via NYTimes:
Use of Antipsychotics in Children Is Criticized
By GARDINER HARRIS
a few excerpts:
"From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal."
"At least 11 of the deaths were children whose treatment with Risperdal was unapproved by the F.D.A. Once the agency approves a medicine for a particular condition, doctors are free to prescribe it for other problems."
"Panel members said they had for years been concerned about the effects of Risperdal and similar medicines, but F.D.A. officials said no studies had been done to test the drugs’ long-term safety."
"Dr. Dure said he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines."
“I have a bias that extra-pyramidal side effects are being under-recognized with these agents,” Dr. Dure said.
"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects." here
via Archives of General Psychiatry:
Original Article | June 2006
National Trends in the Outpatient Treatment of Children and Adolescents With Antipsychotic Drugs
Mark Olfson, MD, MPH; Carlos Blanco, MD, PhD; Linxu Liu, PhD; Carmen Moreno, MD; Gonzalo Laje, MD
an excerpt:
Child and adolescent mental health visits that include antipsychotic treatment occur disproportionately among publicly rather than privately insured patients. After adjusting for patient diagnosis and other background characteristics, mental health visits by publicly insured children and adolescents were significantly more likely to include prescription of an antipsychotic medication. This finding is in line with higher youth antipsychotic prescription utilization among populations covered by Medicaid2 - 3 compared with commercially insured populations.4 The basis of this is unknown but may relate to differences in public and private payer reimbursement schedules for pharmacologic or psychological interventions, insurance-related variations in parent or child acceptance of antipsychotic treatment, or selection of patients in different insurance plans by physicians for treatment. Because Medicaid covers children and adolescents with Social Security Income and young people who are medically needy or in foster care, illness severity may account for differences in antipsychotic medication use across insurance groups.29 Additional study is needed to understand the factors that contribute to insurance-related differences in child and adolescent antipsychotic treatment.
Approximately one third of the child and adolescent visits with prescription of antipsychotic medications were by young people with mood disorders. In addition, approximately one third of antipsychotic visits included coprescription of an antidepressant medication and one third included coprescription of a mood stabilizer. At present, there is a dearth of empirical evidence to support these prescribing patterns.
In office-based practice, almost all of the antipsychotic treatment among children and adolescents is provided by psychiatrists. Although the NAMCS data suggest that primary care physicians and other nonpsychiatrist physicians provide care in approximately half of the youth mental health visits, they seldom prescribe antipsychotic medications. (emphasis mine) here
via American Journal of Psychiatry:
November 01, 2008
Double-Blind Comparison of First- and Second-Generation Antipsychotics in Early-Onset Schizophrenia and Schizo-affective Disorder: Findings From the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) Study
Am J Psychiatry 2008;165:1420-1431. doi: 10.1176/appi.ajp.2008.08050756
a couple of excerpts:
Finally, different choices could have been made with regard to the specific medications studied. At the time the trial was initiated, olanzapine was widely used in the pediatric population, whereas quetiapine had a small market share. Ziprasidone and aripiprazole, both of which may have fewer metabolic side effects, were introduced subsequent to the initiation of the study. Efforts to introduce them partway through the study were not supported by the FDA or NIMH. We also considered utilizing a placebo for comparison, as opposed to a first-generation antipsychotic. We expected that this would increase the demonstrated efficacy of the second-generation antipsychotics, but it would not address the fundamental comparative questions. Distributing the sample among four treatment conditions rather than three would also have reduced statistical power. We also considered requiring a drug-free baseline to minimize the likelihood of finding no apparent benefit of substituting one partially effective treatment for another. However, concerns about the long-term consequences of delaying effective treatment and associated recruitment difficulties argued against including a placebo treatment group or a drug-free baseline. At the time the study was initiated, there were significant ethical concerns about utilizing any first-generation antipsychotic in comparison with second-generation antipsychotics, because second-generation antipsychotic treatment was the standard of care for early-onset schizophrenia and schizoaffective disorder. We felt any traditional medication selected as a comparator would have to provide a strong potential advantage to maintain therapeutic equipoise. Molindone was chosen as the best option among first-generation antipsychotics based on its low propensity for both weight gain and extrapyramidal side effects. Despite this advantage, molindone is not commonly used in clinical practice. A more frequently used medication, such as perphenazine or haloperidol, might have facilitated comparison with adult studies and acceptance in the community. Failure to require a drug-free baseline may have reduced response rates and led to earlier treatment discontinuation.
