Psychiatric Drug Facts via breggin.com :

“Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems… Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.” Dr. Peter Breggin
Showing posts with label Off Label Psychotropic Drugs. Show all posts
Showing posts with label Off Label Psychotropic Drugs. Show all posts

Nov 19, 2012

Who advocates for kids who are told their injuries are diseases?

Bridge of Sighs
Mothers are the necessity of invention.
Bill Watterson

I am faced with the reality that my son has been a victim of Crimes Against Humanity, the most likely outcome is that his health will continue to decline... I write my blogs and share our story in the hope that doing so may prevent another child from experiencing the same horrific mis-treatment. It is a duty that is painfully difficult. What was done to my son has had a traumatic impact on all of us. There are times I feel like I don't want to meet anyone else; I have met enough people to last me a lifetime already. 



My traumatized child was repeatedly re-traumatized by mental health professionals with seeming impunity. The greatest risks he faces today are the risks posed by mental health and social service "professionals" and their "medical instruments." These systems have no accountability; no interest in holding employees and contracted providers accountable for harm done, even if they commit crimes. This is the system that placed him in what they knew to be a "bad" foster home, and years later allowed him to be used without Informed Consent, in spite of my protests in Federally Funded neuroleptic drug trials that were seeding trials conducted with the purpose of seeking FDA approval for pediatric use of the drugs trialed. 

In the interim, between being a victim of violent crime in foster care, and being used as a guinea pig in a state-run  psychiatric facility, he was a Risperdal victim.  His "treatment" broke State, Federal and International Laws, broke my son's spirit and broke my heart. The federally-funded researcher is still in a position of authority, still in a position to harm other children in the same way he harmed my son. The man wrote practice parameters for every diagnosis children in this state are prescribed drugs off label for, and all of them recommend using psychotropic drugs off label, i.e. experimentally.  Children and their parents are told the diagnoses are caused by a disease or genetic defect-- in spite of the fact no actual disease or defect has been identified in the diagnostic process. 

This is a story they are told to gain their cooperation to be 'treatment compliant.'  It's a ploy, a method used to coerce and to control. It is the very definition of fraud. Washington State has determined that instead of giving children the care, the understanding and the support they desperately need; we will tell them they have diseases, we will give them drugs that may cause diseases, may disable them, and that may ultimately take their lives. Washington State is dedicated to this mental health "care" model. The state adopted TMAP; and hired John Chiles, MD, who is the author of the schizophrenia portion of TMAP. Chiles was paid $151,284.73 by Janssen, a subsidiary of Johnson and Johnson, the makers of Risperdal and one of the companies involved in developing TMAP. Washington State hired Chiles after the nature of TMAP was known; after TMAP had been discredited. 


TMAP is a marketing scheme, not an Evidence-Based practice. 


1 Boring Old Man


I continue to write my blogs and do what I can to draw attention to the fraud and corruption behind psychotropic drugs in general, psychiatric abuse and what was done to my son; I am hoping it will prevent the same thing from being done to anyone else. The systemic flaws and public policies which allowed and even caused the horrific mistreatment my son, remain unchanged. The crimes in which my son was victimized have never been investigated by Law Enforcement; not a single one of the  perpetrators has been held legally responsible, or experienced any consequences for their conduct. I can't help but worry about the kids who are abused, neglected and traumatized who end up in state care needing help for dealing with the reality of what has happened to them. How can not having their needs met or being abused give a kid a disease? Compassion, kindness, unconditional love i.e. providing for physical, emotional and security needs consistently is therapeutic treatment. 



Who advocates for kids who are told their injuries are diseases?
A MadMother

Nov 18, 2012

Conflicts of Interest in children's psychotropic clinical trials






via The Alliance for Human Research Protection:

Conflicts of Interest in Clinical Trials
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department
and The Henry M. Jackson Foundation for the Advancement of Military Medicine
May 5-7, 2002

Case 7: Children exposed to risks in psychotropic drug trials:

Psychotropic drugs are being tested in children despite the acknowledged risks of harm. Psychotropic drugs are advertised as normalizing a "chemical imbalance" in the brain. In fact, they do the opposite: they induce profound changes in the central nervous system with demonstrable physical and neurological impairments.[48] Dr. Steven Hyman, former director of NIMH, an expert on the mechanisms by which psychoactive drugs work, explained that, whether abused or prescribed, the mechanisms by which psychoactive drugs work are the same.[49] Hyman stated that antidepressants, psychostimulants, and anti-psychotics created "perturbations in neurotransmitter function."[50] The drugs' severe adverse side effects are symptoms of the drugs' disruptive effect on the neurotransmitter system and on brain function.

