Why has it become acceptable to use factually false, or biased claims which are clearly not ethical to use when submitting information to Clinical Trials . gov? In light of the dismal failure of the TEOSS Drug Trials, there is no basis for the off label use of neuroleptic drugs, called antipsychotics, heck there isn't even evidence to support their being used as a "first-line" treatment for psychosis, or schizophrenia... Specifically, with the serious risks to overall health and mortality demonstrated in this and many other studies, should effectively demonstrate this is not a class of drugs that one would ever consider prescribing without valid evidence of it's reliability as an effective treatment specifically for what it is being prescribed for. Using neuroleptics off label is analogous to using cancer drugs off label; is that done? The conclusions from one of the numerous "peer-reviewed" journal articles that had been published on neuroleptics by the time the Metformin study was posted to Clinical Trials.gov The author of the submission to Clinical Trials. gov uses the same false claim that was used to illegally market the drugs for off label use!
The conclusions from the TEOSS drug trial article in fact do not support the statement, that the atypical neuroleptics are safer than the older cheaper neuroleptics. TEOSS was a NIMH funded multi-site 'seeding trial.' A seeding trial is one that that is conducted for the primary purpose of expanding the market for a particular drug/s. Conducting drug trials for the purpose of expanding the market is not ethical. The Metformin drug trial according to the detailed description below, is being conducted to gather data that will justify and support the off label use of neuroleptic drugs for unapproved conditions in Standard Clinical Practice; and testing the use of an additional drug to limit the weight gain of children who are prescribed neuroleptics off label. Standard Clinical Practices which are without support should not be "Standards." Conducting drug trials in an effort to justify or validate unethical clinical care standards, is simply criminal, not at all ethical. TEOSS was conducted in hopes it would produce the data necessary to gain FDA approval for the drugs that were trialed. It was a drug trial that failed to produce sufficient evidence for FDA approval, or evidence that supports using the drugs in children at all. TEOSS produced overwhelming evidence that using neuroleptic drugs in children was detrimental to the majority of children enrolled in TEOSS while a small minority 12%, were said to have benefited.
The TEOSS Trials concluded over five years ago neither the data or a final report have been made available to the American people who paid for the trial, as the law requires.
The risks for disability and death are significant for anyone given Neuroleptics. Neuroleptics and other psychotropic drugs are drugs that are teratogenic, in this respect, they are not unlike the drugs used to treat cancer---the drugs used to treat cancer, are not used "off label" and psychotropic drugs should not be prescribed off label either; especially not to children. We have psychiatrists who are defending psychiatry's unethical clinical care standards; specifically the off label use of psychotropic drugs. The standards are without the evidence to support them---what I want to know is, "How in the hell did prescribing drugs without empirical support to justify the prescription becoming 'Standard Practice'?! Clinical Trial data is supposed to be the foundation, i.e. support and validate, Standard Practice; logically, such data would need to actually exist!"
I know the answer, I find it beyond incredible that it is a Standard only because a bunch of educated (mis-educated?) people took a vote, and their 'professional opinions' were substituted for clinical research evidence, and became the basis of what are Clinical Care Standards in mental health treatment. What is being defended is the right to practice what is supposed to be a Medical Specialty, without conforming to any of the ethical standards of science or medicine.
The APA and AACAP are defending the political power they have and desperately want to keep. Psychiatry does not comply with universally recognized ethical standards of science or medicine. Psychiatry votes diagnostic criteria and diagnoses into and out of existence; whatever is voted for, makes it into the DSM. Because it votes treatment protocols and treatment algorithms into existence as well, (instead of basing them on subjective clinical trial data) the treatment standards used in clinical practice, are not ethical medical treatment standards. Without empirical support, i.e. evidence of the veracity of the claims made about the benefits of treatment; the claims are essentially fraudulent. Proceeding to offer and recommend that other professionals prescribe teratogenic drugs that are without definitive empirical support is unethical. Using the political process of consensus, psychiatry has standardized what is essentially, Human Experimentation on people who have emotional and/or behavioral problems.
This study is currently recruiting participants.
