My hope is for all of us

"Methamphetamine - The only feature that greatly distinguishes this congener of amphetamine from amphetamine itself is the exceedingly large number of trade names under which this material is sold: to name some, Amphedroxyn, Apamine, Deofed, Desamine, Desoxedrine, Desoxo-5, Desoxyephedrine, Desoxyn, Desvphed, Detrex, Dexoval, Dexstim, D-O-E, Doxyfed Drinalfa, Efroxine, Lanazine, Methamphin, Methedrine, Methoxyn, Miller-Drine, Xorodin, Oxyfed, Oxydess, Premodrin, Normadrine, Xorodin, Semoxydrine, Stimdex, and Syndrox. There is no evidence that its action differs from that of amphetamine in any way except that the action on the cardiovascular system is somewhat less intense and the action on the central nervous system is somewhat more intense. This drug is probably abused more than any other of the group."
-- Diet pill (amphetamines) traffic, abuse and regulation: hearings before the Subcommittee to Investigate Juvenile Delinquency of the Committee on the Judiciary, United States Senate, 92nd Congress, February 1972.

The Diagnostic and Statistical Manual is touted as a resource by bio-psychiatry devotees, while it is maligned by others skeptical of it's scienticic validity.  It is a manual developed by a relative few, who vote on which behaviors are socially unacceptable and signify that a person has a "mental illness" or brain disorder.  In the case of a person labeled who does not agree to having a psychiatric diagnostic label applied, the person is given an additional diagnosis borrowed from neurology, "anosognosia;" which is a lack of insight.

What is most troubling to me about the Diagnostic and Statistical Manual is that is believed to be a resource based on scientific data by the uninformed. Subjective observation and opinion is considered to be the most unreliable type of evidence in science; yet it was heavily relied upon and even used as a substitute for empirical data by the APA when the DSM was first developed and in all subsequent revisions. Every other field of scientific study treats subjective data as if it is unreliable, and it's use is limited to supporting available empirical data. I'm not claiming there is no science behind the DSM; what I am pointing out is the APA relies on consensus which is a quasi-democratic political process; not a scientific one. Consensus is relied on in the absence of empirical data, not to support empirical data. Even educated opinions can not be the basis of ethical diagnostic criteria or ethical medical treatment algorithms and protocols. A medical degree and medicial license do not make professional opinions unbiased, or scientifically valid. Even a a consensus of educated subjective observations can't be empicical evidence that validates diagnostic criteria or treatment recommendations; consensus is a quasi-democratic political process, not a scientific method. Consensus also can't validate the specious claim that psychiatric diagnoses are diseases, or caused by neurobiological diseases or chemical imbalances that require psychiatric treatment. If a patient refuses to give consent for treatment, the APA endorses compelling the person to be forced to have psychiatric treament under color of law by petitioning for court orders requiring involuntary psychiatric treatment. Perhaps it is group delusion that causes members of the APA to believe consensus is a sufficient substitute for empirical data. It is not.

I started writing Involuntary Transformation September 4th, 2010 because of how the political process of psychiatric diagnosis and treatment has been carried out in my son's case.  In the summer of 2010 for the first time in over five years he had a crisis due to attempting to process his pain-filled childhood memories. He said he wanted to be hospitalized, and so his elder brother and I accompanied him to the Crisis Center.  Nancy Sherman, the Designated Mental Health Professional committed two felonies to have my son Detained under Washington State's Involuntary Commitment laws; committing perjury and forgery to "support" her Emergent Order to Detain.   Jeffrey Jennings, a psychiatrist, committed perjury (providing only the same false information Ms. Sherman provided in her original order, not first-hand information as the Law requires--he had no 'first-hand information).  Jennings 'treated' my son without regard for the Hippocratic Oath, or Medical Ethics; never speaking to anyone who knew Isaac the entire time he was his 'attending' physician.  The Deputy Prosecutor, Dan Polage,  and the attorney from Yakima County's Office of Assigned Counsel, Jennifer Lesmez,  both failed to conform to the Ethical Guidelines of the Legal profession--as both of these Officers of the Court were aware that perjured testimony was being used.  The Crisis Center is run by Central Washington Comprehensive Mental Health and this medicaid provider shredded all the original Superior Court Documents in violation of Washington State Law.  The CEO Rick Weaver, told me, "We do it all the time."