In 2001 Dr. Benedetto Vitiello, NIMH's director of Child and Adolescent Treatment and Preventive Interventions Branch acknowledged the impact of FDAMA: "pediatric psychopharmacology has recently seen an unprecedented expansion clinical trials in youths has more than doubled in the last few years."[51] Indeed, children as young as three are being recruited to test mind-altering drugs that may affect their developing brain. Parents are being offered financial inducements to volunteer their children for drug trials. The foremost problem with prescribing or testing psychotropic drugs for children is the absence of any objective criteria for diagnosing children with pathological behavioral problems to justify pharmacologic intervention. Vitiello acknowledged "diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood."[52] Vitiello also acknowledged the possibility of long-term harm: "The impact of psychotropics on the developing brain is largely unknown, and possible long-term effects of early exposure to these drugs have not been investigated."

Eli Lilly's highly touted new anti-psychotic, Zyprexa,[53] reveals much about the collision between corporate interests and the health and safety of children. In clinical trials averaging 6 weeks, Zyprexa was tested in 2,500 adults. The drug was linked to serious, in some cases life-threatening side effects requiring hospitalization in 22% of those tested.[24]Acute weight gain of 50 to 70 lbs is usual, and with it the increased risk of diabetes. FDA data (under FOIA) reveals a 65% drop out rate, and only 26% favorable response. During those 6 week clinical trials there were 20 deaths, of which 12 were suicides.[54] David Healy, who found a suicidal link to antidepressants (Selective Serotonin Re-uptake Inhibitors) in his research says, as far as he can establish, the data from these trials "demonstrate a higher death rate on Zyprexa than on any other antipsychotic ever recorded." [55] In 2000, FDA approved Zyprexa for short- term use only, in bi-polar patients. [56]

Yet, children aged six to eleven were recruited for clinical trials to test the drug. According to their published report, UCLA investigators tested Zyprexa on children who were not even diagnosed as having schizophrenia. The children were diagnosed as having a variety of questionable psychiatric disorders, including ADHD.[57] According to the published report, all the children in the trial experienced adverse effects, including sedation, acute weight gain, and akathisia (restless agitation). The trial was terminated less than six weeks after it had begun.

Controversy surrounds a Zyprexa trial at Yale University. In that experiment, 31 youngsters aged 12 to 25 who have not been diagnosed with any psychiatric illness are being exposed to the drug for one year. The stated rationale given by the researchers (who are under contract with the sponsor) is their speculation that these children may be "at risk" for schizophrenia. Since there are, as yet, no objective tests or biological markers for the illness - they hypothesize without evidence, merely on the basis of conjecture. The shaky basis for their conjecture is that assumption that the children may develop schizophrenia because one of their siblings has been diagnosed with the disorder.

The risk of schizophrenia for the general population is 1%. For siblings the risk increases from 2% to 15% - in other words there is 85% likelihood that these children will never develop schizophrenia.

Given the absence of scientifically accurate tools for interpreting psychiatric symptoms, psychiatrists cannot as yet accurately diagnose schizophrenia much less predict which children will get it. Is it ethical to expose healthy children to risks of drug- induced pathology on such speculation? The Wall Street Journal aptly noted that such a study "raises the question of whether the drug companies are mainly interested in "creating" a new illness that requires drug treatment." Read the entire report here

via Alliance for Human Research Protection:

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, including an antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.

Write to David Armstrong at david.armstrong@wsj.com

Printed in The Wall Street Journal, page B1 Complete article here
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved


via National Association  of Medicaid Directors 2012 Fall Conference:


The Problem

• MH conditions account for large share of overall illness burden and expenditure -- directly and via impact on treatment and course of co-occurring medical conditions.  

• For publicly insured, responsibility for and data on MH tx often fragmented between multiple systems; care processes and outcomes often fall short. Prescription pad often easier to access than appropriate, coordinated, evidence-based services. 

