Kenneth Sokolski

Kenneth Sokolski, M.D. is a psychiatrist practicing in Orange County, California and Associate Adjunct Professor in the Department of Psychiatry and Human behavior at VA Medical Center Long Beach, California.[1]

Education and career

Sokolski attended the University of California, Irvine, where he received his M.D. in 1987 and completed residency in Psychiatry and Human Behavior in 1991.[2][3] He currently works in private practice as a psychiatrist, but continues to be associated with UCI mentoring medical students and residents at the Veterans Affairs Medical Center of Long beach. Dr. Sokolski has published or co-authored numerous articles on the psychopharmacology of various mental illnesses, such as bipolar disorder, schizophrenia, and autism.[4][5][6]

Secretin Study

Of his many publications, one study has ignited profound fascination and controversy in books, newspapers and media.[7][8] Karoly Horvath (University of Maryland) along with Sokolski, et al. coauthored “Improved Social and Language skills after Secretin Administration in Patients with Autism Spectrum disorders” in 1998.[9] This seminal paper proposed that secretin was an effective treatment for autism. Secretin is a 27 amino acid polypeptide hormone secreted by the mucosa of the duodenum, and aids in the regulation the pH and numerous processes in the stomach. The Food and Drug Administration (FDA) approved secretin only for single-dose use in the diagnosis of certain gastrointestinal disorders.[10]

Secretin rise to prominence as a cure for autism stems from the efforts of Victoria Beck and her autistic son, Parker Beck. In April 1996 Victoria took her son Parker (then age 3) to see a gastrointestinal specialist, Dr. Karoly Horvath of the University of Maryland Medical Center due to chronic diarrhea and constipation which began at when he was about six months.[11] Medical condition such as gastrointestinal issues and seizure disorder are strongly associated with in Autistic children.[12][13] Horvath sedated Parker, conducted an upper gastrointestinal endoscopy, and administered secretin intravenously (2 Cu/kg) as part of his standard diagnostic procedure. In the following days, Beck noticed a dramatic reduction in her son’s symptoms. Parker’s digestive difficulties improved, he began sleeping through the night, and begin speaking, although he had been virtually mute before.[14]

Three months later Parker progress stalled, panicked Beck contacted the Autism Research Institute in San Diego founder, Bernard Rimland.[15][16] Rimland’s influence changed the prevailing viewpoint of autism from an emotional illness to a neurodevelopmental disorder, but was controversial due to his support of the MMR vaccine (thiomersal)- Autism link and secretin therapy.[17][18] Through Autism Research Institute, Kenneth Sokolski (then assistant clinical professor at UC Irvine) volunteered to help Victoria Beck after watching home videos of Parker remarkable improvement, and convinced a gastroenterologist to give secretin to his son Aaron (then age 7). Prior to secretin, “you couldn’t get him to look at you at all,” say Dr. Sokolski. After the dose, “he looked right in his therapist eyes.” Dr. Horvath, Sokolski, et al. published a paper on the results with Parker, Aaron Sokolski and another autistic child, in the Journal of the Association for Academic Minority Physicians.

Dr. Sokolski told the Wall Street Journal, “Aaron started regressing five weeks after the initial dose, and subsequent infusion have proved largely disappointing… There is a real effect. It is not our imagination. But it isn’t a magic cure for autism”.[19] Mrs. Beck too noted that her son Parker regressed after about 5 weeks. Other IV infusion was performed 9 months after the first infusion, a third infusion 3 months after the second infusion. However, word of the secretin benefits quickly spread after Mrs. Beck appeared on the television program Dateline NBC on October 7, 1998, followed by a Good Morning America segment the next day.[20] Jane Pauley from Dateline NBC television show called secretin therapy “a development some hail a breakthrough that may literally break the silence of autism”.[21] These and other testimonials sparked a huge demand for off-label secretin use. Multiple Web sites started advertising secretin infusion at great cost.[22] Alarmed by the claims of several thousand recipients of secretin for autism, numerous NIH supported clinical trials were conducted at the University of Washington, University of Colorado, the Universities of Chicago, Utah, Pittsburg, Pennsylvania, California at Irvine, and Harvard University.