I'm not a doctor, or an attorney; I am a mother.   I am outraged at the utter lawlessness with which psychiatry is practiced.  The events of a year ago were not the first time I have witnessed my son being seriously harmed by unethical "professionals;" and it may not be the last; but as God is my witness, I will not be silent about crimes victimizing my son.  It is MY little boy who is now a grown man struggling with the reality of being repeatedly traumatized by unethical mental health professionals that "were supposed to be helping me" but "had no compassion for me, mom" he stated shortly before his crisis in 2010.  He asked me in an agony-filled voice, "How could they take so much from me, mom?" I'm at a total loss to explain the callous disregard shown to my son.

My memories of the past almost twenty years are filled with instances--too many to count, of my son speaking of his pain-filled experiences. I have many times felt crushed by the knowledge I was not allowed to protect my own son. Worse, I was prevented from fulfilling his agonized pleas for rescue. These horrific experiences left me utterly devastated. I don't wish to forget my own experiences of bearing witness to my son's torture; I know some horrors must never be forgotten...

"IF we want to understand violence as a whole, we cannot leave any of its major manifestations in a fog of half-knowledge. But this is exactly what has happened with an unprecedented occurrence of mass violence, the deliberate killing of large numbers of mental patients, for which psychiatrists were directly responsible. To both the general public and the psychiatric profession, the details and the background are still imperfectly known. This is not only a chapter in the history of violence; it is also a chapter in the history of psychiatry. Silence does not wipe it out, minimizing it does not expunge it. It must be faced. We must try to understand and resolve it." FREDRIC WERTHAM, M.D A Sign for Cain An Exploration of Human Violence 1966

I have two reasons for writing the Involuntary Transformation and Systems of Care blogs...The first is in the hope it may help prevent another child from being mistreated by mental health professionals like my son has been; I believe it is the only way Justice can be served. Whether justice is served or not will not be determined by me; it will be determined by all of us. I sustain hope for Isaac's recovery and a better life for Isaac, his brother Nathan, and myself. My hope is not for my family alone, my hope is for all of us. Psychiatric diagnoses are arbitrarily applied and legally adjudicated under color of law to treat the individuals who are unwilling to be arbitrarily labled with a psychiatric diagnosis; unwilling to be "sucessfully treated," i.e. treatment compliant.

The other reason I write two blogs is my belief that if I were silent about what was done to my son and my family, I would be complicit in what are crimes against humanity. I will never be complicit. I witnessed Isaac being horribly abused and medical neglected by psychiatric researchers who acted under color of law when they tortured and disabled my son Isaac in a locked research facility.

From the British Psychological Association's Response to the American Psychiatric Association:

DSM-5 Development:

General Comments

"The Society is concerned that clients and the general public are negatively affected by the continued and continuous medicalisation of their natural and normal responses to their experiences; responses which undoubtedly have distressing consequences which demand helping responses, but which do not reflect illnesses so much as normal individual variation.

We therefore do welcome the proposal to include a profile of rating the severity of different symptoms over the preceding month. This is attractive, not only because it focuses on specific problems (see below), but because it introduces the concept of variability more fully into the system. That said, we have more concerns than plaudits.

The putative diagnoses presented in DSM-V are clearly based largely on social norms, with 'symptoms' that all rely on subjective judgements, with little confirmatory physical 'signs' or evidence of biological causation.  The criteria are not value-free, but rather reflect current normative social expectations.  Many researchers have pointed out that psychiatric diagnoses are plagued by problems of reliability, validity, prognostic value, and co-morbidity.

Diagnostic categories do not predict response to medication or other interventions whereas more specific formulations or symptom clusters might (Moncrieff, 2007).  Finally, disorders categorised as ‘not otherwise specified’ are huge (running at 30% of all personality disorder diagnoses for example).

Personality disorder and psychoses are particularly troublesome as they are not adequately normed on the general population, where community surveys regularly report much higher prevalence and incidence than would be expected.  This problem – as well as threatening the validity of the approach – has significant implications.  If community samples show high levels of ‘prevalence’, social factors are minimised, and the continuum with normality is ignored.  Then many of the people who describe normal forms of distress
like feeling bereaved after three months, or traumatised by military conflict for more than a month, will meet diagnostic criteria."  read the entire response: The British Psychological Association on DSM 5 

this is one of Isaac's favorite songs

Eli Lilly Amphedroxyn (methamphetamine) advertisement, 1951. 