Verified June 2010 by Nationwide Children's Hospital
First Received on September 13, 2010. Last Updated on October 29, 2010
"Approximately 21 percent of children, 12-17 years old are diagnosed with DSM IV disorders, with 11 percent exhibiting severe impairment and 5 percent severe emotional difficulties. By 18 years, 1-5 percent of children are diagnosed with bipolar disorder and up to 20 percent of children with depression. As greater numbers of children and adolescents have been diagnosed with these disorders in the last 10 years, the use of psychotropic drugs in the pediatric populations has increased. Many of the drugs prescribed are the newer antipsychotic drugs olanzapine, risperidone, and quetiapine, referred to as atypical antipsychotics. Compared to the older drugs, such as haldol and thorazine, atypical antipsychotics boast an improved safety profile, with fewer side effects such as tardive dyskinesia, extrapyramidal symptoms and hyperprolactinemia. This advantage has led to providers prescribing antipsychotic more frequently not only for psychotic conditions, but also for other behavioral problems, eg., oppositional defiant disorder, mood disorders, and autism spectrum disorders. In many ways, these medicines are life saving. They protect children from the fate of psychosis, unchecked rage and agitation, allowing the them a chance to grow up more normally." here
Am J Psychiatry. 2008 Nov;165(11):1420-31. Epub 2008 Sep 15.
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.
Sikich L, Frazier JA, McClellan J, Findling RL, Vitiello B, Ritz L, Ambler D, Puglia M, Maloney AE, Michael E, De Jong S,Slifka K, Noyes N, Hlastala S, Pierson L, McNamara NK, Delporto-Bedoya D, Anderson R, Hamer RM, Lieberman JA.
Source
University of North Carolina at Chapel Hill, NC 27514, USA. Lsikich@med.unc.edu
- Am J Psychiatry. 2008 Nov;165(11):1495.
CONCLUSIONS:
The results of this study do not support the widely held assumption that risperidone and olanzapine, two of the most widely used second-generation antipsychotics, are superior to an advantageous first-generation antipsychotic for the treatment of early-onset schizophrenia and schizoaffective disorder. The safety data underscore the risks of weight gain and metabolic side effects with some second-generation antipsychotics, particularly olanzapine, and the importance of closely monitoring weight, glucose and lipid levels, and liver functioning.
These findings have broad public health implications. In the long term, the metabolic side effects of olanzapine and risperidone may place many youth at risk for diabetes and cardiovascular problems. Second-generation antipsychotics are now widely used to treat nonpsychotic mood and behavioral disorders in youth. The balance between potential therapeutic benefits and risk of adverse events needs to be carefully considered in this age group.
Further analyses from the Treatment of Early-Onset Schizophrenia Spectrum Disorders study will examine the outcomes and adverse effects of these treatments over 1 year. Additional studies with larger sample sizes are critically needed to compare the efficacy and side effect profiles of other widely used second-generation antipsychotics and midpotency first-generation antipsychotics in youth. Strategies to reduce weight gain and metabolic impact of antipsychotics must be developed and evaluated. The limited response in this study to all three medications, with fewer than 50% of subjects completing 8 weeks of treatment, emphasizes the need to develop more effective treatments for early-onset schizophrenia and schizoaffective disorder.
Presented in part at the 47th annual meeting of the New Clinical Drug Evaluation Unit, Boca Raton, Fla., June 11–14, 2007; the 54th annual meeting of the American Academy of Child and Adolescent Psychiatry, Boston, Oct. 23–28, 2007; the 46th annual meeting of the American College of Neuropsychopharmacology, Boca Raton, Fla., Dec. 9–13, 2007; and the 161st annual meeting of the American Psychiatric Association, Washington, D.C., May 3–8, 2008. Received May 21, 2008; revised June 13, 2008; accepted June 14, 2008 (doi: 10.1176/appi.ajp.2008.08050756). From the University of North Carolina at Chapel Hill; Cambridge Health Alliance, Harvard Medical School, Boston; University of Washington, Seattle; Case Western Reserve University, Cleveland; NIMH, Bethesda, Md.; Maine Medical Center Research Institute, Scarborough, Me.; and Columbia University, New York. Address correspondence and reprint requests to Dr. Sikich, University of North Carolina at Chapel Hill, CB #7160, Chapel Hill, NC 27514; Lsikich@med.unc.edu (e-mail).