• Appropriate, safe and effective use of antipsychotic (AP) and other psychotropic medications identified by states and other stakeholders as high-priority QI issue.  High rates of off-label AP use, often without adequate psychosocial mental health services, are a concern.  

• Use patterns vary widely; uptake of evidence based practices highly uneven.  Need for more effective monitoring and management of these powerful but not risk-free treatments.

• Recent developments such as GAO report on prescribing in foster care and IG report on prescribing in nursing homes reinforce the need.

• States need tools to address these needs.Key Concerns

• Within-class and between-class polypharmacy; dosage; use in children under 6:  “too many, too young, too much.”

• High psychotropic use and polypharmacy in foster youth.

• Use in nursing home (and community) elderly with dementia, despite significant safety concerns and FDA black box warning.  

• New national concerns sparked by GAO reports on psychotropics in foster youth, and IG report on antipsychotics in nursing home elderly.  New ACYF requirements for foster youth; CMS goal of reduction in AP use in nursing homes.

• Monitoring and managing metabolic risks of antipsychotics.

• Monitoring and improving adherence (adult quality measure on consistent use of AP meds in benes with schizophrenia is a good place to start).

• MH assessment and services consistent with treatment.

• Inconsistent access to some treatments (e.g., evidence-based psychosocial interventions, trauma-informed treatments, clozapine).

Informed Consent protocol for foster kids in Washington State protects the State. Let's be real, who in their right mind would believe that it is in the "best interests" of children and teenagers in the care and custody of Washington State to have no adult/advocate to give Informed Consent for medical care? Adolescents who want and need mental health and/or substance abuse treatment should get it, regardless of familial support or familial status; pretending that kids are physically/emotionally adult enough to legally give Informed Consent BUT ONLY for psychiatric diagnoses, including alcoholism and drug addiction is unethical to say the least...morally reprehensible really. Human brains are not fully mature until the early twenties. In reality, the State of Washington  "legally" placed foster kids in harm's way by relying on a profession with a history of dishonesty, abuse of authority and abuse of "Medical" privilege. As a society, we have in effect deprived of one of the safeguards which may protect them from iatrogenic injury, or worse...

May 31, 2012

Pig Pharma and Psychiatry


Because of the attention being brought to the issue of using psychiatric drugs on children, there have been some efforts to get a handle on the over-prescribing of these dangerous neurotoxins to foster children in the State of Washington.  It would be more accurate to say  there is quite a production being made about 'taking action;' it gives the impression that the SOW is actively 'doing something,' and I am sure they are. It just doesn't seem what they are doing is making changes that focus on doing right by the children who are wards of the State of Washington.  A study conducted that was paid for by the people of the State of Washington; all of the authors are State employees and/or teach at the University of Washington, but the report is only available in a psychiatric professional journal.  Why would a study paid for by the  people of Washington State be available in a journal that the general public does not have ready access to?  It's safe to assume that most folks in Washington State do not subscribe to the Journal of the American Academy of Child and Adolescent Psychiatry; Washington's citizens paid for the study, why should we have to pay $12.00 to read the report? 

via the Journal of the American Academy of Child and Adolescent Psychiatry:

Second Opinions Improve ADHD Prescribing in a Medicaid-Insured Community Population
Jeffery N. Thompson, M.D., M.P.H., Christopher K. Varley, M.D., Jon McClellan, M.D.,
Robert Hilt, M.D., Terry Lee, M.D., Alan C. Kwan, B.A., Taik Lee, M.A., Eric Trupin, Ph.D.

Dr. Thompson, is the Director of Washington State's Medicaid programMr. Kwan, and Mr. Lee are with the Washington State Department of Social and Health Services; and Drs. Varley, McClellan, Hilt, Trupin, and Lee are with the University of Washington

Accepted 14 January 2009.

Disclosure: Dr. Varley is on the speakers' bureau of Novartis. The other authors report no conflicts of interest.

Abstract 
Objective
The appropriate use of psychotropic medications in youths is an important public health concern. In this article, we describe a review process developed to monitor the use of stimulants and atomoxetine for attention-deficit/hyperactivity syndrome (ADHD) in youths receiving fee-for-service Medicaid services.

