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Fwd: A Failed Paradigm of Care That Induces 1-3 Chronic Medical Conditions

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe evidence is mounting against psychiatry's paradigm of care-in particularits reliance on toxic drugs which, evidence shows, are unsuited for humanconsumption--inasmuch as the prescribed treatments trigger irreversibledisabling measurable biological diseases.Psychiatry's wanton prescribing practices, influenced by pharmaceuticalindustry kick-backs, have been documented.http://ahrp.blogspot.com/2007/03/minnesota-is-first-of-handful-of-states.html As a result, American children have been prescribed antipsychotics-primarilythe new expensive, but highly toxic drugs, called atypical antipsychotics.Indeed, as The New York Times reports, prescriptions have increased morethan fivefold for children over the past decades and a half, "and doctorsnow use them to settle outbursts and aggression in children with a widevariety of diagnoses, despite serious side effects."The latest published analysis of the evidence from the most comprehensivegovernment study of the five second generation neuroleptics /antipsychotics-CATIE-shows that Zyprexa increases the risk of coronary heartdisease [see:http://www.nimh.nih.gov/science-news/2008/certain-antipsychotic-medications-may-increase-risk-for-heart-disease.shtml] The risk of coronary heart disease is but another in a series oflife-threatening diseases induced by Zyprexa.Another study published in the Archives of Pediatric & Adolescent Medicine,examined the medical record of 4140 children and adolescents prescribed 1 of5 atypical or 2 conventional antipsychotics.  The control group was a randomsample of 4500 children not treated with psychotropic medications.The findings confirm the dire risks antipsychotics pose for children:     * Children prescribed an antipsychotic had twice the risk for obesity(OR, 2.13) and triple the risk for type 2 diabetes mellitus (OR, 3.23)compared with the control sample.    * Prevalence of cardiovascular conditions (OR, 2.70) and orthostatichypotension/syncope (OR, 1.64) was also increased in the treatment cohort.      *By the end of the study, 25% of the sample had 1 to 3 comorbidchronic medical conditions --metabolic and cardiovascular DRUG-INDUCEDlife-threatening conditions--in addition to (whatever psychiatric disorder they were originally diagnosedwith).    * Increased risk for metabolic adverse events associated withcombination antipsychotic therapy or concomitant treatment withantidepressants or mood stabilizers was especially evident during the longterm (24 - 36 months).Below the Medscape Medical News Report about the study.The Times reported the findings of another pediatric study--one thatcompared the effects of Eli Lilly's Zyprexa and Janssens' Rispedal inchildren. The findings: "Some of the children in this study gained 15 pounds or more in eight weeks.That's as much as adults gain in a year on these medications. Children areespecially susceptible to these side effects, and this has broadimplications across the board, for the use of these agents to treat anydisorder."Dr. Jon McClellan of the University of Washington, a co-author of the newstudy and of the current guidelines for treating childhood schizophrenia,said in a telephone interview that older schizophrenia drugs should now beconsidered as an alternative in some cases.Those drugs caused irreversible Tardive Dyskinesia (involuntary musclespasms of the face and torso). They were abandoned when the new drugs weretouted as "miracle" improvements.Neither class of drugs are safe or effective.What, we want to know, is what prevents psychiatrists-including Dr.McClellan-from abandoning the failed paradigm of care that merely shuttlesbetween comparably toxic drugs? Why not re-examine non-chemical therapies?    Contact: Vera Hassner Sharavveracare212-595-8974~~~~~~~~~~~~~~~~~~~~~~~~Medscape Medical NewsPediatric Use of Antipsychotics Linked to Metabolic and CardiovascularEvents CME/CENews Author: Laurie Barclay, MDCME Author: Laurie Barclay, MDRelease October 7, 2008; Valid for credit through October 7, 2009Credits AvailablePhysicians - maximum of 0.25 AMA PRA Category 1 Credit(s)T for physicians;Family Physicians - up to 0.25 AAFP Prescribed credit(s) for physicians;Nurses - 0.25 ANCC contact hours (0.25 contact hours are in the area ofpharmacology)All other healthcare professionals completing continuing education creditfor this activity will be issued a certificate of participation.Physicians should only claim credit commensurate with the extent of theirparticipation in the activity.To participate in this internet activity: (1) review the target audience,learning objectives, and author disclosures; (2) study the educationcontent; (3) take the post-test and/or complete the evaluation; (4)view/print certificate View details.