AACAP Guidelines and Advocacy for Community-Based Systems of Care

first posted November 28, 2012 updated August 9, 2013
The AACAP is intentionally undermining the FDA 
black box warning on SSRIs:

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

"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)

Community-Based Systems of Care

Clinicians who serve children and adolescents with complex mental health needs generally find themselves interfacing with multiple child-serving systems and community programs, including juvenile justice, child welfare, substance abuse, developmental disabilities, and schools. AACAP advocates for the improvement of services in each of the systems to ensure children have access to a full array of prevention, early intervention, and treatment options.

To learn more about AACAP's clinical practice resources for community-based systems of care, click here.

Funding for Community-Based Systems of Care
Through the annual federal appropriations process, AACAP advocates for increased funding for federal agencies and laws that support state and community mental health treatment and services.
AACAP Policy Summary on FY 2013 Appropriations

Foster Care
A December 2011 report from the Government Accountability Office report discusses the use of psychotropic medications with children in foster care. The report highlights AACAP's Position Statement on Oversight of Psychotropic Medication Use for Children in State Custody: A Best Principles Guideline as the basis to assess states psychotropic drug monitoring programs for children in foster care. As a result, many states are adopting AACAP guidelines as they develop oversight systems.

Government Accountability Office Report:
Foster Children: HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions 

AACAP Position Statement on Oversight of Psychotropic Medication Use 

for Children in State Custody: A Best Principles Guideline 

Background 

Children in state custody (definition of state custody: the state has assumed all parental responsibilities and decision-making for the child) often have biological, psychological, and social risk factors that predispose them to emotional and behavioral disturbances.  These risk factors can include genetic predisposition, in utero exposure to substances of abuse, medical illnesses, cognitive deficits, a history of abuse and neglect, disrupted attachments, and multiple placements.

Resources for assessing and treating these children are often lacking.  Due to multiple placements, medical and psychiatric care is frequently fragmented.  These factors present profound challenges to providing high quality mental health care to this unique population.  Unlike mentally ill children from intact families, these children often have no consistent interested party to provide informed consent for their treatment, to coordinate treatment planning and clinical care, or to provide longitudinal oversight of their treatment.  The
state has a duty to perform this protective role for children in state custody.  However, the state must also take care not to reduce access to needed and appropriate services.

Many children in state custody benefit from psychotropic medications as part of a comprehensive mental health treatment plan. However, as a result of several highly publicized cases of questionable inappropriate prescribing, treating youth in state custody with psychopharmacological agents has come under increasingly intense scrutiny.  Consequently, many states have implemented consent, authorization, and monitoring procedures for the use of psychotropic medications for children in state custody.  These policies often have unintended consequences such as delaying provision of or reducing access to necessary medical care.

Basic Principles 

 The AACAP is the organization representing professionals most skilled in the art and science of child psychopharmacology.  Accordingly, the AACAP has developed the following basic principles regarding the psychiatric and pharmacologic treatment of children in state custody:
1. Every youth in state custody should be screened and monitored for emotional and/or behavioral disorders.  Youth with apparent emotional disturbances should have a comprehensive psychiatric evaluation.  If indicated, a biopsychosocial treatment plan should be developed.
2. Youth in state custody who require mental health services are entitled to continuity of care, effective case management, and longitudinal treatment planning.
3. Youth in state custody should have access to effective psychosocial, psychotherapeutic, and behavioral treatments, and, when indicated, pharmacotherapy.
4. Psychiatric treatment of children and adolescents requires a rational consent procedure. This is a two-staged process involving informed consent provided by a person or agency authorized by the state to act in loco parentis and assent from the youth.
5. Effective medication management requires careful identification of target symptoms at baseline, monitoring response to treatment, and screening for adverse effects.
6. States developing authorization and monitoring procedures for the use of psychotropic medications for youth in state custody should use the principles in this document as a guide and should assure that children and adolescents in state custody get the pharmacological treatment they need in a timely manner.