Method
Washington State Medicaid developed threshold safety parameters for ADHD medications through a process involving the community. A second opinion was mandated when safety thresholds based on dose, combination therapies, or age was exceeded. Use and cost were compared 2 years before and after the program began.
Results

From May 2006 to April 2008, 5.35% of ADHD prescriptions exceeded safety thresholds, resulting in 1,046 second-opinion reviews. Of those, 538 (51.4%) resulted in a prescription adjustment. Adjustments were made to primary care physician (52%), psychiatrist (50%), nurse practitioner (54%), and physician assistant–written (51%) prescriptions. When the preperiod and postperiod were compared, second opinions reduced ADHD medication at high doses (53%), in combinations (44%), and for patients 5 years of age and younger (23%). The review process resulted in a savings of $1.2 million, with 538 fewer patients exceeding safety thresholds. This was a 10:1 return over administrative costs; however, the overall Medicaid expenditures for ADHD medication still increased because of higher unit costs and the preferential use by clinicians of newer brands entering the market.
Conclusions

A statewide second-opinion process reduced outlier ADHD medication prescription practices and was cost-effective. Suggestions for process and quality improvements in prescribing to children diagnosed with ADHD are discussed. J. Am. Acad. Child Adolesc. Psychiatry, 2009;48(7):740–748


"All activities outlined in this article were funded with state and federal funds through the Washington State Medicaid program. The views in this article do not constitute official policies of the state of Washington or the federal government. The authors thank the dedicated staff of Washington's Department of Social and Health Services for their tireless work in assisting Medicaid clients and balancing clinical and administrative complexities." 

(emphasis mine)  here

Why select the class of drugs used for  ADHD diagnosis and not the drugs which are prescribed off label to 'treat' the behavioral and emotional difficulties a child has?  These difficulties are often simply a child's desperate attempt to have their needs met, not diseases that require teratogenic drugs.  Pharmaceutical drugs do not address a child's need for security, appropriate supervision and unconditional love.  The environmental conditions include the deficits a child's caretaker's have; whether the deficits are due to lack of education and financial resources, or neglect and abuse .  The symptoms  of emotional and  behavioral issues are perceived by many to require a psychiatric diagnosis and psychiatric treatment.  To be clear, I am speaking about the majority of children who end up in State care who are thought to need psychiatric drugs, when the child or adolescent does not have any identifiable physiological or neurological condition.  This definition excludes most of the diagnoses applied to children, who have emotional and behavioral problems because of abuse and deprivation; the obvious solution is simply to meet their needs consistently, and then see if they need help to process the effects of being abused and neglected.  They do not need to be told they have something wrong with their brains because the adults in their lives have not provided for their needs appropriately. Their symptoms are not likely to be caused by a mysterious and still not identified underlying disease, and telling kids this myth, is dishonest.  

The decision to study the one class of drugs that is rarely used 'off-label' is suspect. The class of drugs with the most research supporting their use, are not the drugs which pose the greatest risk to children's safety. The drugs are also not responsible for the massive amounts of Medicaid fraud which continues unabated.  The Medicaid fraud should at least be a secondary priority.  The project reported in this article is part of an effort to mitigate the harm being done to children and teenagers in the foster care system by psychiatric drugs.  Why purposely target a class of drugs that are FDA-approved for pediatric use?   

It is important to address prescribing of pharmaceutical grade speed to young children.  However, the larger risk is the neuroleptic drugs, called Second Generation Antipsychotics, or SGAs, being prescribed 'off-label' prolifically; the cost of which is fraudulently billed to the Federal Medicaid program.  In order for a prescription drug's cost to be reimbursed through the Federal Medicaid program, a drug must be FDA-approved for the reason it is prescribed; or listed as having scientific support for the purpose it is being prescribed in one of the recognized Prescription Drug compendia used by HHS and Medicaid.   

Purposely targeting FDA-approved prescriptions instead of the 'off-label' prescription of drugs without FDA-approval and unsupported in the compendia is simply irresponsible and suspect.  How does this focus on pharmaceutical speed serve the best interests of the children who Wards of the State of Washington? How will it serve to protect them from the neuroleptic drugs or the SSRI antidepressants which are commonly prescribed off-label and have the potential to cause chronic, disabling and even fatal iatrogenic diseases? 

