Cause and Effect: Standard Psychiatric Practice and Real World Outcomes

“We can't solve problems by using the same kind of thinking we used when we created them.”
Albert Einstein

The expert hired by the GAO to assess the report issued on an investigation done at the request of Senator Tom Carper into the psychotropic drugs prescibed to foster children is a research psychiatrist and a professor at the University of Washington.  Jon McClellan, is an expert on childhood schizophrenia, and there are countless professional journal articles, practice parameters and textbooks that he has written or contributed to which outline how to use psychotropic drugs "off-label."   The use of drugs off label is common in Medicine; however, "off-label" prescriptions are supposed to based on valid empirical evidence; and this is where psychiatry has went off the rails,  Some(all?) of the Standard Practices are developed without any relevant empirical data to support or validate them.  


"Off-label" use of psychiatric drugson children in Standard Practice is often not supported by any empirical data in the evidence base; in fact many recommendations are developed by consensus; simply because there is either insufficient empirical evidence or there is no evidence to base the recommendation on.  This is unscientific and unethical but widespread use of psychiatric drugs "off-label" with no empirical evidence to support their use is now Standard Practice in psychiatry.    


The GAO's expert, a leader in the field of child and adolescent psychiatry, acknowledged in a 2005 journal article that, "the justification for most practice is based on the adult literature or clinical consensus. Ultimately, pediatric mental health services need to be defined by research, rather than the current state whereby studies, if done at all, are initiated to justify existing practices. "  So, in effect, he is admitting that the drugs trials which provided the limited empirical data available in 2005, were conducted to validate what psychiatry had been doing in Standard Clinical Practice for years and years. The American Academy of Child and Adolescent Psychiatry had been and is still, recommending treatments to other medical professionals that have not been based on sound science or ethical medical principles.
McClellan admits that clinical drug trials have been conducted to validate existing Standard Practices; which is an admission that Standard Practices were not science-based when they were standardized and implemented by psychiatrists who encouraged others to use them as if they were. The Standards were not scientifically or ethically valid. Nonetheless, they became Standard Practices widely used by professionals who assumed the practices were derived from valid scientific research; not simply based on subjective opinions validated by a vote. A vote would not and could not transform a consensus of subjective opinions into valid scientific evidence; let alone one that could validate a treatment recommendation or standard, absent empirical data to support it. In other medical specialties, Standard Practices and treatment recommendations are derived from and based on the empirical evidence; with subjective opinions as support.  
Psychiatrists determined by a vote that a consensus of subjective opinions and anecdotal evidence could be used to validate Standard Practices and drug treatment algorithms they had been using for years without empirical evidence to support and validate them. Psychiatrists also determined by a vote that Standards for treating adults and the empirical data from drug trials for adults, is applicable to children. This short-sighted decision was necessary due to the "growing public concerns over safety, in particular with psychotropic medications," psychiatric practices were being scrutinized and needed to become (or at least appear to become) "empirically based"----


They were supposed to be empirically based from the beginning. (since psychiatry is a 'medical specialty' that is treating 'diseases' 'chemical imbalances' and/or  'neuro- biological' conditions caused by 'genetic defects')  The diagnoses themselves are determined by committee, and are voted into and out of existence by psychiatrists. It is a process which is fraught with controversy, and which has led to more and more human behaviors being used by psychiatrists to diagnose an ever increasing number of "mental illnesses"  
Psychiatry decided to claim these "mental illnesses" are caused by a disease or defect... Psychiatrists claim to be practicing science-based medicine, although psychiatrists have yet to offer definitive evidence that any psychiatric diagnosis is caused by a disease, an imbalance or a genetic defect. McClellan admits, "Variability in diagnostic and treatment practices, coupled with a lack of research, makes it difficult to stipulate which practices fall within or outside consensus or community standards. The limited validity for most childhood psychiatric disorders further complicates this issue (McClellan and Werry, 2000)