Best Principles Guideline 

 For states planning to develop programs for monitoring pharmacotherapy for youth in state custody with severe emotional disturbances, the AACAP proposes the following guidelines. Guidelines are categorized into minimal, recommended, and ideal standards.

1. State child welfare agencies, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications, in consultation with child and adolescent psychiatrists, should establish policies and procedures to guide the psychotropic medication management of youth in state custody.
States should:
a) Identify the parties empowered to consent for treatment for youth in state custody in a timely fashion [minimal].
b) Establish a mechanism to obtain assent for psychotropic medication management from minors when possible [minimal].
c) Obtain simply written psychoeducational materials and medication information sheets to facilitate the consent process [recommended].
d) Establish training requirements for child welfare, court personnel and/or foster parents to help them become more effective advocates for children and adolescents in their custody [ideal]. This training should include the names and indications for use of commonly prescribed psychotropic medications, monitoring for medication effectiveness and side effects, and maintaining medication logs.

Materials for this training should include a written “Guide to Psychotropic Medications” that includes many of the basic guidelines reviewed in the psychotropic medication training curriculum.

2. State child welfare agencies, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications, in consultation with child and adolescent psychiatrist, should design and implement effective oversight procedures that:
a) Establish guidelines for the use of psychotropic medications for youth in state custody [minimal].
b) Establish a program, administered by child and adolescent psychiatrists, to oversee the utilization of medications for youth in state custody [ideal].

This program would: 

i. Establish an advisory committee (composed of agency and community child and adolescent psychiatrists, pediatricians, other mental health providers, consulting clinical pharmacists, family advocates or parents,
and state child advocates) to oversee a medication formulary and provide medication monitoring guidelines to practitioners who treat children in the child welfare system.
ii. Monitor the rate and types of psychotropic medication usage and the rate of adverse reactions among youth in state custody.
iii. Establish a process to review non-standard, unusual, and/or experimental psychiatric interventions with children who are in state custody.
iv. Collect and analyze data and make quarterly reports to the state or county child welfare agency regarding the rates and types of psychotropic medication use.  Make this data available to clinicians in the state to improve the quality of care provided.
c) Maintain an ongoing record of diagnoses, height and weight, allergies, medical history, ongoing medical problem list, psychotropic medications, and adverse medication reactions that are easily available to treating clinicians 24 hours a day [recommended].

3. State child welfare agencies, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications, should design a consultation program administered by child and adolescent psychiatrists [recommended].

The consultation program:

a) Provides consultation by child and adolescent psychiatrists to the persons or agency that is responsible for consenting for treatment with psychotropic medications.
b) Provides consultations by child and adolescent psychiatrists to, and at the request of, physicians treating this difficult patient population.
c) Conducts face-to-face evaluations of youth by child and adolescent psychiatrists at the request of the child welfare agency, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications when concerns have been raised about the pharmacological regimen.
4. State child welfare agencies, the juvenile court, or other state or county agencies empowered by law to consent for treatment with psychotropic medications, should create a website to provide ready access for clinicians, foster parents, and other caregivers to pertinent policies and procedures governing psychotropic medication management, psychoeducational materials about psychotropic medications, consent forms, adverse effect rating forms, reports on prescription patterns for psychotropic medications, and links to helpful, accurate, and ethical websites about child and adolescent psychiatric diagnoses and psychotropic medications [ideal]  (emphasis mine)

AACAP "plan" is not in children's best interest

My primary problem with how the Academy is addressing the off label drugging of vulnerable children, is the lack of individual and collective responsibility and the lack of ethical integrity the AACAP demonstrates by failing to hold it's members accountable. There is no acknowledgement, or even a mention of the corrupt psychiatrists, the academic researchers, and "Key Opinion Leaders" whose corrupt work products laid the foundation to market psychiatric diagnoses and teratogenic drugs as effective "medical treatment" for children and adolescents with emotional and behavioral difficulties without evidence the drugs were safe or effective for children and adolescents.