New York State Journal of Medicine, Vol. 51, No. 1.

Elixir Amphedroxyn Hydrochloride (Methamphetamine Hydrochloride, Lilly)
IS OFTEN PREFERABLE TO OTHER FORMS OF AMPHETAMINE ~ because ~ smaller doses produce longer cerebral stimulation, with a minimum of undesirable excitement and other side-effects.
When patients with depression, narcolepsy, alcoholism, or obesity are selected as suitable cases for stimulant therapy, Amphedroxyn Hydrochloride is a prudent choice of drug.
Contraindicated in cardiovascular diseases, especially when accompanied by hypertension, hyperthyroidism, and sensitivity to ephedrine-like drugs.
CAUTION ~ To be dispensed only by or on the prescription of a physician. Literature available to physicians on request.
Detailed literature on Amphedroxyn Hydrochloride are personally supplied by your Lilly medical service representative or may be obtained by writing to Eli Lilly and Company, Indianapolis 6, Indiana, U.S.A.
LILLY Since 1876 

*         *         *  vintage drug ad via Bonker's Institute of Nearly Genuine Research
first posted 8-5-2011  revised 4-17-12,  4-3-2014

Off Label: Neuroleptic prescriptions are fraudulently billed to Medicaid

,

via Bonkers

via Health Services Research:
Best of the 2012 Academy Health Research Meeting
The Relationship between Mental Health Diagnosis and Treatment with Second-Generation Antipsychotics over Time: A National Study of U.S. Medicaid-Enrolled Children

In 2002 7,990 3-5 year old children on Medicaid were given 3 or more psychiatric diagnoses and 1804 of them were prescribed neuroleptic drugs off label in the U.S.  In 2007, 13,934 were given 3 or more psychiatric diagnoses, and 3,341 of these pre-school aged children were prescribed neuro-toxic neuroleptic drugs whose adverse effects include cognitive and neurological impairments that can be disabling, and even fatal...

Appendix table 3A Frequency and Rates of Diagnosis and SGA Antipsychotic Treatment
Among US Medicaid Enrolled children 3-5 years old from  Best of the 2012 Academy Health Research Meeting  "The Relationship between Mental Health Diagnosis and Treatment with Second-Generation Antipsychotics over Time: A National Study of U.S. Medicaid-Enrolled Children"

click to enlarge

As horrifying as the above information is, it is the the data on young children with a diagnosis of schizophrenia and the data on who is being prescribed neuroleptics that is inexplicable.  Schizophrenia is the one diagnosis that both the APA and the AACAP practice parameters authoritatively state neuroleptics, or antipsychotics are to be used as a "first-line treatment." Some psychiatrists go so far as to say that it would be "unethical" to not treat symptoms of schizophrenia with this class of teratogenic drugs, a questionable claim, all things considered. In this study, 78 preschoolers were diagnosed with schizophrenia in 2002; of these 78 children given a diagnosis of schizophrenia, only 6 were prescribed neuroleptics.  In 2007, there were 92 children labeled with schizophrenia that were 3-5 years old; not a single one of them was prescribed a neuroleptic drug according to the above reference chart. 

6-11 year old children on Medicaid pdf download

                                              #on   %on      %Total                           #on     %on      %Total

                     total#       dx%    SGA  SGA         SGA      total#   dx%     SGA     SGA      SGA

Schizophrenia  278       0.01%   82     29.50%     0.10%    311    0.01%   66     21.22%   0.05%

12-18 year olds on Medicaid pdf download

                                                #on   %on        %Total                         #on     %on    %Total 

                       total#       dx%    SGA  SGA         SGA     total#       dx%  SGA    SGA     SGA

Schizophrenia   1,571   0.03%    965    61.43%     0.74%   1,537    0.03%   871   56.67%  0.40%

The prescription rate for neuroleptics to treat schizophrenia went down, while the rate of off label prescriptions for non FDA-approved conditions have risen dramatically. An alarming trend that is bound to get worse when the DSM5 is released; some children are drugged absent any psychiatric diagnosis whatsoever. Many children who are drugged are given 2, 3, or more psychiatric diagnoses; and the children are then prescribed multiple drugs concomitantly, all off label, and without any definitive data it is safe or effective to prescribe the drugs in the manner they are most often being used.