Finally, different choices could have been made with regard to the specific medications studied. At the time the trial was initiated, olanzapine was widely used in the pediatric population, whereas quetiapine had a small market share. Ziprasidone and aripiprazole, both of which may have fewer metabolic side effects, were introduced subsequent to the initiation of the study. Efforts to introduce them partway through the study were not supported by the FDA or NIMH. We also considered utilizing a placebo for comparison, as opposed to a first-generation antipsychotic. We expected that this would increase the demonstrated efficacy of the second-generation antipsychotics, but it would not address the fundamental comparative questions. Distributing the sample among four treatment conditions rather than three would also have reduced statistical power. We also considered requiring a drug-free baseline to minimize the likelihood of finding no apparent benefit of substituting one partially effective treatment for another. However, concerns about the long-term consequences of delaying effective treatment and associated recruitment difficulties argued against including a placebo treatment group or a drug-free baseline. At the time the study was initiated, there were significant ethical concerns about utilizing any first-generation antipsychotic in comparison with second-generation antipsychotics, because second-generation antipsychotic treatment was the standard of care for early-onset schizophrenia and schizoaffective disorder. We felt any traditional medication selected as a comparator would have to provide a strong potential advantage to maintain therapeutic equipoise. Molindone was chosen as the best option among first-generation antipsychotics based on its low propensity for both weight gain and extrapyramidal side effects. Despite this advantage, molindone is not commonly used in clinical practice. A more frequently used medication, such as perphenazine or haloperidol, might have facilitated comparison with adult studies and acceptance in the community. Failure to require a drug-free baseline may have reduced response rates and led to earlier treatment discontinuation.
Another potential limitation of the study is the 8-week duration of treatment. Different patterns of response or risk of side effects might have emerged over a longer trial. Some young people may require more extended therapy to adequately respond, and it is likely that some aspects of the illness, such as negative symptoms, neurocognitive function, and associated anxiety, may require longer periods to recover (44, 45). However, published standards of care for early-onset schizophrenia and schizoaffective disorder recommend the use of 6- to 8-week trials (1). A longer acute phase trial would have increased the risk of exposing subjects to prolonged ineffective treatment. Furthermore, antipsychotic medication trials in adults with schizophrenia suggest that nonresponse as early as 2–4 weeks after initiating treatment predicts nonresponse up to 12 weeks later (46–49).
The results question the nearly exclusive use of second-generation antipsychotics to treat early-onset schizophrenia and schizoaffective disorder. The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders. here
Let's be real, using neuroleptic drugs for any psychiatric diagnosis is not supported by any definitive evidence; calling the drugs "effective treatment" is more than stretching the truth---Indeed, the evidence clearly demonstrates neuroleptic drugs are minimally effective for a small minority of children and adults experiencing symptoms of psychosis; and have significant disabling and fatal risks particularly for children and the elderly. The standards used in clinical practice are not supported by or derived from empirical data from clinical trials, or data collected from the decades long use of neuroleptic drugs off label in clinical practice---begging the question, how did prescribing these drugs to children "off label" become a "standard practice?" This experimental use is a standard of care only because it was discussed, and adopted as a "standard" by psychiatrists. It is not because the prescription of neuroleptics is supported by, or derived from any empirical data of the safety or efficacy for the symtoms the drugs are being prescribed to children and youth to treat. In psychiatry, there are standards of care that are without support from any ethical scientific psychiatric research. Since they are not derived from or supported by the evidence base, these so-called "standard practices" are not ethical medical standards. The drugs are used off label as a "standard" treatment due to the hubris of psychiatric professionals who have determined that consensus will suffice in place of the objective evidence that theoretically is required for a particular practice to become a clinical care "standard."