Consensus and Community Standards are not scientific standards; they are not even scientific. McClellan acknowledges, there is limited understanding of what the standards are. McClellan admits the diagnoses have limited validity, and limited understanding of what is or is not a psychiatric diagnosis, and what is and is not an effective and/or safe way to treat a diagnosis. So how is it possible to ethically declare as a scientific fact or a medical certainty that any psychiatric drug is 'effectively treating' any diagnosis?
In spite the seriously flawed methodology underlying all of this, psychiatrists have diagnosed, and have encouraged other professionals to diagnose more and more children with what are at the very least, potentially invalid diagnoses. Psychiatrists have then told children, their parents and the general public that the diagnoses are caused by diseases or biological abnormalities without offering any empirical evidence this is a valid claim. It is a claim made in hopes that it will ensure compliance with a recommended treatment protocol. A claim made with the intent to deceive, in order to benefit the professional by being perceived as an authority, and to compel compliance with a treatment protocol is fraud. It is not an ethical medical practice.
The AACAP and the NIMH and many advocacy groups state this claim as if it is a scientific fact on their websites and throughout their information and advocacy materials used to educate the public, to lobby for financial support and to formulate public policy, and to train Law Enforcement; effectively recruiting unwitting co-conspirators in their fraud. This fraudulent claim supports the interests of a criminal enterprise, not the interests of medical science and certainly not the interests of the patient. The advocacy groups are participating intentionally or not, supporting criminal activity by disseminating biased, and corrupt data as if it is valid information. As a result, widespread systemic Medicaid fraud is continuing unabated; a criminal enterprise that is openly aided and abetted by the unethical conduct of "professionals" and special interest "patient" advocacy groups.
How can anyone with a science-based or medical education not see the cause and the effect? Psychiatry has developed the diagnostic criteria, formulated and widely disseminated the treatment protocols, the diagnoses and treatments are 'discovered' by consensus and validated by a vote in the absence of valid empirical data. Both the diagnoses and the treatment protocols are the result of a political process that is quasi-democratic and takes place in secret. Members of the APA gather to determine who is and is not under their authority and control, who is going to be targeted for being adjudicated as "mentally ill" and in need of "special treatment" without their Individual Rights being effectively preserved or defended. This may not be the INTENT; however it is what is happening. I can assure you, the intent is not what victims are most aware of once they have lost their Liberty, their human dignity and/or their health; and are left with little hope of recovery.
The expert hired by the GAO, Jon McClellan, wrote some of the protocols, taught others how to use the protocols, and he has acknowledged he knew of the lack of scientific validity underlying the entire process. Consensus based diagnostic criteria and treatment algorithms being used as Standard Practices is 'the cause;' of the poor Standard of Care in Real World Practice; which becomes the cause of the patient's lousy Real World Outcome is the end effect.


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What were the parents of 18,800 children told?

Relevant data not collected: 
 the number of serious adverse events and fatalities.

The recent 20/20 reports on the Government Accountability Office Report on the use of psychotropic drugs titled, Foster Children HHS Guidance could Help States Improve Oversight of Psychotropic Prescriptions  focuses on foster children.

The report collected psychotropic prescription data on all of the children who were on Medicaid in five States in 2008; with the exception of two States that also had an HMO.  The psychotropic prescription rate data on the children served by the HMOs were not included in the GAO's report.
here are a few excerpts:
"The higher rates do not necessarily indicate inappropriate prescribing practices, as they could be due to foster children’s greater exposure to traumatic experiences and the unique challenges of coordinating their medical care." 13 (p.6)
                                                                                                                   
"Although a higher proportion of foster children received psychotropic drug prescriptions compared with nonfoster children, the vast majority of children receiving psychotropic drug prescriptions in these states were nonfoster children because the population of nonfoster children is much larger." (p.7)
                                                                                                               
footnote 14
"According to our experts, medications are approved based on therapeutic research and doses above the recommended level have generally not been shown to be safe or effective."(p.7)

"Dr. Naylor also noted that very little research has been done on the use of psychotropic drugs in foster children with severe symptoms. This limits the information available to providers on how best to treat their conditions."

"Our experts also said that no evidence supports the use of five or more psychotropic drugs in adults or children, and only limited evidence supports the use of even two drugs concomitantly in children.(p.14)"


The total cost for the drugs prescribed was $376 million dollars; $59 million of that was for children in foster care.

1,752 Children were prescribed five or more psychotropic drugs; 609 in foster care and 1,143 were living with parents. 3,841 infants one year and under were prescribed at least one psychotropic drug; 76 were in foster care, and 3,765 were in the care and custody of their parents; for a total of 5,265 prescriptions.  20,965 children were prescribed drugs which the drug was prescribed in excess of the recommended dosage and 2,165 of them were in foster care, while the rest, 18,800 in all, were living with their parents.  This last statistic includes children who were prescribed drugs for which there is no recommended dosage for children; because the drug prescribed is not FDA approved for pediatric use.  Some of these children were prescribed the unapproved drug in dosages that exceeded the recommended dosage for adults.