The first formal report of the results of a controlled study of the use of secretin with autistic children appeared in the December 9, 1999 issue of the New England Journal of Medicine. Led Researcher, Adrian Sandler gave the article a title that expresses their findings “Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder”.[23] Researchers found no statistically significant differences between secretin and placebo groups. Sokoloski colleague, Bernard Rimland was skeptical of the shortcomings of the study and wrote in Autism Research review “there are at least 13 or 14 other studies of secretin in the pipeline that I know of. This is just the first half of the first inning. …. The bottom line: secretin is here to stay. Don’t let the naysayers discourage you”! [24]

Other researchers soon replicated equally similar negative results in different journals. A literature search of PubMed identified 15 randomized controlled trials (RCTs) examining the efficacy of secretin versus placebo published from 1999 and 2003. Investigators addressed different concerns and criticisms: 9 studies used porcine secretin,[25][26][27][28][29] 5 examined the human synthetic form,[30][31][32] 9 studies used cross-over designs,[33][34][35] multiple doses were given in 2.[36][37] These study consisted of various population size, age range, study length, and Autism diagnosis testing procedures.[38][39] Regardless of the trial methodology, Secretin was no more effective than placebo in treating children with autism, including improving social skills, communication, behavior or global function.[40][41]

References

  1. "Our Doctors". U.S. Department of Veterans Affairs. Retrieved 23 June 2014.
  2. "DCA BreEZe Online Services". California Department of Consumer Affairs. Retrieved 23 June 2014.
  3. "Dr. Kenneth sokolski". Retrieved 23 June 2014.
  4. "Adjunctive quetiapine in bipolar patients partially responsive to lithium or valproate". Prog Neuropsychopharmacol Biol Psychiatry 27: 863–6. Aug 2003. doi:10.1016/S0278-5846(03)00145-3. PMID 12921920.
  5. "Combination loxapine and aripiprazole for refractory hallucinations in schizophrenia". Ann Pharmacother 45: e36. Jul 2011. doi:10.1345/aph.1Q088. PMID 21672885.
  6. "Selective serotonin reuptake inhibitor-related extrapyramidal symptoms in autistic children: a case series". J Child Adolesc Psychopharmacol (J Child Adolesc Psychopharmacology) 14: 143–7. 2004. doi:10.1089/104454604773840599. PMID 15142402.
  7. Maugh, Thomas (December 9, 1999). "In Clinical Trial, Hormone Shows No Effect on Autism". LA Times.
  8. Szabo, Liz. "Research: Autism treatments fall short". USA today.
  9. Horvath, Stefanatos, Sokolski (1998). "Improved social and language skills after secretin administration in patients with autistic spectrum disorders". J Assoc Acad Minor Phys 9 (1): 9–15. PMID 9585670.
  10. Stilwell, Victoria. "Repligen: FDA wants more trials for secretin drug". MarketWatch.
  11. Offit, Paul. Autism's False Prophets: Bad Science, Risky Medicine, and the Search for a Cure. Columbia University Press. ISBN 023114637X.
  12. Rapin, I (Jul 10, 1997). "Autism". N Engl J Med 337 (2): 97–104. doi:10.1056/NEJM199707103370206. PMID 9211680.
  13. Volkmar; et al. Handbook of autism and pervasive developmental disorder (3rd ed.). Wiley. ISBN 0471716987.
  14. Victoria Beck, Bernard Rimland. "Method of using secretin for treating autism". US patents.
  15. Rimland, Bernard (1998). "The Autism-Secretin connection" (PDF). Autism Research Review International 12 (3): 3.
  16. Beck, Victoria. Unlocking the potential of secretin. Autism Research International.
  17. Rimland, Bernard. Infantile Autism: The Syndrome and Its Implications for a Neural Theory of Behavior. Appleton-Century-Crofts.
  18. Miller, Niel. Vaccines, Autism and Childhood Disorders: Crucial Data That Could Save Your Child's Life. New Atlantean Press. ISBN 1881217329.