I have been reading 'peer-reviewed' psychiatric journal articles for over ten years and I am still amazed at the lack of critical thinking exhibited by the psychiatrists who do the research and write the articles. The utter lack of of ethical integrity of "RESEARCH PSYCHIATRISTS" is truly stunning. The commonality is that all of them continue to repetitively state more evidence is needed to support psychiatric standards of care that are the standards psychiatrists disseminate to other professionals for clinical use; and teach to students and other medical professionals! When reporting trial results that don't support the standards used, which are the recommended 'first line treatments' that comprise the Standard of Care---does it not occur to any of these geniuses that the standards are not ethical medical standards!? Apparently, psychiatric research and clinical practice requires no critical thought...
For example, in the TEOSS drug trials, 12% of patients enrolled were "effectively treated." 97 out of the either 116 or 119 enrolled experienced a serious adverse event; the Olanzapine arm was stopped due to the number of adverse events---At the time, Olanzpine was the most widely prescribed neuroleptic drug in the pediatrics population! BUT there were no warnings for professionals to stop prescribing the drug to children...Exactly how many more children need to be subjected to what are harmful teratogenic neurotoxic drugs which may in fact disable and kill them, before "external forces" put a stop to these dorktors conducting research in their attempt to validate unethical standards of care?
As a society we need to recognize that Human Experimentation on people given a psychiatric diagnosis is not an ethical standard of care; nor is it a benificent act.
The BEST INTERESTS of the patient must come first---even if the patient is unpleasant, and even if we have been taught that the some psychiatric diagnoses mean that a patient's Human Rights can be ignored or revoked--in the interests of society... It is immoral, and it is unconstitutional. It is also the same ignorant reasoning used to implement Eugenics laws in this country that brutalized tens of thousands, and unlike the Germans in WWII, we didn't keep track of those we killed. America's program wasn't as 'successful' as Germany's, but it has left a stain. Worse than that, the fundamental social control strategies and bigotry that propelled eugenics as public policy remain embedded in our publicly funded social service and mental health programs. Sadly, the lessons learned have not remained in the general public's collective conscience...
I have been reading 'peer-reviewed' psychiatric journal articles for over ten years and I am still amazed at the lack of critical thinking exhibited by the psychiatrists who do the research and write the articles. The utter lack of of ethical integrity of "RESEARCH PSYCHIATRISTS" is truly stunning. The commonality is that all of them continue to repetitively state more evidence is needed to support psychiatric standards of care that are the standards psychiatrists disseminate to other professionals for clinical use; and teach to students and other medical professionals! When reporting trial results that don't support the standards used, which are the recommended 'first line treatments' that comprise the Standard of Care---does it not occur to any of these geniuses that the standards are not ethical medical standards!? Apparently, psychiatric research and clinical practice requires no critical thought...
For example, in the TEOSS drug trials, 12% of patients enrolled were "effectively treated." 97 out of the either 116 or 119 enrolled experienced a serious adverse event; the Olanzapine arm was stopped due to the number of adverse events---At the time, Olanzpine was the most widely prescribed neuroleptic drug in the pediatrics population! BUT there were no warnings for professionals to stop prescribing the drug to children...Exactly how many more children need to be subjected to what are harmful teratogenic neurotoxic drugs which may in fact disable and kill them, before "external forces" put a stop to these dorktors conducting research in their attempt to validate unethical standards of care?
As a society we need to recognize that Human Experimentation on people given a psychiatric diagnosis is not an ethical standard of care; nor is it a benificent act.
The BEST INTERESTS of the patient must come first---even if the patient is unpleasant, and even if we have been taught that the some psychiatric diagnoses mean that a patient's Human Rights can be ignored or revoked--in the interests of society... It is immoral, and it is unconstitutional. It is also the same ignorant reasoning used to implement Eugenics laws in this country that brutalized tens of thousands, and unlike the Germans in WWII, we didn't keep track of those we killed. America's program wasn't as 'successful' as Germany's, but it has left a stain. Worse than that, the fundamental social control strategies and bigotry that propelled eugenics as public policy remain embedded in our publicly funded social service and mental health programs. Sadly, the lessons learned have not remained in the general public's collective conscience...
