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The headline news in The Australian reads: 4000 Australian children under 10 prescribed antidepressants, 48 babies. “Experts appalled” “Numbers beyond comprehension”SSRIs have severe adverse effects–including a two to six-fold increased risk of suicide attempts–and that risk is NOT offset by a benefit. CNN reports (below) that based on an analysis of individual biomarkers which predict effectiveness of drugs (“personalized medicine” or Referenced EEG), confirms the evidence from controlled clinical trials–that children and adolescents do not respond positively to SSRI antidepressants:

“One conclusion of this analysis was that, at most, 26 percent of these patients might be expected to sustain a good response to an SSRI. Seventy-four percent would not be expected to be responders, or their response probability would be so low as to question the risk of negative response to the probability of positive response. The poster notes, ‘These results question the rationalization of SSRIs as a first-line treatment without the benefit of some physiologic marker to select the appropriate child or adolescent candidate’.”

If 74% of children who are prescribed SSRIs don’t benefit but are put at increased serious risk of harm, what propels doctors–mostly psychiatrists–other than financial incentives (i.e. kickbacks)–to prescribe SSRI antidepressants for children?

In Australia, no antidepressant is approved for the treatment of depression in children and adolescents.” Even as the validated scientific evidence demonstrates that psychotropic drugs are doing far more harm than good–especially when prescribed for children / adolescents whose developing brains and bodies are damaged by the serious adverse effects of drugs such as the SSRI antidepressants and so-called ‘atypical’ antipsychotics (i.e. neuroleptics) doctors–mostly psychiatrists–in the US and Australia disregard the warnings, disregard the perceptible drug-induced harmful effects for patients.

The Australian Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI anti-depressant drugs to children under 18 – aside from two that are approved for obsessive compulsive disorder in children aged over six years – and points out that the drug companies themselves advise against their use for any condition. But, The Australian reports, “There are numerous examples in the Health Department figures that show doctors are ignoring the warnings.” Australian doctors, it appears, are following the abusive prescribing protocol that irresponsible US psychiatrists follow. Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder:

“At first pass, it is beyond comprehension that more than 500 Australian children – aged one to five years – have received an antidepressant drug. When the particular drugs are considered, the risk of significant side effects – let alone their efficacy – is of key concern. It strikes me that there would be wisdom in having the doctors justify such prescriptions to determine whether there are any justifiable reasons for such surprising data.”

The US and Australian pediatric SSRI drug prescribing data provides evidence for indicting physicians who prescribe these drugs for children of undermining the health of children. The real tragedy is that doctors who are given a government license to prescribe drugs safely for the benefit of patients, are abusing their license. They are prescribing drugs they know (or should know if they read the evidence) cause patients harm. Doctors–not drug companies–are to blame for creating a public health crisis.

CNNCNS Response Provides Poster Review Regarding the Use of SSRIs in Children and AdolescentsNovember 12, 2008CNS Response, Inc. (OTCBB: CNSO) reported today the results of a study presented at the U.S. Psychiatric and Mental Health Congress by Daniel Hoffman, M.D., Chief Medical Officer for CNS Response. The poster presentation, titled “First Do No Harm: Children and SSRIs,” provided an analysis of the utilization of SSRIs (Selective Serotonin Reuptake Inhibitors) as a first-line treatment in children or adolescents without the benefit of a physiologic marker technology, such as CNS Response rEEGR-guided pharmacotherapy. “This is my second poster on how rEEG personalized medicine has helped advance our medical obligation to ‘First Do No Harm,’” commented Dr. Hoffman. “Due to the FDA’s warning of suicide risk, coupled with the popularity of SSRI prescriptions for children and adolescents, we reviewed the CNS Response rEEG database and associated reports, in combination with our own patient data, to look for any trends in this age range that might provide further insights in consideration of these medications.