It's as if we are supposed to pretend there is no connection between psychiatrists collaborating with the pharmaceutical industry on research, CME, symposiums and the AACAP's annual convention and the proliferation of off label prescriptions of psychotropic drugs to children? Exaggerated claims about safety, efficacy and effectiveness of psychotropic drugs were made by psychiatrists who were never censured or discredited for making fraudulent claims; nor has any of their corrupt work product been removed from the evidence base, or retracted from professional journals.  No psychiatrist has ever been held accountable for functioning as a marketeer for the pharmaceutical industry. What kind of distorted "medical judgement" causes a professional to use corrupt information to formulate treatment guidelines for using teratogenic drugs on children with emotional and behavioral problems without evidence of safety and effectiveness? It's unethical to recommend the use of dangerous drugs with serious and even fatal risks as a "safe and effective" way to "treat" the emotional and behavioral problems of vulnerable children. 

It is a relatively small number of individual psychiatrists whose unethical behavior propelled this criminal enterprise while the majority were merely complicit in their silence. Unethical  professionals were aided and abetted by their colleagues who continue to refuse to repudiate blatantly unethical conduct and unsafe treatment standards based on marketing strategies.

In all reality, a pharmaceutical marketing agenda permeates psychiatry's consensus based diagnostic criteria and standard treatment proocolss. Many psychiatrists are willfully blind to the iatrogenic injuries they inflict upon patients. Akisthesia, Tardive Dyskinesia, diabetes, obesity, high cholesterol, heart disease, and brain damage are characterized as  "acceptable risks," "tolerable side-effects," or worse, attributed to the psychiatric diagnosis the patient was given, if even recognized at all. The primary beneficiaries of this standard of care are the pharmaceutical companies and their stockholders. It's criminal; it violates the Human Rights of their minor patients and their parents.

Professionals with ethical integrity, critical thinking skills and without conflicts of interest would not be "monitoring" the use of fraudulent consensus based treatment algorithms/marketing agenda, but would rely on ethical medical research data and use ethical medical standards.

Why would any reasonable person believe that a group with a history of dishonest, unethical behavior can critically assess and correct long-term ethical failures? To date, there has not been a good faith effort to stop using corrupt research data, or retract phony 'peer-reviewed' journal articles; let alone stop using stop using unethical standards of care derived from corrupt research, or entirely based on consensus...There is no way the medical malfeasance will be stopped by the same psychiatric professional groups that have implemented, condoned and supported it--- It is insulting all things considered, are we are seriously expected to believe that monitoring the ongoing off label use of dangerous teratogenic drugs on vulnerable children is a good faith effort to first do no harm, much less, in any child's "best interest?!" Forgive me, but since when have we, as a society, entrusted criminals to stop their criminal behaviors and to police themselves?

The AACAP recommends that "State child welfare agencies, the juvenile court, or other state or county agencies...create a website" with links to "helpful, accurate, and ethical websites about child and adolescent psychiatric diagnoses and psychotropic medications" is in effect, recommending that other child serving agencies to do what the AACAP has utterly failed to do. What is truly needed is for these professionals to make actual, meaningful amends for their own egregious ethical failures.

It is time for psychiatrists to demonstrate to the world they are professionals worthy of being granted an opportunity to regain the trust they have shattered. Denying responsibility and failing to be accountable for what individual psychiatrists and professional groups have done to lose the public's trust only further undermines the potential for regaining it! Psychiatric professional groups must find the courage to hold individual psychiatrists who violate ethical research standards and who fail to obtain informed consent for treatment, and use unethical medical practices, accountable; instead of remaining silently complicit. 

I doubt the writers of this Best Principles guideline stopped to consider that one of their suggestions would require that referrals for information to the National Institutes of Mental Health, National Alliance on Mental Illness,  the American Psychiatric Association, and the American Academy of Child and Adolescent Psychiatry would need to stop since all of their websites have biased, inaccurate information about psychiatric diagnoses and psychotropic drugs for the general public.  It would be a meaningful gesture for the AACAP to lead the way and remove the biased and inaccurate information from it's own website replacing it with accurate, and ethical information as this Position Statement and Best Principles Guideline recommends...