~~~~~~~October 7, 2008 - The use of antipsychotics in children and teens mayincrease the risk for adverse metabolic and cardiovascular events, accordingto the results of a retrospective cohort study reported in the October issueof the Archives of Pediatric & Adolescent Medicine."During the past decade, there has been a substantial increase in the use ofantipsychotics, predominantly atypical or second-generation antipsychotics(SGAs), in young persons treated in privately and publicly insured systems,"write Roger S. McIntyre, MD, FRCPC, from the University Health Network inToronto, Ontario, Canada, and Jeanette M. Jerrell, PhD, from the Universityof South Carolina School of Medicine in Columbia. "However, a paucity ofcontrolled studies provide a quantitative estimate of the relative risksassociated with these agents in young populations."The study goal was to examine factors associated with incidentcardiovascular events and metabolic disturbance in children and adolescentstreated with antipsychotic drugs through South Carolina's Medicaid programfrom January 1, 1996, through December 31, 2005. The investigators evaluatedMedicaid medical and pharmacy claims covering outpatient and inpatientmedical services and medication prescriptions.Incidence and prevalence rates for obesity, type 2 diabetes mellitus,dyslipidemia, cardiovascular events, cerebrovascular events, hypertension,and orthostatic hypotension were compared in a treatment cohort of 4140children and adolescents prescribed 1 of 5 atypical or 2 conventionalantipsychotics vs a random sample of 4500 children not treated withpsychotropic medications.Compared with the control sample, the treatment cohort exposed toantipsychotic drugs had a higher prevalence of obesity (odds ratio [OR],2.13), type 2 diabetes mellitus (OR, 3.23), cardiovascular conditions (OR,2.70), and orthostatic hypotension (OR, 1.64).Compared with patients treated with only 1 antipsychotic drug, those exposedto multiple antipsychotics had a significantly greater risk for incidentobesity or weight gain (OR, 2.28), type 2 diabetes mellitus (OR, 2.36), anddyslipidemia (OR, 5.26). Use of conventional (OR, 4.34) or multiple (OR,1.57) antipsychotics and mood stabilizers (OR, 1.31) was linked to a greaterincidence of cardiovascular events. Patients prescribed selective serotoninreuptake inhibitors (OR, 1.77) and mood stabilizers (OR, 1.35) in additionto antipsychotics had a greater prevalence of incident orthostatichypotension.Limitations of this study include data not controlled; use of secondaryadministrative data and observational techniques in a retrospective cohortdesign; some of the medication exposure groups including less than 5% of thecohort (ie, conventional antipsychotics, aripiprazole, and ziprasidone),limiting power; lack of structured research and clinical interviews toconfirm any of the assigned medical disorders; underestimation of adverseevents on the basis of spontaneous reporting to a clinician; inability todetermine causality; key risk factors such as family history of obesity,metabolic disorders, and cardiovascular disorders not available in thedatabase; truncated availability of ziprasidone and aripiprazole during thestudy period, possibly limiting the incidence of adverse events attributableto these drugs; and inability to estimate how representative this Medicaidcohort is in relationship to those in other states and service systems."Antipsychotics are associated with several metabolic andcardiovascular-related adverse events in pediatric populations, especiallywhen multiple antipsychotics or classes of psychotropic medications arecoprescribed, controlling for individual risk factors," the study authorswrite. "When evaluating the overall benefit-risk ratio of antipsychotics inchildren and adolescents, the practitioner needs to give carefulconsideration to possible metabolic disruptions or cardiovascular toxiceffects, especially in individuals with comorbid metabolic conditions andthose receiving concomitant psychotropic medications."The State Mental Health Data Infrastructure supported this study. Dr. McIntyre has disclosed various financial relationships with Eli Lilly,the Stanley Medical Research Institute, the National Alliance for Researchon Schizophrenia and Depression, AstraZeneca, Biovail, Bristol-Myers Squibb,France Foundation, GlaxoSmithKline, Janssen-Ortho, Organon, Lundbeck,Pfizer, Solvay/Wyeth, Shire, Physicians' Postgraduate Press, and 13CME.Arch Pediatr Adolesc Med. 2008;162:929-935.