Fwd: SSRIs Not Recommended for Youth_4, 000 Australian Kids--48 Babies Rx SSRIs

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ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org  and http://ahrp.blogspot.com FYIThe headline news in The Australian reads: 4000 Australian children under 10prescribed antidepressants, 48 babies     * Experts appalled    * Numbers "beyond comprehension"SSRIs have severe adverse effects--including a two to six-fold increasedrisk of suicide attempts--and that risk is NOT offset by a benefit.  CNN reports (below) that based on an analysis of individual biomarkers whichpredict effectiveness of drugs ("personalized medicine" or Referenced EEG),confirms the evidence from controlled clinical trials--that children andadolescents do not respond positively to SSRI antidepressants: "One conclusion of this analysis was that, at most, 26 percent of thesepatients might be expected to sustain a good response to an SSRI.Seventy-four percent would not be expected to be responders, or theirresponse probability would be so low as to question the risk of negativeresponse to the probability of positive response. The poster notes,  'Theseresults question the rationalization of SSRIs as a first-line treatmentwithout the benefit of some physiologic marker to select the appropriatechild or adolescent candidate'." If 74% of children who are prescribed SSRIs don't benefit but are put atincreased serious risk of harm, what propels doctors--mostlypsychiatrists--other than financial incentives (i.e. kickbacks)--toprescribe SSRI antidepressants for children? In Australia, no antidepressantis approved for the treatment of depression in children and adolescents." Even as the validated scientific evidence demonstrates that psychotropicdrugs are doing far more harm than good--especially when prescribed forchildren / adolescents whose developing brains and bodies are damaged by theserious adverse effects of drugs such as the SSRI antidepressants andso-called 'atypical' antipsychotics (i.e. neuroleptics) doctors--mostlypsychiatrists--in the US and Australia disregard the warnings, disregard theperceptible drug-induced harmful effects for patients.The Australian Adverse Drug Reactions Advisory Committee warns doctorsagainst prescribing any of the SSRI anti-depressant drugs to children under18 - aside from two that are approved for obsessive compulsive disorder inchildren aged over six years - and points out that the drug companiesthemselves advise against their use for any condition.  But, The Australian reports, "There are numerous examples in the HealthDepartment figures that show doctors are ignoring the warnings."  Australian doctors, it appears, are following the abusive prescribingprotocol that irresponsible US psychiatrists follow. See:http://psychrights.org/Kids/080225PharmalotNJLegislatorProbeAntipsychotics2Kids.htmGordon Parker, executive director of the Black Dog Institute, a non-profitdevoted to education about depression and bipolar disorder: "At first pass,it is beyond comprehension that more than 500 Australian children - aged oneto five years - have received an antidepressant drug. When the particulardrugs are considered, the risk of significant side effects - let alone theirefficacy - is of key concern. It strikes me that there would be wisdom inhaving the doctors justify such prescriptions to determine whether there areany justifiable reasons for such surprising data." The US and Australian pediatric SSRI drug prescribing data provides evidencefor indicting physicians who prescribe these drugs for children ofundermining the health of children. The real tragedy is that doctors who are given a government license toprescribe drugs safely for the benefit of patients, are abusing theirlicense. They are prescribing drugs they know (or should know if they readthe evidence) cause patients harm. Doctors--not drug companies--are to blamefor creating a public health crisis.   Contact: Vera Hassner Sharavveracare212-595-8974http://money.cnn.com/news/newsfeeds/articles/marketwire/0451591.htm CNNCNS Response Provides Poster Review Regarding the Use of SSRIs in Childrenand AdolescentsNovember 12, 2008CNS Response, Inc. (OTCBB: CNSO) reported today the results of a studypresented at the U.S. Psychiatric and Mental Health Congress by DanielHoffman, M.D., Chief Medical Officer for CNS Response. The posterpresentation, titled "First Do No Harm: Children and SSRIs," provided ananalysis of the utilization of SSRIs (Selective Serotonin ReuptakeInhibitors) as a first-line treatment in children or adolescents without thebenefit of a physiologic marker technology, such as CNS ResponserEEGR-guided pharmacotherapy. "This is my second poster on how rEEG personalized medicine has helpedadvance our medical obligation to 'First Do No Harm,'" commented Dr.Hoffman. "Due to the FDA's warning of suicide risk, coupled with thepopularity of SSRI prescriptions for children and adolescents, we reviewedthe CNS Response rEEG database and associated reports, in combination withour own patient data, to look for any trends in this age range that mightprovide further insights in consideration of these medications. The resultsbeg for a larger analysis, as the findings give credence to SSRIs not beingthe drug of choice for some children and adolescents with depression. Asystem, like rEEG, to better guide appropriate selection of those childrenand adolescents, would be of great value to all." Researchers had the benefit of two data sets. The first data set was therEEG analysis of 65 unmedicated patients and their associated rEEG-guidedmedication report. The second data set was comprised of 15 patients whoseoutcomes were known after following the rEEG treatment guidance. Results in the 15 patients were used to estimate probable results, based onstratification of the larger group of 65 patients