The Morbidity and Mortality in People with Serious Mental Illness report details some pretty sobering statistics for the adults who take neuropeptics and other psychotropic drugs. In spite of the disabling and fatal adverse effects of psychotropic drugs, they are used off label indiscriminately even though the risks are declared to be much more profound for children and adolescents. There is no effort to stop the prolific off label use of teratogenic drugs on vulnerable children; no plan to stop disabling and killing children. No plan to stop defrauding the American taxpayer. This may be because we are expecting those we entrusted (the same professional group that initially recommended the drugs off label for pediatric use) to slow down the obscene proliferation of off label prescribing--- 

It goes without saying, but I'll say it anyway, these professionals are defending Human Experimentation on children which is now a Standard Clinical Practice, but is not ethical or "necessary medical treatment." It's a human rights crime. 


It appears that they are not serving children's best interests;
 they are serving the interests of  Pig Pharma...  

  Photo Credit

Dec 2, 2011

Jon McClellan's testimony to the US Senate



The fact of the matter---as Jon McClellan is well aware---Washington State had absolutely NO psychotropic drug policy for children in State Custody until after I brought my son home in January of 2005.  In the process of researching how I could to rescue my son from the Washington State children's psychiatric facility he referred to in his testimony as, "my State hospital;" I discovered that Washington State in fact had no mechanism or protocol to provide for Informed Consent to protect children in Washington State custody.  I informed Children's Administration that I was not going to just go away---just because I was able to force them to comply with the Law and return my son to me---didn't mean that I was going to forget what I had learned.   


The Psychotropic Drug Policy was developed within a couple months of Isaac's return home, and is titled "The Dope on Drugs." In my opinion, the policy protects primarily the State of Washington.  It is plain to me that Washington State's Psychotropic Drug Policy was developed to protect prescribers, the State of Washington, and the State's employees and contracted Mental Health Service providers from liability.  It is my opinion that the policy as written ensures that the children in State custody are still available to use as guinea pigs in research; can be given psychiatric drugs EXPERIMENTALLY with impunity while giving the appearance of protecting foster children in State custody from harm.


It is in fact experimental to give drugs "off-label" for symptoms and diagnoses for which the drugs have not been FDA approved; to give drugs to children that have not been tested for safety and efficacy in children and do not have FDA approval for pediatric use; is the definition of Human Experimentation. the term, "off-Label" sounds innocuous, which is why it is used; it makes Human Experimentation acceptable, but calling it a "standard practice" belies the truth, and does not meet the STANDARD for being given the distinction.

The policy offers the children in state custody very little care or protection in real world terms. The reason I say this, is two-fold.  Primarily, it is because the policy would not prevent what was done to my son from happening to another child. In fact, it in effect, allows Jon McClellan to use children in Drug Trials without the parent's consent. The final paragraph on the second page of Washington's psychotropic drug policy for children in state care states, "The informed parental consent or court order needs to be a general authorization for the administration of psychotropic medications at the direction of a qualified, licensed physician so that a change in the consent or court order is unnecessary when there is a need for the physician to adjust the medication."  H
ow could any reasonable person believe that a one time general consent is even ethical, much less claim that a one time general consent will protect a child from being harmed from teratogenic psychotropic drugs? It is simply ludicrous. A one time general consent is simply for the State of Washington's convenience; it does little to protect children from iatrogenic harm. 


When developing a policy to protect and defend children, it is unwise to proceed as if they do not have the same needs as everyone else; to offer them LESS than we would expect for ourselves and our own children, speaks to the lack of thoughtful consideration given to protecting children in State custody. So what purpose does this policy serve? The policy does not serve the purpose to protect children in state care so much as it serves to  cover the State's ass while putting on a "show of protection;" for state wards.  A one time general consent is, on the face of it, unethical; it does nothing more than pay brief lip-service to what Informed Consent actually entails.  This policy is a shameful excuse for an effort that is supposedly intended to protect children.  There is no way in hell a general authorization would be sufficient to protect a child against the type of off label drugging of emotional and behavioral problems quantified by this investigation. (The THIRD US Senate investigation into psychotropic drugging of children on Medicaid) It is because Jon McClellan and other members of the American Academy of Child and Adolescent Psychiatry have written practice parameters and treatment algorithms based on consensus which were then "validated" and implemented as Standards of Care by consensus, that this investigation is even necessary.  