The study was paid for by the Agency for Healthcare Research and Quality, a federal program whose budget is derived from federal tax dollars, and it is copyrighted by the Health Research and Educational Trust.  This begs the question, why is it not easily accessible to the American people who paid for it? It is on the Wiley Online Library behind a pay wall requiring that you buy the PDF or pay for 24 hour access to it online, unless you're a health professional affiliated with an institution that is a Wiley Library subscriber.  

Best of the 2012 Academy Health Research Meeting

The Relationship between Mental Health Diagnosis and Treatment with Second-Generation Antipsychotics over Time: A National Study of U.S. Medicaid-Enrolled Children

Meredith Matone M.H.S.1,
Russell Localio Ph.D.2,
Yuan-Shung Huang M.S.3,
Susan dosReis Ph.D.4,
Chris Feudtner M.D., Ph.D., M.P.H.1,3,5,
David Rubin M.D., M.S.C.E.1,3,5,*

Article first published online: 4 SEP 2012

DOI: 10.1111/j.1475-6773.2012.01461.x

© Health Research and Educational Trust


Issue


Health Services Research


Volume 47, Issue 5, pages 1836–1860, October 2012

Funded by
Agency for Healthcare Research and Quality

Keywords:

Antipsychotics;
mental health;
pediatrics;
Medicaid

Objective
To describe the relationship between mental health diagnosis and treatment with antipsychotics among U.S. Medicaid-enrolled children over time.

Data Sources/Study Setting
Medicaid Analytic Extract (MAX) files for 50 states and the District of Columbia from 2002 to 2007.

Study Design
Repeated cross-sectional design. Using logistic regression, outcomes of mental health diagnosis and filled prescriptions for antipsychotics were standardized across demographic and service use characteristics and reported as probabilities across age groups over time.

Data Collection
Center for Medicaid Services data extracted by means of age, ICD-9 codes, service use intensity, and National Drug Classification codes.

Principal Findings
Antipsychotic use increased by 62 percent, reaching 354,000 youth by 2007 (2.4 percent). Although youth with bipolar disorder, schizophrenia, and autism proportionally were more likely to receive antipsychotics, youth with attention deficit hyperactivity disorder (ADHD) and those with three or more mental health diagnoses were the largest consumers of antipsychotics over time; by 2007, youth with ADHD accounted for 50 percent of total antipsychotic use; 1 in 7 antipsychotic users were youth with ADHD as their only diagnosis.

Conclusions
In the context of safety concerns, disproportionate antipsychotic use among youth with non-approved indications illustrates the need for more generalized efficacy data in pediatric populations.

When anecdotal evidence is sufficient for standard practice, adverse events are dismissed as anecdotal

“ . . . No one is really paying attention to what’s going on. . . The issue is how many Medicaid kids are being drugged to death, not how many kids in fostercare are being over medicated." Grace. E. Jackson, M.D., Author: Rethinking Psychiatric Drugs: A Guide for Informed Consent and Drug-Induced Dementia: A Perfect Crime

via The American Academy of Child and Adolescent Psychiatry:
A Guide for Community Child Serving Agencies on Psychotropic Medications for Children and Adolescents

a couple of excerpts:
"A child who is difficult to manage or has a mood disturbance may benefit from medication if there is scientific or clinical evidence that the medication is safe and effective for the specific diagnosis or behavioral indication." (emphasis mine)

"When a youth has been taking a medicine for a long period of time, the brain may have become used to it, and abrupt discontinuation can cause side effects that should not be mistaken to mean that the medicine is still needed.  For this reason, a decrease in dosage or discontinuation must be conducted gradually. This does not mean that the youth is addicted to the medication but rather that the youth’s brain has become used to the medication and that discontinuation must occur gradually so that the brain has time to adjust."

