

  32. HOW DO YOU BECOME… • a DAN! physician? 1. Be a medical doctor 2. Sign the ARI/DAN! philosophy statement 3. Pay $250 4. Attend a professional seminar 1x/2 years Retrieved from www.autism.com • A New Generation Medical Doctor? 1. Be an M.D. or D.O. 2. Share the philosophy or Autism Research Institute Retrieved from www.generationrescue.org

  33. RESEARCH In a pilot study, Lonsdale et al. (2002) explored the effects TTFD have on children with autism. PARTICIPANTS: 10 children diagnosed with autism TREATMENT: 2x/day rectal suppository containing TTFD for 60 days MEASURE: Clinical effects-ATEC FINDINGS: Autistic spectrum symptoms improved in 8/10 children CONCLUSION: “TTFD might be valuable in the treatment of this devastating and increasingly common disease in children.”

  34. LIMITATIONS • Other therapies were allowed to continue • Group design masks individual results • No control group • Employed use of hair analysis as one of its measures

  35. RESEARCH In 2004, Dietrich et al. explored the effect DMSA would have on standardized tests of neurodevelopment at age 7 versus controls for children who presented with blood lead levels slightly below lead poisoning level. DESIGN: Randomized, double-blind placebo-controlled trial PARTICIPANTS: 780; 647 @ completion TREATMENT: 6-13 month administration of DMSA + daily vitamin or placebo FINDINGS: Blood level levels were lowered by DMSA Tx, but no benefit in cognitive, behavioral, and neuromotor endpoints

  36. RESEARCH A controlled study by Strangle et al. (2007 ) looked at risks/benefits of succimer in the tx of lead poisoning in rats. • Tx group rats exposed to neurotoxic levels of lead poisoning and then injected with succimerchelator • Control group rats with no lead poisoning were injected with succimerchelator FINDINGS: 1. Learning ability returned to normal in the Tx group Matches hypothesis that lead in the brain impairs brain function 2. Test scores went down in the control group- actually doing as poorly as the lead-poisoned rats CONCLUSIONS: Chelation is an effective treatment for lead poisoning, but with no lead to pull from the control rats’ brains, the succimer started attacking the brain cells themselves. REPERCUSSIONS: In 2008, the National Institutes of Health canceled a controlled trial of succimer treatment in children with ASD because of the risk of brain damage from succimer.

  37. RESEARCH In 2009, Dr. James Adams et al. published a randomized, double-blind investigation of the effect oral DMSA therapy has on children with autism. • 2-part study (Part A: Medical Results, Part B: Behavioral Results) • Phase 1: All 65 participants (3-8yrs old) received a round of DMSA to screen for excretion level. • Those with high urinary excretion of toxic metals (49/65) were randomly assigned to either a Tx or control group. • Phase 2: Tx group- 6 more rounds of DMSA therapy Control group- 6 rounds of placebo

  38. RESEARCH Children with ASD Randomized in double-blind manner Topical Glutathione 7 days Placebo Cream Phase 1 1 round of oral DMSA 3 doses/day 1 round of oral DMSA x 3 days Metal excretors Metal excretors Phase 2 6 rounds DMSA 6 rounds of placebo NOTE: 4 discontinued study due to adverse side effects.

  39. RESEARCH How were they measuring effects? Parental Assessments • Pervasive Developmental Disorder Behavior Inventory (PDD-BI) • Autism Treatment Evaluation Checklist (ATEC) • Severity of Autism Scale (SAS) • Parent Global Impressions (PGI) Trained Evaluator • Autism Diagnostic Observation Schedule (ADOS)

  40. RESEARCH FINDINGS: In a single round for all groups, glutathione and platelet counts were normalized-making study more a comparison of 1 vs. 7 rounds of DMSA. Those in the 7-round group continued to excrete metals (PART A). FINDINGS: The severity of autism significantly decreased during the study for both the Tx and control groups (PART B).

  41. LIMITATIONS • Urine collection for only 8 hours • Parents rated behavior change • “Lost” placebo comparison • Arbitrarily chosen level for qualification into Phase 2; above Doctor’s Data reference range- top 95% for typical children not undergoing chelation therapy • Nature of group design average may not reflect the effect for any one participant • Treatment and placebo group did not differ in treatment effects

  42. SOME POINTS OF VIEW • www.asatonline.org- does not endorse it, citing that it is not an evidence-based treatment for autism • www.autismspeaks.org- cautions parents to research available treatments • www.autismnj.org- endorses those treatments that are science-based and have proven effectiveness

  43. American Academy of Pediatrics “Preliminarydata from the Centers for Disease Control does not suggest a relationshipbetween thimerosal-containing vaccines and ASD.180 Hair analysis is not recommended for biomonitoring, because falseelevations may occur if the specimen is not carefully collected.Provocative chelation tests for mercury have not been scientificallyvalidated and are also not recommended. Several chelating agents,including succimer, dimercaprol, d-penicillamine, and N-acetylcysteine,have been shown to accelerate mercury elimination from the body.181 However, there is no evidence that chelation therapy will improvedevelopmental function when given to treat mercury toxicosis.Moreover, chelating agents can have significant toxicity (eg,hepatotoxicity) and precipitate allergic reaction.182Chelation therapy is therefore not recommended for the purposeof improving neurodevelopmental function in children with ASD.” Committee on Children with Disabilities, 2001. Technical Report: The Pediatrician’s Role in the Diagnosis and Management of Autistic Spectrum Disorder in Children. Pediatrics, 107, e85.