Doctors who value integrity and honor their primary ethical duty, i.e. serving the "best interests" of their patients, would not turn a blind eye to unethical conduct; or continue to use standards developed from tainted research.

It takes humility and fortitude to be accountable. Trust is earned; it's not issued with a medical license!

Antipsychotic Medication Use in Medicaid Children and Adolescents: Report and Resource Guide From a 16-State Study 


photo from Just Ducks

Children being medicated for behavioral problems is a moral issue

Marianna, Kahlil's Sister. Painting by Kahlil Gibran

Kahlil Gibran             

On Children

Your children are not your children.

They are the sons and daughters of 

Life's longing for itself.

They come through you but not from you,

And though they are with you yet they belong not to you.

You may give them your love but not your thoughts,

For they have their own thoughts.

You may house their bodies but not their souls,

For their souls dwell in the house of tomorrow,

which you cannot visit, not even in your dreams.

You may strive to be like them,

but seek not to make them like you.

For life goes not backward nor tarries with yesterday.

You are the bows from which your children

as living arrows are sent forth.

The archer sees the mark upon the path of the infinite,

and He bends you with His might

that His arrows may go swift and far.

Let your bending in the archer's hand be for gladness;

For even as He loves the arrow that flies,

so He loves also the bow that is stable.

The proliferation of psychotropic drugs prescribed to alter children's behavior, is something that must be drastically reduced, at the very least.  Karim aptly calls this practice, "meducating our children," in a recent article on Somatosphere about children without ADD or ADHD who are being prescribed amphetamines to enhance school performance. It is deeply disturbing how carelessly teratogenic drugs that have harmful adverse effects are being used. Even worse, the right to prescribe the drugs off label is being vehemently defended by psychiatrists. Apparently, defending a right that is being abused with impunity is more important than helping those patients who are harmed or calling for a stop to off label prescriptions which are not supported with empirical data, drugs prescribed for no valid medical reason.  If patients and the ethical prescribing practices are important, they are obviously not as important as maintaining the illusion of psychiatry, i.e. the drugs effectively and safely treat symptoms of whatever psychiatric diagnosis they have been given, if they have been given a diagnosis... 

Most of the off label prescriptions for poor children on Medicaid and are paid for illegally by fraudulently billing the cost of the drugs to Medicaid. It is an ongoing fraud, that no one, (that I know of) except for Jim Gottstein, of the Law Project for Psychiatric Rights has put any effort into stopping. The American taxpayers are footing the bill for drugs being prescribed off label, i.e. a non-FDA approved, to poor children on Medicaid. In reality, when there is no ethically valid medical reason for the prescription to be written, it is not medical treatment; it is unethical medical experimentation.  

It is simply immoral.

via Jim Gottstein:

The online program to learn about psychotropic drugs for people who work with children Critical Think Rx, at the School of Social Work at Florida International University: here.

via Somatosphere
Meducating Our Children: The Moral Influence of Adderall on Education, Parenting, and Treatment
By Tazin Karim

"Allan Schwarz’s recent New York Times article “Attention Disorder or Not, Pills to Help in School” presented some controversial testimonials on the prescription of attention deficit and hyperactivity (ADHD) medications to low-income children. As science writer Emily Willingham points out, this article is part of a two decade long debate over the merits of medicating our nation’s children..." read here.

Somatosphere on twitter

Tazin Karim on twitter

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.

Drugging Our Children: Legal and Moral Issues

via Jim Gottstein, founder of Psychrights

Are Psychotropic Drugs Safe and Effective and the Best Choice?