"Some psychotropic medications have FDA Black Box Warnings. Medicines with black box warnings are still FDA approved, but their use requires particular attention and caution regarding potentially dangerous or life threatening side effects. Selective Serotonin Reuptake Inhibitors (SSRI’s) carry a black box warning that they may cause suicidal ideation or behavior, although the most recent review of the evidence is not conclusive that SSRIs increase suicidal behavior. Families should work in consultation with their child's physician or other mental health professional to develop an emergency action plan, called a “safety plan”. This is a planned set of actions for the family, youth and doctor to take if and when the youth has increased suicidal thinking. This should include access to a 24-hour hotline available to deal with crises. AACAP recommends that family members discuss this with the provider if they are uncertain about a black box warning.7" (emphasis mine) here

The claim that a 'recent review' was not conclusive has no citation---begging the question, what review is this conclusion supposedly based on?  Stating this claim immediately after sharing the fact there is a Black Box warning for SSRIs gives the impression that the Black Box warning is nothing more than a nuisance warning the AACAP is passing along, because they must. Stating that a recent review was 'not conclusive' immediately after sharing there is a FDA Black Box warning for suicide, in effect nullifies the FDA warning.  At the very least, the claim minimizes the importance of the warning.  The fact of the matter is, the increased risk of suicide is not the only risk identified in the FDA's Black Box warning on SSRIs; it is simply unethical for the AACAP to issue a document which minimizes a serious risk and fails to mention altogether the other behaviors identified in the warning.

via the FDA:
a couple of excerpts from the FDA's Black Box warning for SSRI antidepressants:
Revisions to Product Labeling
[These changes should be made to the box warning at the beginning of the package insert.]
DRUG NAME
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Insert Drug Name] is not approved for use in pediatric patients. [The previous sentence would be replaced with the sentence, below, for the following drugs: Prozac: Prozac is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD). Zoloft: Zoloft is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). Fluvoxamine: Fluvoxamine is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).] (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for [Insert Drug Name] should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.  (Emphasis: FDA original document) see here

via AACAP:
 Prescribing Psychoactive Medication for Children and Adolescents

Revised and approved by the Council on September 20, 2001
To be reviewed

Prescribing psychoactive medications for children and adolescents requires the judgement of a physician, such as a child and adolescent psychiatrist, with training and qualifications in the use of these medications in this age group. Certainly any consideration of such medication in a child or infant below the age of five should be very carefully evaluated by a clinician with special training and experience with this very young age group. Any child or adolescent for whom medication is a consideration requires an evaluation of the psychiatric disorder, including the symptoms, co-morbid conditions, any other medical conditions, family and psychosocial assessment and school record.

Most psychoactive medications prescribed for children under age 12 do not as yet have specific approval by the Federal Drug Administration (FDA); such approval requires research demonstration safety and efficacy. Such research, so far, lags behind the clinical use of these medications. Efforts to address this deficiency include the development of Research Units of Pediatric Psychopharmacology (RUPP) and recent federal regulations requiring increased studies of medications presented for children and adolescents. Long term studies are needed to adequately determine the safety and efficacy of psychoactive medications. In making decisions to prescribe such medications the physician - specifically the child and adolescent psychiatrist - should consider data from studies in adults in treating the target disorder and/or symptomatology, any clinical or anecdotal reports of use in child and adolescent patients, studies conducted outside the United States and the experience of colleagues.
(emphasis mine)

Anecdotally the prescribing of multiple psychotropic medications ("combined treatment"- "polypharmacy") in the pediatric population seems on the increase. Little data exist to support advantageous efficacy for drug combinations, used primarily to treat co-morbid conditions. The current clinical " state-of-the-art" supports judicious use of combined medications, keeping such use to clearly justifiable circumstances. Medication management requires the informed consent of the parents or legal guardians and must address benefits vs. risks, side effects and the potential for drug interactions.

It is important to balance the increasing market pressures for efficiency in psychiatric treatment with the need for sufficient time to thoughtfully, correctly, and adequately, assess the need for, and the response to medication treatment. Monitoring on-going use of psychoactive medications requires sufficient time to assess clinical response, side effects and to answer questions of the child and family. AACAP opposes the use of brief medication visits (e.g. 15-minute medication checks) as substitute for ongoing individualized treatment. The role of psychosocial interventions, including psychotherapy, must be evaluated, and such interventions must be included in the treatment plan. (emphasis mine)
This is a Policy Statement of the American Academy of Child and Adolescent Psychiatry here

Child psychiatrists seem to believe that anecdotal 'evidence' is a sufficient basis for prescribing teratogens with fatal risks; while minimizing the importance the risks of adverse events, including disability and death.

