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.