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

Bridge of Sighs

Mothers are the necessity of invention.

Bill Watterson

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

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

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

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

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

1 Boring Old Man

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

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

A MadMother

Washington State hired an architect of the TMAP fraud

update 11-21-2012

via PROPUBLICA Dollars for Docs:

       Chiles, John A. Tacoma Wash. Johnson & Johnson 2010 Q1-Q4 Speaking $7,150
Chiles, John A. Tacoma Wash. Johnson & Johnson 2010 Q1-Q4 Meals $262
Chiles, John A. Tacoma Wash. Johnson & Johnson 2010 Q1-Q4 Travel $742

Payments for speaking, travel and meals from Janssen Pharmaceuticals, Inc. (formerly OMJPI) a subsidiary of Johnson and Johnson

John A Chiles, M.D., one of the authors of the Texas Medication Algorithm Project, or TMAP, was hired by Washington State in 2008. This man is an one of the architects of a program that was an intrinsic component of one of the largest cases of Medicaid fraud in US history. Washington State gave him employment and placed him in multiple positions of authority years AFTER the State of Texas had joined in a whistleblower lawsuit in December of 2006, alleging, "TMAP was just one part of an elaborate marketing scheme to increase psychotropic drug sales." here

The authors of TMAP claimed that it was an evidence-based treatment protocol; with only the newest most expensive neuroleptic and other psychotropic drugs listed as preferred "first-line" treatments. These newer, much more expensive drugs became the only drugs Texas allowed Medicaid providers and State correctional facilities to prescribe patients. John A. Chiles, M.D. is the author of the schizophrenia algorithm used in the TMAP marketing plan; as such, he claimed that the newer neuroleptic drugs, or second-generation antipsychotics,  SGA drugs, were safer and more effective than the older inexpensive drugs used to treat schizophrenia.  


This news segment from KXAN in Austin Texas reports that John Chiles was paid $151,254.73 by Janssen the makers of Risperdal while working on the TMAP algorithms.

Drug firms paid 'independent' experts: kxan.com

via Pharmalot: December 5, 2008 "The common distinction between first- and second-generation antipsychotics has no scientific basis and should be dropped, according to a paper in The Lancet. A meta-analysis of 150 double-blind studies found little evidence that newer, so-called atypical antipsychotics are more effective than older drugs for symptoms of schizophrenia, MedPage Today writes. "The researchers also found that, although newer drugs induced fewer extrapyramidal effects (including tremor, slurred speech, restlessness, movement disorders, among other things) than Haldol, which is also known as haloperidol, this did not occur when compared with low-potency first-generation agents. "In an accompanying editorial, two British researchers went further, calling the notion that newer agents are more effective or safer than older drugs “spurious.” “As a group they are no more efficacious, do not improve specific symptoms, have no clearly different side-effect profiles than the first-generation antipsychotics, and are less cost effective,” wrote Peter Tyrer of Imperial College in London and Tim Kendall of the National Collaborating Centre for Mental Health in London." here NOTE: the study published in the Lancet was funded by NIMH, conducted by US researchers, but was not published in the US, and no press release was issued by NIMH.
Why would Washington State choose to employ a psychiatrist who is so unethical as to willingly participate in an obviously criminal enterprise that laid the foundation and became the means by which billions of dollars in Medicaid fraud was perpetrated? TMAP itself was fraudulently marketed as an "Evidence-Based" method of treating mental illnesses and it was implemented in multiple states, Washington State included. The fact that after the secret is out, Washington State hired one of the criminal psychiatrists who authored it, is stunning.
 

It appears that Washington State actually hired John A. Chiles to do for us what he did for Texas: According to the Washington Community Mental Health Council Administrative Services Division in 2008, "Dr. Chiles is currently Clinical Professor of Psychiatry at the University of Washington and consults with a variety of organizations on the implementation of evidenced-based treatment. As a member of that school’s Division of Public Behavioral Health and Justice Policy, he is helping to design evidenced-based mental health treatment programs for state mental health and corrections programs."