There is exactly one RUPP study listed on the Clinical Trials website:

Drug and Behavioral Therapy for Children With Pervasive Developmental Disorders here  So there is no effort to do the clinical trials that would  justify (or refute) the Standard unethical Practice of off label prescriptions. Psychiatrists are defending their "right to prescribe" teratogenic drugs without any empirical evidence of their therapeutic value, without evidence of their safety, and without being honest with patients or their parents about the risks for iatrogenic harm to children. It is the very definition of Human Experimentation without Informed Consent. Codifying off label prescribing as a Standard of Care, and a first line treatment; was based on consensus; this is not in reality an  'Evidence Based Practice,' it is dishonest and fraudulent to state that it is. A consensus is evidence of agreement, nothing more, just because off label prescribing is a common practice, does not make it an ethical or therapeutic practice, nor does it mean it is medically justifiable. Off label prescribing of psychotropic drugs is a common medical practice encouraged by psychiatry. Done without full disclosure of the experimental nature of off label drug treatment, precludes obtaining "Informed" Consent, for Human Experimentation has become an accepted psychiatric standard practice.  

via The Alliance for Human Research Protection:

Since May, 2008, the Institute for Safe Medication Practices, an independent nonprofit organization, has been monitoring FDA's MedWatch database, publishing quarterly reports (QuarterWatch ). The latest report found that in 2011, the FDA received 179,855 reports of serious, disabling, and fatal adverse drug events in the United States. This is an increase of 9.4% from 2010. In 2010 that number increased by 21% from 2009. Since 1998, the percentage increases of reported serious adverse drug events were in the double digits.

Most reports (88%) were submitted by pharmaceutical companies and they involve patent-protected drugs. Company reports about deaths were found to be “nearly useless” in that they are vague, failed to report critical patient information, such as cause of death or age of patient. Generic drug manufacturers rarely file adverse drug reports.

The authors—Thomas Moore, Curt Furberg, MD, PhD, and Michael Cohen, RPh, MS, ScD—point out that the most valuable barometer of drug safety risk is found in reports submitted directly to the FDA by physicians and patients. Unfortunately, the FDA estimates that serious adverse drug event reports submitted by physicians and patients constitute less than 1% of actual serious injuries. In 2011, physicians and patients submitted 21,002 adverse event reports to the FDA. These reports represent at least 2.5 million actual serious prescription drug injuries, including 128,000 deaths.

In 2011, the five leading drugs ranked by the number of direct adverse event reports from physicians or patients: anticoagulant drugs, Pradaxa and Coumadin linked to hemorrhage; antibiotic Levaquin linked to tendonitis, fatal allergic reaction, nerve damage resulting in pain, burning or numbness, and central nervous system abnormalities including depression, confusion; anti-cancer drug Carboplatin linked to bone marrow suppression; antihypertensive Lisinopril (Prinivil, Zestril) linked to dizziness, nausea, anxiety, insomnia, swelling, difficulty breathing.

The other valuable source of information documenting drug safety risk, are litigation-related adverse event reports submitted to the FDA. The five drugs most frequently cited in litigation were patent-protected: the anti-nausea drug metroclopramide linked to tardive dyskenisia; the contraceptive drugs Yaz and Yasmin linked to blood clots and stroke; the anti-diabetes drug Avandia linked to heart attacks; the anti-smoking drug Chantix linked to suicide and homicide; and the acne drug Accutane linked to suicide.

Fifty-eight drugs carry FDA-mandated warning labels about the risk of suicide and suicidal behaviors. The most frequently identified drug posing a suicide risk in 2011, was SEROQUEL, with 197 reported cases. Seroquel was first approved for schizophrenia and manic depression (bipolar) but is now widely used for a variety of approved and unapproved conditions, including depression and as a sleep aid. The second ranked drug that poses a serious risk of suicide is Chantix a drug approved as a smoking cessation aid--with 187 reported cases. Indeed, since its approval for marketing in 2006, Chantix has been identified in reports to the FDA as a high risk factor for suicide and homicide. Both of these drugs also pose serious cardiovascular risks. read the entire article here


I have yet to meet a parent who had been warned about risk of suicide, or the well-documented serious risks of any of the psychotropic drugs their children are prescribed---nor are they told the drugs are not approved for pediatric use or to treat the symptoms for which they are prescribed. The failure to warn is clearly common, just as it is common for professionals to minimize the risks and deny the harm done. None of the parents I am in touch with whose child experienced "agitation, irritability, unusual changes in behavior" immediately before taking their life had been warned.  Some were advised to increase the dose of the drug!  