From Psychiatric drugs and common factors: An evaluation of the risks and benefits for clinical practice

a couple of excerpts:
"Finally, consider the NIMH funded Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) (McClellan et al., 2007). This landmark trial, initially compared in scope to the MTA and TADS, sought to examine the efficacy, tolerability, and safety of two SGAs (Risperdal and Zyprexa) for youths diagnosed with early-onset schizophrenia spectrum disorder and to compare these to a FGA (molindone or Moban). Of the 119 participants, 41% withdrew either as a result of adverse effects or inadequate efficacy. A 17-year old boy committed suicide and an unspecified number of participants were hospitalized due to suicidality or worsening psychosis. These events are particularly disturbing in light of the fact that youths considered at
risk for suicide were excluded from the study. Weight gain (not specified) was deemed serious enough to warrant suspension of the Zyprexa arm. By 2007, reports on TEOSS are scant. The NIMH does not describe this study on its website, nor list it as an on-going or completed trial.  No published reports for those responders who continued into the 44-week phase are available."

"Pharmacotherapy helps some children and adolescents. However, the preponderance of empirical research indicates that the risk may not be worth it. The Working Group asked: “how many children should benefit from an antidepressant to justify one extra child harmed. . .?” (Working Group, 2006, p. 114). They further noted that, despite evidence for all ADHD treatments, the data indicate that the benefits of medication do not maintain over time and the long term adverse effects are unstudied and unknown. Given this, the group determined that “with regard to use over a period of 2 to 3 years, “the risk–benefit analysis of stimulant medication does not appear to be favorable because beneficial effects appear to dissipate while side effects (e.g., growth) do not” (p. 52, italics added).

The Working Group’s report omitted the controversy surrounding the risks for adverse cardiovascular events and mania associated with ADHD drugs (the report was in press before the FDA’s analysis). Adding this into the equation, confidence in stimulants as best practice for childhood behavior problems further erodes, tilting the risk/benefit analysis toward more risk free behavioral interventions. While pharmacotherapy involves considerable risk for young people, psychosocial interventions have a strong track record with virtually no adverse associated medical events (Working Group, 2006), prompting the authors to conclude: For most of the disorders reviewed herein, there are psychosocial treatments that are solidly grounded in empirical support as stand-alone treatments. Moreover, the preponderance of available evidence indicates that psychosocial treatments are safer than psychoactive medications. Thus, it is our recommendation that in most cases, psychosocial interventions be considered first. (p. 16. Italics added)

"In sum, the automatic prescription of psychotropic medications for adults and children, based on known risks and equivocal efficacy, is unwarranted. Where children are concerned, the stakes are higher. They are, essentially, mandated clients—most do not have a voice to say no to treatments or devise their own, and depend on adults to safeguard their wellbeing (Sparks & Duncan, in press). Clients, caretakers, and practitioners need to discern science from spin to arrive at an informed analysis of the evidence."

My thoughts about the lack of published results of the NIMH TEOSS drug trials:
The only reason I can think of for the failure to publish: there is no perceived financial/social/academic benefit to the research psychiatrists, and no perceived financial gain for the drug companies.  There would be no professional accolades or media attention bestowed on the research psychiatrists which would then lead to other grant opportunities.   There is no benefit conferred upon the research psychiatrists, in publishing the abysmal results---The point of the research, is to add to the evidence base for the American people's benefit;  not to confer academic, or celebrity status upon the researchers!

All data is important to an Evidence Base---The data from these publicly funded Drug Trials, indeed, the data from ALL publicly funded drug trials, belongs to the American people who paid for the trials to be conducted, and should be available and readily accessible to the us.  When data from publicly funded research it is not available; the American people have in effect, paid for something which we do not actually receive.  The data belongs to the American people not the to NIMH, the FDA or the research psychiatrists who conduct and some are now known to have committed fraud, burying undesirable results, and publishing pseudo-results with the intent to cause doctors to prescribe a particular drug!   The newer and more expensive, (not necessarily safer or more effective) drugs are invariably touted as better and recommended to be used first---The neuroleptic drugs trialed in TEOSS have since been approved by the FDA for use in children, it is a mystery exactly what the FDA's approval was based on.  The Evidence Base for these drugs used on adults, IMHO, precludes (or should have) all but very limited use in children!