Washington's policy is "Interim Policy  97-10" and I first printed it on March 9, 2005--two months and three days after I brought my son home from Child Study and Treatment Center; it is still exactly the same and still fails to protect the children even half as much as it protects the State of Washington and unethical medical practitioners.


Another interesting thing about this policy is that it does not list even one of the newer, most prescribed, neuroleptic drugs like Risperdal, Seroquel, Geodon, Abilify, EVEN though these new neuroleptics are being prescribed off-label as a matter of course, and are on Washington's "Preferred Drug List" which are fraudulently billed to the Federal Medicaid Program. I say fraudulently, because in 2005, these drugs were not FDA approved for use in children, therefore not qualified for reimbursement through the Federal Medicaid program.  The only neuroleptics listed on this policy were the older, cheaper neuroleptics only Thorazine was approved for use in children with schizophrenia:
Chlorpromazine/ThorazineHalperiodal/Haldol
Trifluoperazine/StelazineThioridazine/Mellaril
It is unchanged to this day. here is the link


From Isaac's Treatment Record at Child Study and Treatment Center: 
The Report from the Evaluation and Treatment Conference lists Jon McClellan as the "Team Leader" dated 10-8-2001 and covers a two month period leading up to this conference, lists his current medications as: Zyprexa, 20 mg. at bedtime,  since 9-7-2001.  Zyprexa was started on 8-27-01 at 5 mg. increased to 10 mg on 8-30-2001 and increased to 15mg. on 9-4-2001.  Risperdal 3mg. twice a day increased from 2mg. twice a day on 9-6-2001.  Ativan .5 mg 3 x a day and 1 mg every four hours as needed not to exceed 6 prn doses in 24 hours, the report states the Ativan was adjusted several times beginning on 9-7--2001 when he was on 1 mg 3x a day.  The Ativan was prescribed "in hopes of controlling Isaac's impulsive behavior"----not an indicated or approved use, for this highly addictive drug meant for short-term use---Another oddity of this report, is that it lists Cogentin 1 mg. as being started on 10-20-2001----although the entire report  was prepared for a Review which took place on the 8th of October 2001.  Thorazine discontinued on 8-16-2001, and a brief trial of Seroquel discontinued on 8-5-2001.  
What this all means is that Jon McClellan had my son who was thirteen, on at least two and at times three neuroleptic drugs, that were not approved for use in children; the only neuroleptic drug approved for pediatric use at the time was Thorazine. The reason Jon McClellan claimed he did not need my consent is Washington State's Age of Consent Law for mental health and substance abuse treatment is thirteen. The purpose of this law is supposedly in order to enable kids whose parents are not supportive to access any substance abuse and mental health treatment they need.  It is used by some professionals to exclude parents.  My son may have been thirteen but it would have been obvious to a bright grade-school student that Isaac was totally in his own world; he lacked the capacity to give consent.   The other reason he cited was illegal---he told me repeatedly, that since Isaac was a Ward of the State, he did not need my approval or consent.   He actually said it was a "courtesy" for him to tell me anything about the drugs he was giving my son; not a requirement.  State Law, Federal Medicaid Guidelines, the US Constitution, the Ethical Guidelines for Informed Consent and the Nuremberg Code all required that my consent be obtained; but Jon McClellan claimed he didn't need it!  


In fact, when I was forced to relinquish custody of Isaac "voluntarily" I was assured that I would not lose my parental rights to provide consent to his treatment.  I was forced to relinquish custody in violation of Federal Medicaid Law and Federal Child Welfare Policy by Washington State DSHS Region II Children's Administration staff who falsely claimed that it was required so Medicaid would continue to pay for Isaac's medical care.  This was  a lie used to coerce me to "sign a Voluntary Consent to Place Agreement.  I believe this fraud was perpetrated so that the State of Washington could fraudulently collect foster care reimbursement funds to help pay the cost of his care.  I was further manipulated into signing the agreement by the Children's Administration caseworker, who informed me if I refused to sign it, she would tell the Judge I was unable to act, "in my son's best interest."