While the AACAP's claim that the drug companies do not want to spend the money to have psychiatric drugs tested for safety and efficacy in order to gain FDA approval for pediatric use may be true; it is also true that the FDA also approves drugs on skeptical evidence and then does not require the drug companies to actually do the after-market clinical trials which are supposedly 'required' under  PDUFA, which also contributes to the lack of safety data available.  The fact that the AACAP and the American Psychiatric Association have not issued any position statements, and have not advocated for the correction needed in  either the approval process, and compliance with after-market research requirements, is less than ethical or honest, all things considered. The overwhelming risk of harm these two glaring failures represent for all psychiatric patients, should be a primary concern for both of these professional organizations; but are not even discussed. Psychiatrists could, by consensus institute a standard practice that requires psychiatrists to report adverse events patients experience when taking the psychiatric drugs prescribed to them. Doing so would serve the best interest of psychiatric patients.

I have no doubt whatsoever psychiatric patients' best interests are sacrificed by some psychiatrists altogether.  Whether it is due to inaccurate interpretations, misperceptions, innate biases, errors of attribution, hubris or malice really doesn't really matter.  All of these are reinforced by an obvious Conflict of Interest.  Academic psychiatry, the APA and the AACAP are dancing to the fiddler's tune and the pharmaceutical industry is fiddling away like mad...The illegally marketing of psychiatric drugs has been going on for decades; it is a massive ongoing criminal enterprise that would not have been so successful without the members of the APA and the AACAP being willing accomplices and co-conspirators; some are complicit by remaining silent, but complicit nonetheless. The silence is deafening to this MadMother.  The lawsuits and settlements have recouped a very small percentage of what has been stolen from the American people. The fraud continues unabated and the membership of the APA and the AACAP continue to be willing participants denying their culpability; while failing to discredit the criminal behavior of academic researchers, pharma whores, and clinical practitioners; sacrificing their integrity along with their patient's lives.  

Instead, these 'professional' groups issue policy statements which point to other institutions and other medical professionals as the cause of indiscriminate and widespread use of drugs  that have no evidence which supports their use...The fact remains, without psychiatric researchers, and psychiatrists acting as pharmaceutical marketeers akin to the snake oil salesmen of days gone by, We the People wouldn't have 'the problem' we are now faced with. Is it a reasonable expectation that a profession that continues to participate in a massive criminal enterprise and continues to deny any responsibility for the harm it has caused to millions of people, and society as a whole, will suddenly exhibit ethical integrity, and begin to serve the best interests of their patients? 


Washington State Law allows for adolescents to consent for their own Mental Health treatment at the age of 13; which means adolescents also have to give consent for   treatment information to be shared with parents/caretakers...how would any care taker know to watch for signs of adverse events if the Law excludes them from the treatment process?  I say this because in my personal experience, the age of consent law is used to exclude parents---it was used by Jon McClellan who claimed he had no duty to obtain my Informed Consent to treat my son at CSTC.  This blatant lie was  repeatedly proffered as a justification for his ethical and legal failures while he was "treating" my son without consent in spite of my vehement protests.  Imagine, knowing that Washington State Administrative Code applicable to children who are in the custody of the State of Washington required my Informed Consent, or a Court appointed advocate to give consent;  Federal Medicaid and Child Welfare Law also required Informed Consent from a parent, as does the National Institute of Health, and the Health and Human Services Office of Human Research Protection.  When I brought my son home severely impaired by the unethical treatment illegally "provided" by Jon McClellan, two psychiatrists in the two Community Mental Health Clinics with psychiatrists on staff also used the age of consent as a justification for ignoring my concerns altogether; both claimed they needed no consent from a parent, and even claimed my brain damaged son was the not complaining so there was no need to discuss the harm the drugs were causing...  Both of these 'doctors' claimed as McClellan had, that I had no say since Isaac was over the age of 13.  Both refused to even discuss the obvious ongoing harm being done to my son's overall health and well-being. 

