From Psychiatric drugs and common factors: An evaluation of the risks and benefits for clinical practice
a couple of excerpts:
"Finally, consider the NIMH funded Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (McClellan et al., 2007). This landmark trial, initially compared in scope to the MTA and TADS, sought to examine the efficacy, tolerability, and safety of two SGAs (Risperdal and Zyprexa) for youths diagnosed with early-onset schizophrenia spectrum disorder and to compare these to a FGA (molindone or Moban). Of the 119 participants, 41% withdrew either as a result of adverse effects or inadequate efficacy. A 17-year old boy committed suicide and an unspecified number of participants were hospitalized due to suicidality or worsening psychosis. These events are particularly disturbing in light of the fact that youths considered at
risk for suicide were excluded from the study. Weight gain (not specified) was deemed serious enough to warrant suspension of the Zyprexa arm. By 2007, reports on TEOSS are scant. The NIMH does not describe this study on its website, nor list it as an on-going or completed trial. No published reports for those responders who continued into the 44-week phase are available."
"Pharmacotherapy helps some children and adolescents. However, the preponderance of empirical research indicates that the risk may not be worth it. The Working Group asked: “how many children should benefit from an antidepressant to justify one extra child harmed. . .?” (Working Group, 2006, p. 114). They further noted that, despite evidence for all ADHD treatments, the data indicate that the benefits of medication do not maintain over time and the long term adverse effects are unstudied and unknown. Given this, the group determined that “with regard to use over a period of 2 to 3 years,
“the risk–benefit analysis of stimulant medication does not appear to be favorable because beneficial effects appear to dissipate while side effects (e.g., growth) do not” (p. 52, italics added).
The Working Group’s report omitted the controversy surrounding the risks for adverse cardiovascular events and mania associated with ADHD drugs (the report was in press before the FDA’s analysis). Adding this into the equation, confidence in stimulants as best practice for childhood behavior problems further erodes, tilting the risk/benefit analysis toward more risk free behavioral interventions. While pharmacotherapy involves considerable risk for young people, psychosocial interventions have a strong track record with virtually no adverse associated medical events (Working Group, 2006), prompting the authors to conclude: For most of the disorders reviewed herein, there are psychosocial treatments that are solidly grounded in empirical support as stand-alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Thus,
it is our recommendation that in most cases, psychosocial interventions be considered first. (p. 16. Italics added)
"In sum, the automatic prescription of psychotropic medications for adults and children, based on known risks and equivocal efficacy, is unwarranted. Where children are concerned, the stakes are higher. They are, essentially, mandated clients—most do not have a voice to say no to treatments or devise their own, and depend on adults to safeguard their wellbeing (Sparks & Duncan, in press). Clients, caretakers, and practitioners need to discern science from spin to arrive at an informed analysis of the evidence."
My thoughts about the lack of published results of the NIMH TEOSS drug trials:
The only reason I can think of for the failure to publish: there is no perceived financial/social/academic benefit to the research psychiatrists, and no perceived financial gain for the drug companies. There would be no professional accolades or media attention bestowed on the research psychiatrists which would then lead to other grant opportunities. There is no benefit conferred upon the research psychiatrists, in publishing the abysmal results---The point of the research, is to add to the evidence base for the American people's benefit; not to confer academic, or celebrity status upon the researchers!
All data is important to an Evidence Base---The data from these publicly funded Drug Trials, indeed, the data from ALL publicly funded drug trials, belongs to the American people who paid for the trials to be conducted, and should be available and readily accessible to the us. When data from publicly funded research it is not available; the American people have in effect, paid for something which we do not actually receive. The data belongs to the American people not the to NIMH, the FDA or the research psychiatrists who conduct and some are now known to have committed fraud, burying undesirable results, and publishing pseudo-results with the intent to cause doctors to prescribe a particular drug! The newer and more expensive, (not necessarily safer or more effective) drugs are invariably touted as better and recommended to be used first---The neuroleptic drugs trialed in TEOSS have since been approved by the FDA for use in children, it is a mystery exactly what the FDA's approval was based on. The Evidence Base for these drugs used on adults, IMHO, precludes (or should have) all but very limited use in children!