It is standard practice for psychiatrists with questionable ethics to be given awards from their peers:

via Washington State Psychiatric Association:
The Merlin Johnson Award is a lifetime achievement award for recognition of distinguished teaching and exemplary efficiency in clinical administration. Merlin Johnson was an exceptional administrator who was known for his intellectual curiosity, warmth, and humor He played a major contributory role in the development of the department of psychiatry at the Seattle Veteran's Administration; one of the largest and most innovative residency training programs in the nation. The Merlin Johnson award is given annually to an exemplary community psychiatrist in our state in honor of Dr. Johnson's leadership and dedication to WSPA and APA.  The 2010 Merlin Johnson Award was given to John Chiles, MD. here via the Washington Community Mental Health Council Administrative Services Division 2008 Fall Conference brochure: Special Thanks to our Sponsors: Gallagher Benefits, Inc., and Janssen Pharmaceuticals ~ Speakers and Board Members ~ ◈ Dr. John Chiles is one of the architects of the Schizophrenia Module of the Texas Medication Algorithm Project (TMAP). As Professor of Psychiatry at the University of Texas Health Science Center in San Antonio and Chief of Psychiatry Services for the University Health System, he helped design, implement, and evaluate this program, the largest outcome/cost study of the effects of evidence-based treatment of major mental illnesses yet done. TMAP algorithms are now required in all public sector clinics in Texas, and the schizophrenia module of TMAP is being implemented in approximately 20 other states. Dr Chiles has written over 70 articles, book chapters,  and  books.  In  addition  to  his  work  with schizophrenia, he has written extensively on the management of suicidal behavior. Dr. Chiles is currently Clinical Professor of Psychiatry at the University of Washington and consults with a variety of organizations on the implementation of evidenced-based treatment. As a member of that school’s Division of Public Behavioral Health and Justice Policy, he is helping to design evidenced-based mental health treatment programs for state mental health and corrections programs. here

BIOGRAPHIC STATEMENT 

JOHN A CHILES MD 

Dr. Chiles obtained his medical degree from the University of Pennsylvania in 1966, and did his post graduate training at the University of Wisconsin.  There, he studied with Leonard Stein and others during the time the concepts of intensive community support for the seriously mentally ill were being developed.  Dr. Chiles stayed one year on the faculty at Wisconsin, and then moved to Seattle to join the Department of psychiatry at the University of Washington.  His career there spanned 17 years, during which time he held various positions including director of the University Hospital Psychiatric inpatient services, director of Harborview Community Mental Health Center, and Chief of Psychiatry at Harborview Medical Center.  In 1990, Dr. Chiles accepted a position as Professor of Psychiatry at the University of Texas Health Science Center in San Antonio and Chief of Psychiatry Services for the University Health System.  While in Texas, he helped design, implement, and evaluate the Texas Medication Algorithm Project, the largest outcome/cost study of the effects of evidence-based treatment of major mental illnesses yet done.  TMAP algorithms are now required in all public sector clinics in Texas, and the Schizophrenia module of TMAP is in wide use both nationally and internationally. Dr. Chiles retired from the University of Texas in 2000.  He and his wife Judith returned to Washington State and live in Port Townsend.  Together, they formed Sound Psychiatry Consulting and work with a variety of private and public mental health systems concerning the implementation of evidenced based treatments for mental illnesses.  Between 2006 and 2008, Dr. Chiles served as Chair of the Board of Western State Hospital.  In 2008, Dr. Chiles rejoined the faculty at the University of Washington as Professor of Psychiatry and Behavioral Science, and is currently on contract with Western State Hospital, were he serves as Medical Director and on site faculty for the Washington Institute for Mental Health Research and Training.  Dr Chiles has written over 70 articles, book chapters, and books.  In addition to his work on illness management and Schizophrenia, he has written extensively on the understanding and treatment of suicidal behavior. The Chiles’ are co-owners of Two Coyote Vineyards in the Yakima Valley. Both are avid bicyclists and sometime golfers.  here

Who is the idiot that put the active participants in an ongoing criminal enterprise in charge of protecting the victims?