Dr. Sikich has received research support from Eli Lilly, Janssen, Pfizer, Bristol-Myers Squibb, Otsuka, Seaside Pharmaceuticals, and Neuropharm and has served as a consultant for Eli Lilly, Janssen, Pfizer, Bristol-Myers Squibb, and AstraZeneca. Dr. Frazier has received research support from Bristol-Myers Squibb, Otsuka, Johnson & Johnson, Eli Lilly, Forest, Janssen, and Pfizer; she has served as a consultant to Eli Lilly; and she has served on the speakers bureau of AstraZeneca. Dr. McClellan has received research support from Pfizer. Dr. Findling has received research support from, acted as a consultant to, and/or served on the speakers bureau for Abbott, Addrenex, AstraZeneca, Bristol-Myers Squibb, Celltech-Medeva, Forest, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Neuropharm, New River, Novartis, Organon, Otsuka, Pfizer, Sanofi-Aventis, Sepracore, Shire, Solvay, Supernus Pharmaceuticals, Validus, and Wyeth. Dr. Ambler has received research support from Pfizer, Shire, Bristol-Myers Squibb, Otsuka, Abbott, McNeill/Specialty Pharmaceuticals, Eli Lilly, Sanofi-Aventis, AstraZeneca, GlaxoSmithKline, Forest, Addrenex, Johnson & Johnson, and Validus. Dr. Hamer holds stock in Amgen, Bristol-Myers Squibb, Eli Lilly, Genentech, Proctor & Gamble, and Sepracor; he has served as a consultant or advisor to Wyeth, AstraZeneca, Johnson & Johnson, Epix Pharmaceuticals, Eli Lilly, eNabledMD, GlaxoSmithKline, Solvay, Allergan, Pfizer, Schwartz, Sanofi-Aventis, Somerset Pharmaceuticals, and Corcept Pharmaceuticals; and he has received research support from Eli Lilly, AstraZeneca, and Pfizer. Dr. Hamer’s wife is a retired former employee of Bristol-Myers Squibb and, as such, holds some unexercised stock options in the company. Dr. Lieberman has served as an unpaid consultant/advisory board member for AstraZeneca, Allon, Bioline, Forest, Eli Lilly, GlaxoSmithKline, Organon, Pfizer, and Lundbeck; he has received grant support from Acadia, Merck, Janssen, Bristol-Myers Squibb, GlaxoSmithKline, Organon, and Pfizer; and he holds a patent with Repligen. The remaining authors report no competing interests.
Supported by NIMH grants MH-61528 to the University of North Carolina (Dr. Sikich), MH-61464 to the University of Washington (Dr. McClellan), MH-62726 to Harvard Medical School (Dr. Frazier), and MH-61355 to Dr. Findling and NIH Research Career Development Awards to Drs. Sikich (MH-01802 ) and Hlastala (MH-70570). Research was conducted at the Seattle Children’s Hospital, University of Washington, and at the University of North Carolina, which are supported by NIH grants RR-00037 and RR-00046, respectively. Janssen and Eli Lilly provided risperidone and olanzapine, respectively, at no cost for the study.
The authors thank the participants in this study and their families, Drs. Tyehimba Hunt-Harrison and Joseph Jackson for assistance with patient assessments, and the study coordinators, research assistants, recruiters, and referring physicians.
NIMH had no role in the study design or the collection, analysis, interpretation, or reporting of data. However, Dr. Vitiello and Ms. Ritz, who are employed by NIMH, were key investigators in the trial and contributed to data management, analysis, interpretation, and reporting. The pharmaceutical companies that donated medications had no role in the design of the study or the collection, analysis, interpretation, or reporting of the data. The content of this publication does not necessarily reflect the views or policies of NIH, NIMH, or the Department of Health and Human Services. Mention of trade names, commercial products, or organizations does not imply endorsement by the U.S. government. full article here
Clinical Trials registration: NCT00053703.
| Risperdal advertisement, Janssen-Cilag Ltd 2005 Convinced she's a siren, Tricia entices total strangers back from taxi queues and from the park for sex. To date, she's had two terminations and one divorce. RISPERDAL risperidone Because mania wrecks lives
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Risperidone may induce mania Risperidone has been used in the treatment of mania in combination with mood stabilizers, even though risperidone has also been reported to cause mania. Two new cases of risperidone-induced mania have been reported in a 23-year-old man and a 21-year-old woman, who developed acute mania with euphoria, psychomotor agitation, and hypersexuality. Neither patient experienced manic symptoms before treatment with risperidone. Some risperidone-induced mania cases were seen with low-to-moderate doses (2-4 mg/day) of risperidone; other cases with higher doses (6-9 mg/day). Güzelcan Y; de Haan L; Scholte W F. (2002) Risperidone may induce mania. Psychopharmacology 162:85-86. |
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2-23-12 originally posted updated on 10-4-2012
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