I only learned this past year that the one time the law allowed for me to enter into the Court Record my take on the proceedings, was at that specific hearing.  My son had by this time gone without the recommended treatment for his Left  Temporal Lobe Epilepsy and PTSD for six years.  Isaac had PTSD as a result of being violently assaulted and put in a closet in foster care when he was three. God only knows what else happened to him before that---The State of Washington does not have on record where he was for the two whole months prior to being placed in Margaret Manson's home where he was victimized.   Jon McClellan knew Isaac had been victimized--he put it in his medical record stating that it was reported to CPS the first time Isaac was in Child Study and Treatment Center in 1995.

Why is it that I found no consent protocol for children in State Custody when I looked for one, and when I asked Children's Administration for a copy---there was nothing to give me? In 1997, a six-year-old boy, Domico Pressnell, died in foster care from the effects of taking multiple psychotropic drugs as prescribed---AND "Following the death of Domico Presnell, Washington's policies and procedures for the administration of psychotropic drugs to foster children came under withering scrutiny. Ultimately the case changed the way DSHS administers and allows drugs to be administered to foster children. The message went out powerfully to state administrators, foster care caseworkers and foster caregivers themselves that negligence will come at a steep price for everyone involved." Obviously, this statement is overly optimistic; DSHS administrators, didn't get the message...


Jon McClellan helps formulate Public Policy about Mental Health Treatment Services for children who are Wards of Washington State, and for children across the Nation---He has been published extensively in professional journals and is regularly quoted in National News outlets.   Due to my personal experiences witnessing Jon McClellan "medically treat" my son, and from what I know about his research, I found his testimony in the US Senate disingenuous.  Jon McClellan has been on the faculty at the University of Washington, for over two decades, and supervises interns at Children's Hospital and Medical Center in Seattle, and Child Study and Treatment Center in Lakewood.  The man is listed as the sole author, if not listed among the authors, of Practice Parameters and Treatment Protocols for virtually every psychiatric diagnosis given to children.  He was on the editorial board for the Professional Journal put out by the AACAP, a journal that still refuses to retract the reports of Study 329, an utterly fraudulent Drug Trial that falsely reported the safety and efficacy outcomes for the drug Paxil; including not reporting fatal outcomes of clinical trial participants.  The drug was FDA approved as "safe and effective for pediatric use" because of falsely reported results from Study 329. 
  

The writtenTestimony of Jon McClellan in it's entirety:
Statement of Dr. Jon McClellan

Professor

University of Washington
Seattle, Wa
Senate hearing: December 1, 2011
“The Financial and Societal Costs of Medicating America’s Foster Children”
McClellan Testimony: Psychotropic Drugs in Children
2
Mr. Chairman and Members of the Subcommittee; thank you for inviting me to participate in this important discussion regarding the use of psychotropic medications in foster children.
I am a Child Psychiatrist at Seattle Children’s Hospital, a Professor at the University of Washington, and the Medical Director of Child Study and Treatment Center, the State psychiatric hospital for youth in Washington State.
The high risk practices identified by the GAO study raise significant concerns regarding the treatment of severely mentally ill and vulnerable youth. Although the focus of this study is on foster care, the concerns raised are relevant to all children and adolescents prescribed psychotropic drugs.

Children in foster care often have emotional and behavioral difficulties. The high rate of medication use in this population is not a new discovery, nor does the use of these drugs always imply bad practice. Several psychiatric medications have been studied and approved for use in children and adolescents. When prescribed correctly, these treatments can help reduce suffering and enhance the functioning of young people.
McClellan Testimony: Psychotropic Drugs in Children
3
However, it is also well documented that many children in the child welfare system do not receive high quality psychiatric services. Treatment too often occurs during times of crisis, without adequate support or access to skilled clinicians and programs capable of providing effective social and behavioral interventions.
In these situations, medications become stopgaps, used to prevent the child from hurting themselves or others, or to help control disruptive behaviors that threaten the child’s foster placement. The lack of effective long-term treatment exacerbates the risk for excessive and inappropriate medication use.

This problem is evident in the patterns of high-risk prescriptions identified by the GAO study. As a group, children in foster care were more likely than other children to be treated with multiple psychiatric drugs, and also were more likely to be treated with dosages that exceed recommended standards of care.