The author's relevant Conflicts of Interest:
I am biased.  My son is a Risperdal victim.  J&J started illegally marketing the drug as soon as it was FDA approved. All due respect to the Justice Department, the investigation going back to 2004, is not going back far enough. J&J had been illegally marketing Risperdal for close to a decade by 2004. The DOJ fines and penalties are very small % of the money that J&J defrauded from the American people through Medicaid and Medicare, and have not caused J&J to alter the unethical manner in which business is conducted. More importantly, these fines and penalties do not help J&J's PRIMARY VICTIMS who are grievously harmed. There is no way to compensate those who mourn the loss of a family member, the parents and children of J&J's victims who were killed by iatrogenic homicide. How can it ever rectify the harm done to Risperdal  victims who were further victimized because the adverse effects of Risperdal were attributed to the patient's  "psychiatric disease," or attributed to yet another psychiatric disease, which required adding a comorbid diagnosis?  It does nothing for the parents who are taking care of an adult child that is disabled like my son is? My son requires a great deal of assistance, and probably will for the rest of his life. Don't misunderstand me, it is an honor and a priveledge to take care of my son; but, it is also a tragic that it is even necessary.  

a screen shot from Sheller FDA Petition Comments

I am getting real tired of the "news reports" in the mainstream media which are about risk for diabetes and obesity from the neuroleptic drugs, called "antipsychotics." Children are being prescribed neuroleptic drugs for virtually any and every diagnosis---this is clearly Human Experimentation, occurring in Standard Clinical Practice; referring to it as "off label prescribing" implies that that there is some statistically relevant evidence which supports using these teratogenic drugs with fatal risks in the manner they are being used. The evidence does not even support using the drugs for the diagnosis of schizophrenia as a "first-line treatment," the condition for which the drugs were originally developed and prescribed for.

The very real risks of obesity and diabetes however are not, at least in my mind, what is most alarming about the fact that so many children are being prescribed neuroleptic drugs; nor is the fact that the American people are being defrauded through Medicaid (still!) in order to pay for these "off label" prescriptions over 90% of the time.  Nor is it that journalists are failing to ethically report on any of the issues involved with prescription drugs, with rare exception. The articles are often lost amongst the prescription drug advertising and the press releases journalists publish without verifying the veracity of any of the "facts" which the press releases contain...I accept that this is what is passes for "reporting the news."  There is very little reporting in the mainstream news about the rampant fraud in academic research, there is even less about the questionable (to say the very least) FDA approval process; this keeps people misinformed, dangerous drugs stay on the market, and keeps people are unaware of the risks involved when seeking psychiatric treatment. Once drugs are  FDA approved, the manufacturers rarely do the required after-market testing, and are never held accoutable for this failure.  There is little effort to no effort invested in regulating the marketing of FDA approved drugs so there are no meaningful consequences for making false claims in direct-to-consumer and direct-to-professional marketing of FDA approved drugs.  Apparently, the fact that people are being harmed at an alarming rate, is not "news," it is rarely reported. All of this is due to the unethical conduct of public servants with glaring conflicts of interest, which is also rarely if ever, reported by mainstream journalists.

Add to this obfuscation of the facts regarding psychiatric diagnoses and the toxic teratogens used to "treat" them, is the fact that adverse effects (including death) do not have to be reported to the FDA by medical professionals--If the FDA's primary purpose is to protect people from the risks of prescription drugs, adverse events and adverse effects is data that should be required reporting, it is needed order to effectively assess a drug's safety profile.  The FDA's primary purpose is not to protect the American people from the risks for harm, if it were, prescribers would be required to report adverse effects and adverse events. Protecting patients from harm is only a stated purpose; it is a marketing tool, a cover story. I don't believe protecting the American people was ever the FDA's primary purpose; it certainly is not a purpose that is effectively or ethically served currently.