  44. Any Evidence? • Based on the theory that autism is a result of heavy metal poisoning, but there is no clear evidence to support this assertion • Diagnosis of autism is based on behavioral characteristics- Today still no commonly accepted, biological marker associated with autism • No medical test to diagnose autism • After chelation therapy still no biological marker we can use to see if there has been significant improvement in the child’s degree of autism • Use hair analysis which is not yet accepted by the mainstream community for this application Freeman, S. K. (2007). The complete guide to autism treatments: A parent’s handbook. Lynden, WA: SKF Books.

  45. Any Evidence? • Is there scientific data published in peer-reviewed journals to suggest that chelation therapy is an effective treatment for autism? • No controlled studies with outcome data regarding the effectiveness of chelation in improving symptoms of autism • Claim that chelation can extract metals and repair possible damage to the brain has no supporting evidence in children with autism • There is much anecdotal support in the form of parental report. Freeman, S. K. (2007). The complete guide to autism treatments: A parent’s handbook. Lynden,WA: SKF Books.

  46. Future Research? • Strangle et al. (2007) demonstrated that it would be unethical to test effects of chelation on children in clinical studies due to the potential health risks associated with the drugs.

  47. CONTROVERSIAL CONTROVERSIAL CONTROVERSIAL What part of using chelation in the treatment for autism is NOT experimental? From the experimental testing to the unproven high body burden of chelable metals to the unapproved treatment to the lack of clinical trials. THERE IS NOT ONE EVIDENCE-BASED LEG TO STAND ON! DO NO HARM! NOT ONLY DOES IT LACK SCIENTIFICALLY SOUND EVIDENCE, BUT IT IS A HARMFUL AND POTENTIALLY FATAL EXPERIMENT TO DO ON A CHILD!

  48. PSEUDOSCIENCE? • Promoters benefit financially or otherwise from adoption of the therapy. Authors of the studies and those with websites touting parent testimonials are the same professionals who are directly benefitting from the use of chelation therapy to treat autism. • Catchy, emotionally appealing slogans are used in marketing the therapy. The two largest organizations that are promoting biomedical interventions, including metal detoxification/chelation therapy have as part of their slogans, “Autism is Reversible” (Generation Rescue) and “Autism is Treatable” (Autism Research Institute). The word, “recovery” is often used on both website. • Promoters resist objective evaluation and scrutiny of the therapy by others. Maintain that their findings are accurate despite other studies showing contradictory evidence. • Testimonials, anecdotes, or personal accounts are offered in support of claims about the therapy's effectiveness, but little or no objective evidence is provided. These websites are chockful of parent testimonials. Much credence is put on the Autism Research Institute’s “Parent Ratings of Behavior Effects of Biomedical Interventions” that report chelation therapy scores the highest (74%) for reports of children who “got better” and a low 3% of parent’s reporting that children “got worse.” Retrieved from www.autism.com • Negative findings from scientific studies are ignored or dismissed. Despite evidence that contradicts theory, continue to argue that the theory is supported by scientific evidence.

  49. PSEUDOSCIENCE? • Critics and scientific investigators are often met with hostility, and are accused of persecuting the promoters, being "close-minded," or having some ulterior motive for "debunking" the therapy. Argue there is a cover-up by the CDC and Big Pharm to prove their theory as unsubstantiated. • Rapid effects are promised. Claim in the “studies” is that children improve with only a few rounds- in 1 study 1 round was sufficient! That is a total of 3 days! Wow, that WAS easy! • The "theory" behind the therapy contradicts objective knowledge (and sometimes, common sense). Autism has not been shown to be a disease that can be tested medically. Yes, it may comorbidly exist with many other medical ailments, but it itself is not diagnosed medically. Treating the disorder by medical means contradicts all that we know about autism and its diagnosis. • The therapy is said to be easy to administer, requiring little training or expertise. There are many parents at home chelating their child with autism. • High "success" rates are claimed. Many children are being cured of autism by chelation therapy. Almost all in the study by Adams et al. (2009) showed improvement after just 1 round of DMSA according to the authors. • Use uncoventional ways to measure. Blood test won’t show these metals- do a hair test or “provoke” the toxins out

  50. PSEUDOSCIENCE? • Professionals or other people recommend them. Majority, if not all, of the people claiming that children with autism have a toxic metal body burden are the same people who are extolling the benefits of chelation. Who are these people? DOCTORS, one of the most historically trusted professions! If they are saying it, it has to be true!

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