through their own rEEGresponse prediction. The rEEG database gives a predictive probability scoreof medication response delineated by medication class, type and specificdrug, where Sensitive has an 80 percent or greater probability, Intermediatehas a 35 to 85 percent probability, and Resistant has a < 35 percentprobability that patients with this brainwave (QEEG) pattern will have apositive response. One conclusion of this analysis was that, at most, 26 percent of thesepatients might be expected to sustain a good response to an SSRI.Seventy-four percent would not be expected to be responders, or theirresponse probability would be so low as to question the risk of negativeresponse to the probability of positive response. The poster notes, "Theseresults question the rationalization of SSRIs as a first-line treatmentwithout the benefit of some physiologic marker to select the appropriatechild or adolescent candidate." "While it is difficult to draw scientific conclusions from thisnon-statistically sampled review, the low number of cases indicating SSRIresponsiveness was noteworthy, given the clinical popularity of thosemedications," said CNS Response Chief Executive Officer Len Brandt. "I thinkthis is an example of the utility of rEEG's ability to extend beyondspecific, personalized medication to use as an analytical tool inconsideration of medical policy." The full poster presentation and analysis of results are available atwww.cnsresponse.com/ssriposterpresentation ============ http://www.theaustralian.news.com.au/story/0,25197,24743413-23289,00.htmlTHE AUSTRALIAN4000 Australian children under 10 prescribed antidepressants Julie-Anne Davies2 Dec 2008     * 4000 kids on antidepressants, 48 babies    * Experts appalled    * Numbers "beyond comprehension"Unpublished figures show that nearly 4,000 children under the age of 10 wereprescribed antidepressants last year, including 553 children under five and48 babies, even though no antidepressant is approved in Australia for thetreatment of depression in children and adolescents, The Australian reports."At first pass, it is beyond comprehension that more than 500 Australianchildren - aged one to five years - have received an antidepressant drug,"Gordon Parker, executive director of the Black Dog Institute, a non-profitdevoted to education about depression and bipolar disorder, tells the paper."When the particular drugs are considered, the risk of significant sideeffects - let alone their efficacy - is of key concern. It strikes me thatthere would be wisdom in having the doctors justify such prescriptions todetermine whether there are any justifiable reasons for such surprisingdata." The figures are based on Pharmaceutical Benefits Schedule data that coversonly people who received a subsidized prescription, according to the paper,which notes that most antidepressants are sold privately. A spokesman forthe pediatric division of the Royal Australian College of Physicians wasunable to explain the prescribing patterns: "The college would like to knowwho is prescribing these drugs to such young children and why." Parliamentary Secretary for Health and Ageing Jan McLucas tells the paperthat the government would be "very concerned if antidepressant medicationswere being inappropriately prescribed and dispensed, particularly tochildren." And the government's Therapeutic Goods Administration issued astatement saying it was powerless to regulate the use of off-label med, butmaintained there might be medical practice and medico-legal implicationsassociated with prescribing a drug beyond approved indications. The Adverse Drug Reactions Advisory Committee warns doctors againstprescribing any of the SSRI antidepressant drugs to children under 18 -aside from two that are approved for obsessive compulsive disorder inchildren aged over six years - and points out that drugmakers themselvesadvise against their use for any condition. There are numerous examples in the Health Department figures that showdoctors are ignoring the warnings, according to the paper. Wyeth's Effexor carries this statement: "Do not give Effexor XR to childrenor adolescents under 18 years of age. The safety and effectiveness ofEffexor XR in this age group have not been established." Yet, 3,347 childrenand teenagers were prescribed the drug last financial year. Eight werebabies, 19 were aged two and three and another 15 were five years old. AWyeth spokeswoman tells the paper the drug was not indicated for use inchildren and adolescents below 18 years of age, and it had never recommendedits use in this population.Two SSRI antidepressants have Therapeutic Goods Administration approval totreat children as young as six years for Obsessive Compulsive Disorder; andother, older antidepressants can be prescribed by doctors to treatbedwetting. But even allowing for these conditions, Royal Australian Collegeof Psychiatrists spokesman Peter Jenkins tells the Australian the figureswere mysterious and worrying. The Health Department figures were obtained by the Citizens Commission onHuman Rights, a Church of Scientology-backed lobby group opposed toanti-depressant therapy. The most comprehensive research into SSRI anti-depressants and their use inchildren and adolescents in 2004 led to drugmakers being forced to include awarning in product labeling, stating the drugs could increase the risk ofsuicidal thoughts and behaviour in children. This followed the results of anextensive analysis of clinical trial data by the FDA in the US. According to the Health Department figures, the most commonly prescribedantidepressant for children and adolescents aged under 18 years is Prozac,with 7833 given the drug in the past year, including 863 children aged under10. Source: The AustralianFAIR 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. 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