Clearly, psychotropic drugs are prescribed off label prior to obtaining Informed Consent; even when a child lives with a parent.
The diagnoses themselves, are derived by a consensus of subjective opinions; they are not diseases, neurobiological conditions or chemical imbalances identified using ethical, scientific, medical research methods. If any of the psychiatric diagnoses is in fact caused by a disease, the actual empirical proof of an underlying pathology remains elusive, as yet unidentified. In spite of this, parents and the children who are given psychiatric diagnoses, are routinely told the diagnosis means they have a brain disease, neurobiological dysfunction or chemical imbalance requiring psychiatric drugs to effectively, medically treat it. Why is this subterfuge not seen for the fraudulent claim that it is; instead of perceived to be ethically acceptable much less, a fraudulent claim embedded in standard clinical practices? If the claim a patient has a disease, or chemical imbalance is believed, belief in the fraudulent claim n effect, coerces a patient's cooperation with psychiatric treatment; treatment compliance is considered successful treatment.

It is unethical. 

It is Standard Practice. 

It is fraud.  

Why is it acceptable to mislead any patient, or the parents of a child patient?  The claim that a person has something wrong with their brain is a slur intended to manipulative behavior.  The claim is not based on empirical data or any medical finding.  Believing in the validity of the neurobiological disease paradigm does not give psychiatrists license to treat the hypothesis as if it were an established medical finding, it cannot transform the claim a patient has a disease that requires medical treatment an ethical claim for a prescribing professional to make.  A person is at risk of being coerced and/or having psychiatric treatment forced upon them as soon as they are labeled with a psychiatric diagnosis.

The guidelines written by psychiatrists to use in clinical practice by other psychiatrists and other medical professionals, are developed using the same quasi-democratic process used for formulating psychiatric diagnoses themnselves.  The reason for this is plain to anyone with average intelligence, who can read with comprehension.  In spite of the decades of research on some of the drugs, and decades of prescribing the drugs in standard clinical practice, the data collected, i.e. the  'Evidence Base;' clearly demonstrates neuroleptic, and other psychotropic drugs "effectively treat" only a minority of the people to whom they are prescribed.  The drugs are causing more people, children included, to develop physical, cognitive, metabolic and neurological dysfunctions that are disabling; adding to Medical costs paid by Medicaid, and other health insurance programs; and increasing disability program costs.

The data collected by the GAO confirms my suspicion that Informed Consent is not occurring in the public mental health system. Children who live with their parents are in no better position than foster children, when it comes to being "medically treated" for their symptoms of distress, and/or emotional and behavioral difficulties; if they are poor and on Medicaid. Informed Consent is barely paid lip-service by the mental health professionals I have dealt with over the past 20+ years.

Informed Consent is, (theoretically) an ongoing dialogue between a prescribing professional and a patient and the patient's guardian.  A professional who prescribes drugs has a duty that is supposed to be carried out in compliance with the Ethical Guidelines for Informed Consent.  The guidelines instruct professionals to openly share all relevant formation about the benefits and the risks of a proposed treatment, alternatives to the proposed treatment, (whether available or not). One alternative is to do nothing. The guidelines also state that the patient and/or guardian is not to be coerced or pressured into making a decision.  The guidelines even state that if the person wants to take time to consult with anyone else of their choosing, or have time to think about a proposed treatment recommendation, the professional is to be supportive of that decision. In my experience, it was not even acceptable to ask questions, let alone question their prescription!

I took psychotropic drugs for a decade, and have the heart damage to prove it---Heart damage I was told by the doctor who discovered it, is a well known risk of the drug I was prescribed.  I was never told about this risk by any of the three psychiatrists who prescribed the drug to me.  I have also never had a conversation anything close to what I described above with the last six psychiatrists who have prescribed psychiatric drugs to my son.  Last May, I was lied to about a well known negative effect my son has experienced due to neuroleptic drugs.  The lie was stated three times by the psychiatrist who looked me right in the eye and lied to me, he then demanded that I "must respect" him.

Information that professionals should be sharing prior an Informed Consent being obtained, is not being shared. It can be, and often is, due to the prescriber relying upon the work product of unethical psychiatric researchers, who exaggerate the benefits while minimizing the deleterious effects the drugs have on cognitive, neurological, hormonal, metabolic and cardio-vasular system functioning.  The fact the drugs have not been tested or approved for pediatric use is seldom a fact that is shared with parents who give consent; in effect, in effect, assent has been given, not Informed Consent. Providing accurate, complete information is an ethical duty that doesn't appear to be very highly valued by psychiatry.

We do not know what the parents of the 18,000 children who were prescribed drugs in excessive dosages, and/or prescribed for indications not supported by any evidence whatsoever, were told.

Based on my experience as a parent and advocate, 
I doubt any parents were informed about serious risks.

AMA Informed Consent

GAO Report
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