These adverse effects are actual diseases which psychiatrists refuse to medically treat, and refuse to  make appropriate referrals to the medical professionals who do treat them.  My son has profound iatrogenic, i.e. physician caused, neurological and cognitive impairments; he has been profoundly disabled since before his 14th birthday. It is  utterly horrifying to know there is not a single ethical psychiatrist in the Community Mental Health system in this county, or the next; not that I am aware of any way...  I am outraged that I am not  listened to; but what is killing me is that fact that it is not me who these so called doctors are consistently failing; it is not to me that they owe an ethical duty to.  

Since before my son was born, it has been a Federal mandate that federally funded mental health and social services are to be, "client directed," in the case of child, to be child-centered and family-directed.  Indeed, the Mental Health Transformation Grants such as the Children's Mental Health Initiative, Systems of Care grant that Yakima County received is in all reality, a program in which the Federal Government is paying Yakima County and it's federally funded  child serving systems to come into compliance with Federal Regulations that are decades old; to stop committing fraud, and stop failing our community's children.  It is an additional insult that I have been aware for almost twenty years now that I have had to fight incompetent public servants; instead of being able to access the care my my son needed for his traumatic injuries.  Instead I was robbed of my parental rights without cause, and forced to bear witness to felony crimes being committed that further traumatizing and ultimately disabled my son.  These Federal Regulations  were instituted before Isaac was born and were instituted to prevent exactly the sort of mistreatment and the Medicaid fraud that paid for his mistreatment.  Federally funded social service and mental health programs are to be client-centered and family driven. Which means in all reality that not only was the manner in which my son was mistreated actually criminal and inhumane; the professionals responsible for the gross mistakes made committed Child Welfare and Medicaid Fraud robbing ALL of US in order to pay for it---Well over a million dollars was defrauded from federal programs in order to pay for crippling my once brilliant son.  I can not describe in polite terms what it is like to have unethical 'professionals' to this day insist that I need to respect their authority, and tell me I need to, "just get over it."  I can barely contain myself when these 'professionals' imply that I should be grateful, because after all, the help they provided cost a lot of money...The fact that these so called professionals stole the money from all of my neighbors and my extended family in order to pay for the harm they caused my son under the guise of providing 'help' is contemptible. 

Contempt is like respect, it must be earned. 

Evidence for the Neurotoxicity of Antipsychotic Drugs This is an Affidavit that conforms to the Rules of Evidence used in Courts of Law---it is derived from actual research data

TEOSS Drug Trials 

Double Blind... 

 an excerpt:

Acknowledgments

This study was supported by NIMH grants MH-61355 (Dr. Findling) to Case Western Reserve University, MH-61464 (Dr. McClellan) to the University of Washington, MH-62726 (Dr. Frazier) to Harvard Medical School, and MH-61528 (Dr. Sikich) to the University of North Carolina. Drs. Sikich (K23 MH- 01802) and Hlastala (K23 MH70570) were also supported by NIH career development awards. The research was conducted in NIH supported Clinical Research Centers at Seattle Children’s Hospital, University of Washington (M01-RR-00037) and at the University of North Carolina at Chapel Hill (M01-RR00046 and U54RR024383). 

Why were investigators at four sites funded when only two sites conducted the clinical trials?

Another strange thing about this five year trial, is the discrepancy in the number of children enrolled. Some reports say 119, others 116; and incredibly, some have both figures. Some data may be open to interpretation, or imprecise, however, the number of children enrolled in a $35 million dollar seeding trial conducted with the hope of gathering evidence to support FDA approval for pediatric use of the neuroleptics trialed, is not one of them.

Conflicts of Interest are Real

The following is from the Alliance for Human Research Protection, whose mission statement on their website states:

"The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected" 

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 expansionclinical 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

Here is another Report from 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

It is obvious to me the informed consent guidelines for foster kids in Washington State primarily protect the State of Washington; not the children in State care.  Let's be real, who in their right mind would believe that it is in the "best interests" of the children and teenagers in Washington State to lower the legal age of consent for psychiatric treatment to thirteen?  Human's brains are not fully fully mature,until we are in our early 20's. Couple this reality with the dishonesty, abuse of authority and of "Medical" privilege that psychiatry is known to rely upon in standard clinical practice; we have in effect, "legally" placed kids in harm's way.