I believe the fact that medical care is supposed to be in the best interests of the patient, has been lost in the debate about how to help 'the seriously mentally ill' altogether. Patients are being used as research fodder and Human Experimentation is standard psychiatric clinical practice. In Medicine, a "standard practice" is theoretically supposed be derived from and well-supported by empirical evidence that is ethically gathered and reported in an unbiased manner. In psychiatry, standards are discussed in committees and "validated" by a vote; these are not scientific methods, so the "standards" are unethical. Without empirical evidence to support a particular "standard practice" or treatment protocol it is not a "standard of care," it is nothing more than an affirmative defense for psychiatric fraud and medical malpractice.
The academic elite, Key Opinion Leaders who are members of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry are unethical psychiatrists who are desperately defending what are obviously gross departures from ethical scientific methods and ethical medical practice, inexcusable errors in judgement, and blatant abuse of power and authority. Ironically, these medical professionals are doing this while claiming it is not their ethical medical duty to treat the iatrogenic neurological impairments brain damage and physical diseases psychiatrists inflict upon their patients. It is medical neglect; it is criminal. Psychiatrists are doctors, doctors should treat the illnesses they cause instead of spending so much time defending their so-called "professional integrity." Perhaps treating the iatrogenic illnesses and injuries they are causing will remove the scales of prejudice from their eyes...
It is certain that continuing to deny the iatrogenic harm psychiatrists are causing patients while simultaneously medically neglecting the victims and frantically tryiing to validate unethical clinical care standards with federally funded seeding trials, are desperate, dishonest acts that serve only to further undermine the integrity of psychiatry as a profession. It's sheer hubris to vehemently defend unethical "standards of care" and "professional integrity," (which is sorely lacking) while maligning psychiatric survivors; adding insult to iatrogenic injury. It's not possible to regain trust with the same dishonest, unethical behavior that destroyed it.
It is certain that continuing to deny the iatrogenic harm psychiatrists are causing patients while simultaneously medically neglecting the victims and frantically tryiing to validate unethical clinical care standards with federally funded seeding trials, are desperate, dishonest acts that serve only to further undermine the integrity of psychiatry as a profession. It's sheer hubris to vehemently defend unethical "standards of care" and "professional integrity," (which is sorely lacking) while maligning psychiatric survivors; adding insult to iatrogenic injury. It's not possible to regain trust with the same dishonest, unethical behavior that destroyed it.
via Vitals NBCNews.com:
Docs: Antipsychotics often prescribed for 'problems of living'
by Sandra G. Boodman Kaiser Health News March 18, 2012
Docs: Antipsychotics often prescribed for 'problems of living'
by Sandra G. Boodman Kaiser Health News March 18, 2012
"Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia."
"In 2010 antipsychotic drugs racked up more than $16 billion in sales, according to IMS Health, a firm that tracks drug trends for the health-care industry. For the past three years they have ranked near or at the top of the best-selling classes of drugs, outstripping antidepressants and sometimes cholesterol medicines. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. And a recent report by pharmacy benefits manager Medco estimated that the prevalence of the drugs' use among adults ballooned more than 169 percent between 2001 and 2010."
"Wayne Blackmon, a psychiatrist and lawyer who teaches at George Washington University Law School, said he commonly sees patients taking more than one antipsychotic, which raises the risk of side effects. Blackmon regards them as the "drugs du jour," too often prescribed for "problems of living. Somehow doctors have gotten it into their heads that this is an acceptable use." Physicians, he said, have a financial incentive to prescribe drugs, widely regarded as a much quicker fix than a time-intensive evaluation and nondrug treatments such as behavior therapy, which might not be covered by insurance."
"Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. "Our intention here is to get doctors to reexamine prescriptions," Muzina said."
"In the short term, I don't see a change in this trend unless external forces intervene." here
"Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. "Our intention here is to get doctors to reexamine prescriptions," Muzina said."
"In the short term, I don't see a change in this trend unless external forces intervene." here