I am doubtful that my son was not part of the TEOSS--the drugs he was given were the very ones Dr. Jackass and his co-conspirators were using.  I suspect that he may have later been enrolled in a long-term Clozapine trial---another Federally funded drug trial using adolescents as participants...No consent, no compassion, no choice, no justice---to date.  These drugs were prescribed without being adequatedly, i.e. truthfully informed.  Indeed, I was repeatedly told by Dr. Jackass, Jon McClellan that I had no say at all.  The now widespread use of these teratogens for virtually all of the most common psychiatric diagnoses is occurring without the children who take them, or their guardians / caretakers, being given adequate information in order to give an Informed Consent.  The real risks are well documented; neuroleptic drugs can have a profound adverse effect on the parasympathetic nervous system, e.g. which is why the drugs can cause cardiovascular, metabolic and endocrine systems to become chronically dysfunctional, resulting in conditions like diabetes, obesity, and heart disease.

Diabetes and heart disease are among the top ten leading causes for premature death in the U.S. and both of these conditions have become more prevalent at the same time these drugs were being crammed down the throats of those seeking help for emotional distress, and cognitive/behavioral issues. Indeed, some of the psychiatric drugs makers have been fined heavily for burying research results which identified these harmful effects---some of these drugs were approved by the FDA based on corrupt and incomplete information.  None of the psychiatric drugs that FDA approval was granted based upon incomplete, biased or otherwise  corrupt data; have had to undergo any further review by the FDA

While psychiatric drugs do, in fact help some people who take them, a very significant percentage--are not helped; some of these people find that even though the drugs do not help them, they are dependent upon them--or worse, forced to take them under court order.  The dependence is not unusual and is well documented in the literature.  There are musts, in my opinion.  People must be informed (the informing and consent to drug treatments should be an ongoing dialog!) free of manipulation of facts or abuse of real or perceived authority the professional has!  The risks for dependence, drug-induced neurological damage, chronic physical illnesses and death are risks which obviously need to be shared and discussed openly and honestly.

In my experience, not only are they not discussed openly, they are denied, or if acknowledged, deemed to not be relevant!  These risks have never been openly discussed with me or my son by any psychiatrist who has "treated" him.   In fact, when any of the risks or "side-effects" were brought up by either of us, my son's complaints and distress and my concerns were dismissed, minimized, or denied altogether---our concerns were irrelevant to every psychiatrist who has treated him for over a decade.

The Mental Health Transformation is about transparency, evidenced-based treatments and services, client and family directed care.  My experiences over the last 18+ years of accessing mental health services in the publicly funded system have often been traumatizing for my family; and has ultimately altered the course of our individual day to day lives.

It is obvious that children and families need to be helped, and it should be equally obvious that the help can not ethically be based on inaccurate information and deceptive practices.  Coercion and manipulation, to gain psychiatric drug "treatment compliance" is dishonest; not therapeutic in our experience.  When seeking Court Orders for Involuntary Treatment, the spirit and the letter of the law should be followed.  Rules of Evidence and Standard Court Procedures, attorneys that actually represent and defend their clients needs to be provided.  It is not acceptable to lie about any person or event, or to attest to things that the attestor does not know "first hand" to be true -- doing so is perjury.

My family knows from experience when the legal procedures are not followed in the obtaining of Involuntary Treatment Court Orders in Yakima County Washington.   Felony crimes committed by a psychiatrist and Designated Mental Health Professional were reported, but not investigated.  This is what passes for "client and family directed" mental health care at Central Washington Comprehensive Mental Health.

A diagnosis of "mental illness" is not the same as a diagnosis of any other illness---I am so sure of this fact...

Read Psychiatric drugs and common factors: An evaluation of the risks and benefits for clinical practice here.