Guest guest Posted January 6, 2009 Report Share Posted January 6, 2009 ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe New England Journal of Medicine has just published an article [Abstractbelow] promoting the expanded use of antidepressants for treating looselydefined "Childhood anxiety." All the psychiatrists who authored the study have financial ties to drugmanufacturers. They promote a failed paradigm of care that relies onpsychopharmacology--even as the evidence, contained in company documentsthat were uncovered during litigation--shows that the drugs they recommendpose serious harm for children. Indeed, the drug used in the study, Pfizer's Zoloft, carries a Black Boxsuicide warning on its label. The lead author, JOHN WALKUP, MD, is an Associate Professor of Psychiatry,Director, Division of Child and Adolescent Psychiatry at Johns Hopkins. He receives grants, research support and honoraria from SmithKline Beechamand Solvay Pharmaceuticals, Eli Lilly and Wyeth Pharmaceuticals. He has served as a consultant for Solvay Pharmaceuticals and JanssenPharmaceutica. He has also received honorarium from Pfizer Inc. http://www.mhsource.com/online/walkped/fac.htmlhttp://www.aacap.org/cs/2009_lifelong_learning_institute/faculty Consultant: Eli Lilly, Cephalon, Jazz Pharmaceuticals, Pfizer.Grants: Abbott Laboratories, Eli Lilly, Pfizer.Speaker's Bureau: Cephalon, Eli Lilly, Pfizer.http://www.softconference.com/AACAP/slist.asp?C=1276 BORIS BRIMAHER, MD, , Director, Child and Adolescent Anxiety ProgramCo-Director, Child and Adolescent Bipolar Services Western PsychiatricInstitute and Clinic University of Pittsburgh Medical Center, tellsreporters he receives no industry funds. But has received Honoraria for participating in forums financed by: Abcomm,Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Honoraria & Travel Expenses: American Academy of Child and AdolescentPsychiatry http://www.aacap.org/cs/2009_lifelong_learning_institute/faculty Dr. Birmaher is listed as a co-author of the discredited GlaxoSmithKlinepediatric Paxil study #329 published in the Journal of the American Academyof Child & Adolescent Psychiatry (AACAP). That report prompted New YorkState Attorney General to sue GSK for fraud.He was a co-author of two highly controversial pharmacological treatmentguidelines for children and adolescents recommending increased use of toxicpsychotropic drugs: The 2005 AACAP Guidelines for Children and AdolescentsWith Bipolar Disorder; and the 2007 Texas Children's Medication AlgorithmProject--a drug industry scheme by which taxpayer money is diverted forineffective, dangerous and extremely expensive psychotropic drugs.JOHN MARCH, MD, Director, Program in Child and Adolescent Anxiety, DukeUniversity Medical Center, receives research support from Pfizer, Solvay,Eli Lilly, and Wyeth. He is Speaker for and/or consultant to: Solvay,Pfizer, GlaxoSmithKline, Wyeth, Novartis, and Shire. See: Current Psychiatry Vol. 2, No. 11 / November 2003http://www.currentpsychiatry.com/2003_11/1103_ocd.aspJAMES McCRACKEN, MD, UCLA Neuropsychiatric Institute and Hospital.He receives Contract Research Support from: Aspect Pharmaceuticals,Bristol-Myers Squibb, Eli Lilly. He also receives Consultation Fees from: Pfizer, Sanofi-Aventis, Wyeth.MOIRA RYNN, MD, Columbia University Child and Adolescent PsychiatryConsultant: Pfizer, Inc., Wyeth Research Support: AstraZeneca, Forest Laboratories, Neuropharm, Pfizer,Wyeth Speaker's Bureau: Pfizer, Wyeth.http://www.aacap.org/cs/expert_interviews/disclosures Dr. Rynn has authored articles promoting the use of tricyclicantidepressants and atypical antipsychotics for off-label uses such aspain/anxiety.BRUCE WASLICK MD, Columbia University / NY Psychiatric Institute, Div. Childand Adolescent Psychiatry. Dr. Waslick receives grant/research support from Eli Lilly and Johnson & Johnson.http://mcpap.typepad.com/mcpap_child_psychiatry_in3rd_annual_conf_on_child_psychiatry_in_primary_care.doc Contact: Vera Hassner Sharavveracare212-595-8974http://content.nejm.org/cgi/content/short/359/26/2753New England Journal of Medicine Volume 359:2753-2766 December 25, 2008Cognitive Behavioral Therapy, Sertraline, or a Combination in ChildhoodAnxietyJohn T. Walkup, M.D., Anne Marie Albano, Ph.D., John Piacentini, Ph.D.,Boris Birmaher, M.D., Scott N. Compton, Ph.D., Joel T. Sherrill, Ph.D.,Golda S. Ginsburg, Ph.D., Moira A. Rynn, M.D., James McCracken, M.D., BruceWaslick, M.D., Satish Iyengar, Ph.D., John S. March, M.D., M.P.H., andPhilip C. Kendall, Ph.D. ABSTRACTBackground Anxiety disorders are common psychiatric conditions affectingchildren and adolescents. Although cognitive behavioral therapy andselective serotonin-reuptake inhibitors have shown efficacy in treatingthese disorders, little is known about their relative or combined efficacy.Methods In this randomized, controlled trial, we assigned 488 childrenbetween the ages of 7 and 17 years who had a primary diagnosis of separationanxiety disorder, generalized anxiety disorder, or social phobia to receive14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to200 mg per day), a combination of sertraline and cognitive behavioraltherapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administeredcategorical and dimensional ratings of anxiety severity and impairment atbaseline and at weeks 4, 8, and 12.Results The percentages of children who were rated as very much or muchimproved on the Clinician Global Impression-Improvement scale were 80.7% forcombination therapy (P<0.001), 59.7% for cognitive behavioral therapy(P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superiorto placebo (23.7%). Combination therapy was superior to both monotherapies(P<0.001). Results on the Pediatric Anxiety Rating Scale documented asimilar magnitude and pattern of response; combination therapy had a greaterresponse than cognitive behavioral therapy, which was equivalent tosertraline, and all therapies were superior to placebo. Adverse events,including suicidal and homicidal ideation, were no more frequent in thesertraline group than in the placebo group. No child attempted suicide.There was less insomnia, fatigue, sedation, and restlessness associated withcognitive behavioral therapy than with sertraline.Conclusions Both cognitive behavioral therapy and sertraline reduced theseverity of anxiety in children with anxiety disorders; a combination of thetwo therapies had a superior response rate. (ClinicalTrials.gov number,NCT00052078 [ClinicalTrials.gov] .)Source Information From the Johns Hopkins Medical Institutions, Baltimore (J.T.W., G.S.G.); New York State Psychiatric Institute-Columbia University Medical Center, NewYork (A.M.A., M.A.R.); the University of California at Los Angeles, LosAngeles (J.P., J.M.); Western Psychiatric Institute and Clinic-University ofPittsburgh Medical Center, Pittsburgh (B.B., S.I.); Duke University MedicalCenter, Durham, NC (S.N.C., J.S.M.); the Division of Services andIntervention Research, National Institute of Mental Health, Bethesda, MD(J.T.S.); Baystate Medical Center, Springfield, MA (B.W.); and TempleUniversity, Philadelphia (P.C.K.).This article (10.1056/NEJMoa0804633) was published at www.nejm.org onOctober 30, 2008. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. Quote Link to comment Share on other sites More sharing options...
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