The primary purpose served by the modern FDA is to protect the interests of the pharmaceutical industry. People who are given a psychiatric diagnosis are automatically at risk for experiencing grave harm because diagnostic criteria and treatment standards are developed by consensus; and consensus is regularly substituted for empirical data.  There are two reasons for this, the first reason is there is insufficient evidence, and the second reason is the evidence does not support the marketing agenda in which it is claimed drugs sagfely and effectively treat a diagnosis.  Psychiatry in this way ignores ethical scientific research standards; and it is abdicates it's responsibility for exercising sound, ethical medical judgement. It is a systematic way to standardize Human Experimentation on people who are given a psychiatric diagnosis in standard practice. The unethically developed "Standards of Care" become an affirmative defense for unethical medical practice, they are in this used by professionasl to abdicate any and all liability for harm to patients. Calling it a Standard of Care when it ignores ethical, scientific research and ethical medical practice standards is such utter BS---no one can possibly believe deception, fraud, and unethical behavior are necessary to provide mental health care. It is a way to rationalize, justify and codify unethical behavior; it serves to absolve doctors of liability for the grievous harm inflicted on patients using dangerous drug saccording to unethical standards.

In standard clinical mental health practice, there is no empirical data that is used to objectively diagnose a person. More often than not, there is no evidence that would support the recommended treatment.  The treatment is usually teratogenic drugs with fatal risks, and/or electroshock. The reality is there is very little science and a whole lot of consensus. Consensus is evidence of agreement; it is not evidence of diagnostic validity; it is not an ethical basis for a medical treatment, much less a basis to force a person, since it does have the serious risks of causing disability and death! Patients are at a serious disadvantage, as soon as a psychiatric diagnosis is attached. Rarely is the harm done to them reported. In my experience, as the mother of a child who was the victim of a violent assault, once a psychiatric diagnosis was attached, the harm done to my son, including felony crimes committed by "professionals," can be reported; but are never investigated.

Adverse reactions from drugs, (if even recognized as an adverse reaction) are attributed to the psychiatric "disease" the patient is diagnosed with. The way the mental health psychiatric system is set up, the direct adverse effect of diagnosis and treatment upon the patient is not relevant; negative effects are rarely acknowledged, if at all. These effects are purposely not being collected; consequently the harm cannot be quantified by those with an ethical duty to do so. Indeed, the people who have an ethical and a legal duty to, "First, do no harm..." are covering up the evidence that they are doing a great deal of harm to a great number of victims whom they call patients. The majority of these victims are poor children and foster children on Medicaid, the elderly on Medicare, and traumatized Veterans on Tri-Care. They all have one thing in common: they were seen as a means to an end. Their psychiatric stigmatization was the means and meeting the marketing goals of the pharmaceutical industry was the financially lucrative ends. these particular populations were targeted for diagnosis and treatment because they had medical benefits which would pay the costs of their "care." They were used because the American people had seen fit to ensure these vulnerable people had their medical needs provided for. Pharma's illegal marketing campaigns targeted those among us who are the most vulnerable, and least capable of effectively defending themselves to meet their marketing goals...Isn't that special?

Back to my original point, the things that are NOT being discussed are the serious adverse effects on sexual functioning that Risperdal and other psychotropic drugs have on human beings.  We are allowing children who are not sexually mature, to be given drugs which adversely effect normal sexual development and functioning; in effect, ensuring that many will never be capable of having a normal sexual relationship. If that is not a risk which should be of concern to their parents and the professionals who are alarmed about the diabetes and obesity risk, than I am Mary freaking Poppins! The rate children are being disabled and killed is not even MENTIONED by any of the "stake-holders" involved in the frantic efforts undertaken (supposedly on the behalf of foster children) when the THIRD Senate investigation was launched into the off label prescribing of teratogenic drugs to vulnerable children. The very people who we entrust to take care of our Nation's foster children do not appear to be concerned at all about how many of the children have been disabled and killed due to the direct negative effects of off label prescriptions taken as directed.  These are relevant facts which should be part of the discussion; however, they are in fact being ignored by the paid public servants in Child Welfare, Academic Researchers paid to do drug and psychiatric treatment research, grassroots advocates claiming to be the Nation's voice on mental illness, The American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry.