The results beg for a larger analysis, as the findings give credence to SSRIs not being the drug of choice for some children and adolescents with depression. A system, like rEEG, to better guide appropriate selection of those children and adolescents, would be of great value to all.” Researchers had the benefit of two data sets. The first data set was the rEEG analysis of 65 unmedicated patients and their associated rEEG-guided medication report. The second data set was comprised of 15 patients whose outcomes were known after following the rEEG treatment guidance. Results in the 15 patients were used to estimate probable results, based on stratification of the larger group of 65 patients through their own rEEG response prediction. The rEEG database gives a predictive probability score of medication response delineated by medication class, type and specific drug, where Sensitive has an 80 percent or greater probability, Intermediate has a 35 to 85 percent probability, and Resistant has a < 35 percent probability that patients with this brainwave (QEEG) pattern will have a positive response. One conclusion of this analysis was that, at most, 26 percent of these patients might be expected to sustain a good response to an SSRI. Seventy-four percent would not be expected to be responders, or their response probability would be so low as to question the risk of negative response to the probability of positive response.

The poster notes, “These results question the rationalization of SSRIs as a first-line treatment without the benefit of some physiologic marker to select the appropriate child or adolescent candidate.” “While it is difficult to draw scientific conclusions from this non-statistically sampled review, the low number of cases indicating SSRI responsiveness was noteworthy, given the clinical popularity of those medications,” said CNS Response Chief Executive Officer Len Brandt. “I think this is an example of the utility of rEEG’s ability to extend beyond specific, personalized medication to use as an analytical tool in consideration of medical policy.” The full poster presentation and analysis of results are available at

Australian children under 10 prescribed antidepressants Julie-Anne Davies2 Dec 2008 Unpublished figures show that nearly 4,000 children under the age of 10 were prescribed antidepressants last year, including 553 children under five and 48 babies, even though no antidepressant is approved in Australia for the treatment of depression in children and adolescents, The Australian reports.”At first pass, it is beyond comprehension that more than 500 Australian children – aged one to five years – have received an antidepressant drug,” Gordon Parker, executive director of the Black Dog Institute, a non-profit devoted to education about depression and bipolar disorder, tells the paper.

“When the particular drugs are considered, the risk of significant side effects – let alone their efficacy – is of key concern. It strikes me that there would be wisdom in having the doctors justify such prescriptions to determine whether there are any justifiable reasons for such surprising data.”

The figures are based on Pharmaceutical Benefits Schedule data that covers only people who received a subsidized prescription, according to the paper, which notes that most antidepressants are sold privately. A spokesman for the pediatric division of the Royal Australian College of Physicians was unable to explain the prescribing patterns:

“The college would like to know who is prescribing these drugs to such young children and why.”

Parliamentary Secretary for Health and Ageing Jan McLucas tells the paper that the government would be “very concerned if antidepressant medications were being inappropriately prescribed and dispensed, particularly to children.” And the government’s Therapeutic Goods Administration issued a statement saying it was powerless to regulate the use of off-label med, but maintained there might be medical practice and medico-legal implications associated with prescribing a drug beyond approved indications.

The Adverse Drug Reactions Advisory Committee warns doctors against prescribing any of the SSRI antidepressant drugs to children under 18 -aside from two that are approved for obsessive compulsive disorder in children aged over six years – and points out that drugmakers themselves advise against their use for any condition. There are numerous examples in the Health Department figures that show doctors are ignoring the warnings, according to the paper. Wyeth’s Effexor carries this statement: “Do not give Effexor XR to children or adolescents under 18 years of age. The safety and effectiveness of Effexor XR in this age group have not been established.” Yet, 3,347 children and teenagers were prescribed the drug last financial year. Eight were babies, 19 were aged two and three and another 15 were five years old.

A Wyeth spokeswoman tells the paper the drug was not indicated for use in children and adolescents below 18 years of age, and it had never recommended its use in this population.Two SSRI antidepressants have Therapeutic Goods Administration approval to treat children as young as six years for Obsessive Compulsive Disorder; and other, older antidepressants can be prescribed by doctors to treat bedwetting. But even allowing for these conditions, Royal Australian College of Psychiatrists spokesman Peter Jenkins tells the Australian the figures were mysterious and worrying. The Health Department figures were obtained by the Citizens Commission on Human Rights, a Church of Scientology-backed lobby group opposed to anti-depressant therapy.

The most comprehensive research into SSRI anti-depressants and their use in children and adolescents in 2004 led to drugmakers being forced to include a warning in product labeling, stating the drugs could increase the risk of suicidal thoughts and behaviour in children. This followed the results of an extensive analysis of clinical trial data by the FDA in the US. According to the Health Department figures, the most commonly prescribed antidepressant for children and adolescents aged under 18 years is Prozac, with 7833 given the drug in the past year, including 863 children aged under 10.

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