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Old 08-12-2008, 04:13 PM   #1
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Default NJ Legislator: Probe Antipsychotics, Kids&Medical

from http://psychrights.org/Kids/080225Ph...otics2Kids.htm
Product 2000 2001 2002 2003 2004 2005 2006 2007
Abilify $0 $0 $0 $309,257 $1,420,414 $3,081,174 $4,984,463 $6,115,322
Geodon $0 $41,565 $129,088 $212,560 $295,085 $390,794 $437,207 $397,331
Haldol $6,655 $8,558 $13,311 $18,172 $17,206 $13,764 $8,113 $9,448
Risperdal $1,954,461 $3,259,323 $4,022,473 $4,885,024 $4,986,423 $5,419,384 $5,797,825 $5,522,290
Seroquel $150,717 $422,674 $905,333 $1,556,533 $1,882,016 $2,375,059 $2,732,248 $3,011,707
Thorazine $36,905 $41,403 $36,226 $26,881 $14,458 $14,027 $15,009 $18,100
Zyprexa $751,867 $1,270,683 $1,504,897 $1,719,372 $1,594,270 $1,282,623 $1,271,629 $1,107,777

New Jersey’s Medicaid program spent more than $73 million on antipsychotic medications for children less than 18 years old between 2000 and 2007, according to state records, even though the drugs weren’t approved by the FDA for treating kids. And a state official acknowledges the drugs may have been prescribed for conditions other than schizophrenia and bipolar disorder, the approved uses. As a result, a state legislator is calling for an investigation and is formulating legislation.

“There are horror stories about these meds and there’s a reason they’re not prescribed for kids,” says New Jersey assemblyman Pat Diegnan, who adds that he plans to draft a bill to change the practice and to hold talks with the New Jersey attorney general’s office, which recently formed a task force to examine interactions between pharma and docs. “The entire issue is frightening and the state should be taking a closer look at this. I’m concerned about the casual prescribing by doctors and the enormous amount of money being spent.”

The disclosure comes amid growing debate over antipsychotics. At issue are fears that children are misdiagnosed; drugs are inadequately studied; some docs presribe the pills too readily, and drugmakers promote the meds improperly. As reported previously, a growing number of states are suing various drugmakers over marketing that led Medicaid programs to pay unnecessarily for the meds.

Florida, for instance, is reviewing whether antipsychotics were prescribed improperly for ADHD. “There are no studies that have shown they (atypicals) are safe, or for that matter, that they are effective for children,” Ronald Brown, a Temple University pediatric psychology professor who headed an American Psychological Association committee that examined the issue, told The St. Petersburg Times last year. “The bottom line is that the use of psychiatric medications far exceeds the evidence of safety and effectiveness.”

In their defense, New Jersey Medicaid officials say payments are made for any drug that is approved by the FDA, regardless of whether off-label usage is involved. “We don’t practice medicine and we don’t second guess prescribers,” says Kaye Morrow, assistant director for Medicaid in the Department of Health’s division of medical assistance and health services. “If there’s an FDA approval for a drug and there’s no restriction on a drug, we pay for it.”

However, she adds that usage will be examined and data is being gathered by an outside contractor, Comprehensive NeuroScience, a consulting firm that helps states manage their drug costs. The practice, however, is controversial because Lilly, which markets Zyprexa, provides funding that pays for the firm’s services. Such arrangements have been criticized elsewhere, because the drugmaker will monitor ’sloppy prescribing’ by docs, but only if a state agrees to let docs prescribe Zyprexa without first seeking permission from the state. A NJ health department spokeswoman maintains the state avoids this problem because its Medicaid program doesn’t have a formulary and, therefore, a mechanism isn’t in place to influence docs and their prescribing habits.

Meanwhile, though, the FDA has begun approving antipsychotics for youngsters of certain ages. Last summer, Johnson & Johnson’s Risperdal was approved for schizophrenia in teenagers and bipolar disorder in children ages 10 to 17. Last fall, Bristol-Myers Squibb’s Abilify was also approved for teenagers and Lilly’s Zyprexa is being reviewed by the FDA for similar usage.
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Old 08-12-2008, 04:14 PM   #2
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Angry 4000 kids under 10 on mood drugs


UNPUBLISHED figures show that nearly 4000 children under the age of 10 were prescribed anti-depressants last financial year, including 553 children under five and 48 babies.

The commonwealth Department of Health statistics give an alarming, although most likely conservative, age-by-age breakdown of the national use of anti-depressants.

Leading pediatricians and psychiatrists can offer no reason why infants would be given the drugs.

Depression expert Gordon Parker said the numbers were "beyond comprehension" and urged the federal Government to ask doctors responsible for supplying scripts for young children to justify their actions.

Professor Parker, the executive director of the Black Dog Institute, said: "At first pass it is beyond comprehension that more than 500 Australian children - aged one to five years - have received an anti-depressant 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 figures are based on Pharmaceutical Benefits Schedule data that covers only people who received a subsidised prescription. Most anti-depressants are sold privately.

Asked what circumstances might lead to a baby being treated with an anti-depressant drug, the spokesman for the pediatric division of the Royal Australian College of Physicians, John Wray said: "None that come to mind. 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 said the Government would be "very concerned if anti-depressant medications were being inappropriately prescribed and dispensed, particularly to children".

The Therapeutic Goods Administration said in a statement last night that it was powerless to regulate the use of off-label medicines as it was not illegal for doctors to prescribe drugs for non-approved indications. But it said there might be medical practice and medico-legal implications associated with prescribing a medication outside its approved indications.

The 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.

There are numerous examples in the Health Department figures that show doctors are ignoring the warnings.

The anti-depressant drug Venlafaxine, which is marketed here as Effexor by Wyeth Australia, carries a clear statement that reads: "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."

Despite this, 3347 children and teenagers were prescribed the drug last financial year. Eight of those were babies, 19 were aged two and three and another 15 were five years old. A spokeswoman for Wyeth said 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. No anti-depressant is approved in Australia for the treatment of depression in children and adolescents.

Two SSRI anti-depressants have Therapeutic Goods Administration approval to treat children as young as six years for Obsessive Compulsive Disorder; other, older-style anti-depressants can be prescribed by doctors to treat bed-wetting. But even allowing for these conditions, Royal Australian College of Psychiatrists spokesman Peter Jenkins said 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 drug manufacturers around the world being forced to include a warning in their product information, 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 US Food and Drug Administration.

According to the Health Department figures, the most commonly prescribed anti-depressant 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.

The Australian revealed recently that the TGA was investigating the adverse effects of SSRIs, the most widely prescribed group of anti-depressants that includes the well-known brands Prozac and Zoloft.
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Old 08-12-2008, 04:19 PM   #3
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Default Use of SSRIs in Children and Adolescents

CNS Response Provides Poster Review Regarding the Use of SSRIs in Children and Adolescents

November 12, 2008: 10:00 AM EST

CNS 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 rEEG®-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."
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antipsychotics, drugging kids, fda

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