I am doubtful that my son was not part of the TEOSS--the drugs he was given were the very ones Dr. Jackass and his co-conspirators were using. I suspect that he may have later been enrolled in a long-term Clozapine trial---another Federally funded drug trial using adolescents as participants...No consent, no compassion, no choice, no justice---to date. These drugs were prescribed without being adequatedly, i.e. truthfully informed. Indeed, I was repeatedly told by Dr. Jackass, Jon McClellan that I had no say at all. The now widespread use of these teratogens for virtually all of the most common psychiatric diagnoses is occurring without the children who take them, or their guardians / caretakers, being given adequate information in order to give an Informed Consent. The real risks are well documented; neuroleptic drugs can have a profound adverse effect on the parasympathetic nervous system, e.g. which is why the drugs can cause cardiovascular, metabolic and endocrine systems to become chronically dysfunctional, resulting in conditions like diabetes, obesity, and heart disease.
Diabetes and heart disease are among the top ten leading causes for premature death in the U.S. and both of these conditions have become more prevalent at the same time these drugs were being crammed down the throats of those seeking help for emotional distress, and cognitive/behavioral issues. Indeed, some of the psychiatric drugs makers have been fined heavily for burying research results which identified these harmful effects---some of these drugs were approved by the FDA based on corrupt and incomplete information. None of the psychiatric drugs that FDA approval was granted based upon incomplete, biased or otherwise corrupt data; have had to undergo any further review by the FDA
While psychiatric drugs do, in fact help some people who take them, a very significant percentage--are not helped; some of these people find that even though the drugs do not help them, they are dependent upon them--or worse, forced to take them under court order. The dependence is not unusual and is well documented in the literature. There are musts, in my opinion. People must be informed (the informing and consent to drug treatments should be an ongoing dialog!) free of manipulation of facts or abuse of real or perceived authority the professional has! The risks for dependence, drug-induced neurological damage, chronic physical illnesses and death are risks which obviously need to be shared and discussed openly and honestly.
In my experience, not only are they not discussed openly, they are denied, or if acknowledged, deemed to not be relevant! These risks have never been openly discussed with me or my son by any psychiatrist who has "treated" him. In fact, when any of the risks or "side-effects" were brought up by either of us, my son's complaints and distress and my concerns were dismissed, minimized, or denied altogether---our concerns were irrelevant to every psychiatrist who has treated him for over a decade.
The Mental Health Transformation is about transparency, evidenced-based treatments and services, client and family directed care. My experiences over the last 18+ years of accessing mental health services in the publicly funded system have often been traumatizing for my family; and has ultimately altered the course of our individual day to day lives.
It is obvious that children and families need to be helped, and it should be equally obvious that the help can not ethically be based on inaccurate information and deceptive practices. Coercion and manipulation, to gain psychiatric drug "treatment compliance" is dishonest; not therapeutic in our experience. When seeking Court Orders for Involuntary Treatment, the spirit and the letter of the law should be followed. Rules of Evidence and Standard Court Procedures, attorneys that actually represent and defend their clients needs to be provided. It is not acceptable to lie about any person or event, or to attest to things that the attestor does not know "first hand" to be true -- doing so is perjury.
My family knows from experience when the legal procedures are not followed in the obtaining of Involuntary Treatment Court Orders in Yakima County Washington. Felony crimes committed by a psychiatrist and Designated Mental Health Professional were reported, but not investigated. This is what passes for "client and family directed" mental health care at Central Washington Comprehensive Mental Health.
A diagnosis of "mental illness" is not the same as a diagnosis of any other illness---I am so sure of this fact...
Read Psychiatric drugs and common factors: An evaluation of the risks and benefits for clinical practice
here.
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