~~~~~~~~~~http://www.nytimes.com/2008/09/15/health/research/15drug.html THE NEW YORK TIMESRisks found for youths in new antipsychoticsBy BENEDICT CAREYOct.17, 2008A new government study published Monday has found that the medicines mostoften prescribed for schizophrenia in children and adolescents are no moreeffective than older, less expensive drugs and are more likely to cause someharmful side effects. The standards for treating the disorder should bechanged to include some older medications that have fallen out of use, thestudy's authors said.The results, being published online by The American Journal of Psychiatry,are likely to alter treatment for an estimated one million children andteenagers with schizophrenia and to intensify a broader controversy in childpsychiatry over the newer medications, experts said.Prescription rates for the newer drugs, called atypical antipsychotics, haveincreased more than fivefold for children over the past decades and a half,and doctors now use them to settle outbursts and aggression in children witha wide variety of diagnoses, despite serious side effects.A consortium of state Medicaid directors is currently evaluating the use ofthese drugs in children on state Medicaid rolls, to ensure they are beingprescribed properly.The study compared two of the newer antipsychotics, Zyprexa from Eli Lillyand Risperdal from Janssen, with an older medication and found that allthree relieved symptoms of schizophrenia, like auditory hallucinations, inmany young patients. Yet half of the children in the study stopped takingtheir drug within two months, either because it had no effect or was causingserious side effects, like rapid weight gain. The children receiving Zyprexagained so much weight that a government oversight panel monitoring safetyordered that they be taken off the drug.The long-anticipated study, financed by the National Institute of MentalHealth, is the most rigorous, head-to-head trial of the drugs in childrenand adolescents with this disorder. About three million Americans sufferfrom schizophrenia, and perhaps 40 percent first show symptoms in theirteens or earlier."This is really a landmark study, because these newer drugs have been aroundfor 12 years or so now, and there were fundamental questions for which wereally didn't have answers," said Sanjiv Kumra, director of the division ofchild and adolescent psychiatry at the University of Minnesota, who was notinvolved in the study.Kumra said the results revealed significant differences in the drugs' sideeffects that should help doctors and patients choose among them."What this is saying is that all treatments work, at least for some people,and have serious risks for others," he said. "It's a trial-and-errorprocess" to match people with the right medication.Jon McClellan of the University of Washington, a co-author of the new studyand of the current guidelines for treating childhood schizophrenia, said ina telephone interview that older schizophrenia drugs should now beconsidered as an alternative in some cases."Some of the children in this study gained 15 pounds or more in eightweeks," McClellan said. "That's as much as adults gain in a year on thesemedications. Children are especially susceptible to these side effects, andthis has broad implications across the board, for the use of these agents totreat any disorder."Studies have found that more than 80 percent of prescriptions for atypicalantipsychotics for children are to treat something other than schizophrenia,like autism-related aggression, bipolar disorder or attention-deficitproblems. Some of these are approved uses; others are not.The researchers, led by Linmarie Sikich of the University of North Carolina,recruited 119 young people, ages 8 to 19, who suffer from psychoticsymptoms. The children received either Zyprexa, Risperdal or molindone, anolder drug used to blunt psychosis. Neither the young patients nor thedoctors treating them knew which drug was being taken, but the researcherstold the youngsters and their parents that, if the medication was notworking out, the family could switch to another one.After eight weeks, 34 percent of the children taking Zyprexa, 46 percent ofthose on Risperdal, and 50 percent of those receiving molindone showedsignificant improvement.But by that time so many of the patients had stopped taking the drug theywere on that it was not clear that those differences were significant. Manyhad gained a lot of weight: an average of about nine pounds for those in theRisperdal group, and 13 pounds in the Zyprexa group.Both groups also showed changes in cholesterol and insulin levels that arerisk factors for diabetes. Those taking molindone gained less than a pound,on average, and had little metabolic changes."I thought the extra weight was putting a lot of pressure on me," saidBrandon Constantineau, 18, a study participant in Wilmington, NorthCarolina, who gained 35 pounds while taking Risperdal for several months."Kids at school were making fun of me, all that. I knew I had to get rid ofit. I exercised a lot, but it didn't happen until I changed drugs."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. _____________Infomail1 mailing listto send a message to Infomail1-leave =====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.

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