These practices impacted thousands of children. Some young people were prescribed as many as 10 different psychotropic drugs at the same time. Some children younger than 5 years of age were prescribed as many as 5 different medicines concurrently.

4
Unfortunately, such practices are not uncommon. At my State hospital, kids are often admitted taking four or more medications. A few years ago, one young boy admitted to Seattle Children’s Hospital was taking 13 different psychotropic drugs. There is no research that justifies these practices.

The most troubling finding of the GAO study is the use of psychotropic drugs in infants. Most of the prescriptions in babies were for antihistamines, some of which may have been used to treat other types of medical problems. Regardless, there is little research supporting the use of these medicines in very young children, and the prescriptions are concerning.

Furthermore, dozens of babies were prescribed antipsychotics, antidepressants, clonidine or lithium. Some infants were prescribed more than one drug. The use of psychotropic medications in babies defies both standard of care and common sense.

The findings of the GAO study strongly suggest the need for better oversight. The Best Principals outlined by the American Academy of Child and Adolescent Psychiatry provide a useful set of monitoring guidelines.

5
Washington State has implemented a model system to oversee psychotropic drugs. Criteria were developed to identify prescriptions that exceed safety thresholds, based on dose, number of medications or age of the child. For prescriptions flagged by this process, a second opinion by a child psychiatrist is required before the medication is dispensed. This oversight system has reduced high-risk prescriptions, and over a two-year period, saved the State 1.2 million dollars.

The results of the GAO study also strongly call for more research. A hodgepodge of prescribing practices occurs in part because none of our current treatments work well enough. Genetics and neurobiological sciences have advanced substantially over the past decade, in large part due to the leadership of the National Institute of Mental Health. Nonetheless, given the marked complexity of brain functioning, the underlying causes of most psychiatric illnesses remain unknown. Without known causes, research on intervention inevitably struggles. We need continued investment, both fiscal and intellectual, in order to develop safer and more effective treatments, and to eventually find cures.
Thank you for listening.    (emphasis mine)


I would love for this "doctor" submit evidence in compliance with the Rules of Evidence required in every other type of civil or criminal proceeding in Courts of Law,  except Involuntary Commitment hearings. There are none.  It is a hypothesis that a genetic or neurobiological defect or disease causes any/every psychiatric diagnosis/es.  Jon McClellan's statement is  not "testimony" in an ethical medical or legal sense; it is more an excuse, justified by a presumed privilege.  There is not any scientific basis or an ethical medical purpose for prescribing teratogenic drugs to children and adolescents, based on a hypothesis alone, since real world risks are disability and death.  Jon McClellan is one of the psychiatrists who has led the way in recommending "a pill for every ill" psychopharmacology is the new psychiatry psychotropic drug marketing campaign.


Practice Parameters and Treatment Protocols are followed by psychiatrists, and other medical professionals. These parameters and protocols recommend drugs without the recommendations having definitive, empirically validated support.  Jon McClellan's "testimony" was not the truth and nothing but; it was more of a self-serving defense of the bio-psychiatry pharmaceutical treatment paradigm; with no evidence offered for the validity, safety, and/or effectiveness of this "psycho-pharmacological treatment." Drugging children for what may be the effects of abuse, deprivation and trauma as if the effects (their injuries) are evidence the child has an unidentified genetic or neuro-biological condition; is social and political control of children and/or their parents; not medicine. Clearly to NOT address the real world environmental and inter- and intra- personal deficits which are clearly causal factors; adds insult to injury, to say the least.


While deprivation, and physical abuse can cause biological damage, and the detrimental effects of trauma--particularly a brain injury, can cause neurological deficits, as well as behavioral, emotional and social difficulties, does that mean a child who has had these horrific experiences has a disease that is neurobiological and/or genetic in origin?   According to Jon McClellan, apparently, that is what it means---I wonder how a normal child can become genetically and/or neurobiologically diseased and/or defective, from not having their needs consistently met?  There is a major difference between genetics and epigenetics... How is it that the failings of the adults in children's homes, and in their communities is not seen for the causal factors that they are, but instead minimized or dismissed while it is claimed that children are mentally ill due to an unidentified (illusory)  neurobiological disease and/or a genetic defect? 


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