  19. Johannes, Laura. "New Hampshire Mother Overrode Doubts on New Use of Old Drug". Wall Street Journal.
  20. Bunk, Steve. "Secretin Trials: A drug that might help, or hurt, autistic children is widely prescribed but is just now being tested". The Scientist.
  21. Pauley, Jane (October 7, 1998). "Dateline NBC".
  22. Rimland (1999). "Secretin update: good news about effects, bad news about supply" (PDF). Autism Research Review International 13 (3): 2.
  23. Sandler, Adrian (December 9, 1999). "Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder". N Engl J Med 341 (24): 1801–1806. doi:10.1056/NEJM199912093412404. PMID 10588965.
  24. Rimland, Bernard (December 1999). "Secretin: positive, negative reports in the "top of the first inning"" (PDF). Autism Research Review International: 7.
  25. Chez, MG (April 30, 2000). "Secretin and autism: a two-part clinical investigation". J Autism Dev Disord 30 (2): 87–94. doi:10.1023/A:1005443119324. PMID 10832772.
  26. Coniglio, SJ (May 2001). "A randomized, double-blind, placebo-controlled trial of single-dose intravenous secretin as treatment for children with autism". J Pediatr 138 (5): 649–55. doi:10.1067/mpd.2001.112474. PMID 11343038.
  27. Corbett, B (Jun 2001). "A double-blind, placebo-controlled crossover study investigating the effect of porcine secretin in children with autism". Clin Pediatr (Phila) 40 (6): 327–31. doi:10.1177/000992280104000604. PMID 11824175.
  28. Dunn-Geier, J (Dec 2000). "Effect of secretin on children with autism: a randomized controlled trial". Dev Med Child Neurol 42: 796–802. doi:10.1017/s0012162200001481. PMID 11132252.
  29. Owley, T (Nov 2001). "Multisite, double-blind, placebo-controlled trial of porcine secretin in autism". J Am Acad Child Adolesc Psychiatry 40 (11): 1293–9. doi:10.1097/00004583-200111000-00009. PMID 11699803.
  30. Carey, T (Jun 2002). "Double-blind placebo-controlled trial of secretin: effects on aberrant behavior in children with autism". J Autism Dev Disord 32 (3): 161–7. doi:10.1023/A:1015493412224. PMID 12108617.
  31. Levy, SE (Aug 2003). "Children with autistic spectrum disorders. I: comparison of placebo and single dose of human synthetic secretin". Arch Dis Child 88 (8): 731–6. doi:10.1136/adc.88.8.731. PMID 12876177.
  32. Molly, Cynthia (December 2002). "Lack of benefit of Intravenous Synthetic Human Secretin in the treatment of Autism" (PDF). Journal of Autism and Develop Dis: 545–552.
  33. Unis, Alan (November 2002). "A randomized, Double-blind, placebo- controlled trial of porcine versus synthetic secretin for reducing symptoms of autism" (PDF). J AM Acad Child Adolesc Psychiatry: 1–7.
  34. Kern, JK (Jan 2002). "Efficacy of porcine secretin in children with autism and pervasive developmental disorder". J Autism Dev Disord 32 (3): 153–60. doi:10.1023/A:1015441428154. PMID 12108616.
  35. Owley, Thomas (1999). "A Double-Blind, Placebo-Controlled Trial of Secretin for the Treatment of Autistic Disorder". Medscape General Medicine: www.medscape.com/viewarticle/715516_1.
  36. Roberts, W (May 2001). "Repeated doses of porcine secretin in the treatment of autism: a randomized, placebo-controlled trial" (PDF). Pediatrics.
  37. Sponheim, E (May 2002). "Multiple doses of secretin in the treatment of autism: a controlled study". Acta Paediatrica 91 (5): 540–545. doi:10.1111/j.1651-2227.2002.tb03274.x.
  38. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision. ISBN 0890420254.
  39. Schopler, E (1998). The childhood autism rating scale (CARS). Western Psychological Services.
  40. Yang, Sarah (December 8, 1999). "Hormone secretin may not help autistic children". CNN.
  41. Freeman, David (March 28, 2012). "Autism therapies: Study shows what works, what doesn't". CBS News.
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