Well I am WIDE awake and I want to know why are the worst risks faced by these children for brain damage, sexual development, and sexual dysfunction, sudden death, and chronic neurological impairment are being ignored by those who are "concerned." The study below is over; as usual, results are not available...

But more than this, I want to know who is the idiot who thought putting active participants in an ongoing criminal enterprise, in charge of protecting their victims was a good idea? 

Clinical Trials.gov
An Observational Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children

This study has been completed.

Sponsor:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Information provided by:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

ClinicalTrials.gov Identifier:

NCT01050582

First received: January 14, 2010

Last updated: May 25, 2012

Last verified: May 2012

History of Changes

  Purpose

The purpose of this observational study is to evaluate risk of prolactin-related adverse events (side effects) and the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children exposed to these drugs

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders	Drug: Risperidone Drug: Other atypical antipsychotic drugs	Phase 4

Study Type:	Interventional
Official Title:	Evaluation of Growth, Sexual Maturation, and Prolactin-Related Adverse Events in the Pediatric Population Exposed to Atypical Antipsychotic Drugs

Resource links provided by NLM:

MedlinePlus related topics: Autism Bipolar Disorder Schizophrenia

Drug Information available for: Prolactin Risperidone

U.S. FDA Resources 

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

• To compare Z-scores for height, age at current Tanner stage, and prolactin-related adverse events between patients exposed to risperidone and patients exposed to other atypical antipsychotic drugs. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• Assess the prolactin value and risk of hyperprolactinemia associated with risperidone as compared with other atypical antipsychotic medications in a pediatric population. [ Time Frame: One time during the study visit ] [ Designated as safety issue: Yes ]
• Identification of subgroups of patients at high risk for changes in height or maturation. [ Time Frame: During the study visit and retrospectively during the time of exposure for up to 2 years prior to the study visit ] [ Designated as safety issue: No ]

Enrollment:	244
Study Start Date:	October 2009
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 001 Risperidone As per local prescribing practices	Drug: Risperidone As per local prescribing practices
No Intervention: 002 Other atypical antipsychotic drugs As per local prescribing practices	Drug: Other atypical antipsychotic drugs As per local prescribing practices

  Show Detailed Description

  Eligibility

Ages Eligible for Study:	8 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• One or both parents (according to local regulations) or a guardian must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study (If appropriate according to local regulations, the patient must also assent)
• Treated for schizophrenia, bipolar mania, autistic disorder, or conduct and other disruptive behavior disorders
• Had at least 6 months of exposure for an atypical antipsychotic drug within 24 months before the study visit (patients may or may not be taking the atypical antipsychotics at the time of actual enrollment, eligible patients can have exposure to multiple atypical antipsychotics, however, they cannot concomitantly be exposed to more than 1 atypical antipsychotic for a period of greater than 30 days)
• Had medical records or automated data available for at least 1 year prior to the start of exposure
• Height and weight were recorded at least once within 1 year before the start of exposure, and if available at any time points after the start of exposure in the medical records or electronic databases (not mandatory)

Exclusion Criteria:

• Have at least 1 medical record, at any time before the start of exposure, consistent with malignancy (other than non-melanoma skin cancer), pregnancy, or a developmental delay or abnormality associated with growth or sexual maturation delays not related to the specified indications
• Had exposure to prolactin elevating medications other than atypical antipsychotics and selective serotonin reuptake inhibitors (SSRIs)
• Had exposure to Paliperidone
• Cannot comply with study procedures

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050582

  Hide Study Locations

Locations

United States, California

San Francisco, California, United States

United States, Colorado

Aurora, Colorado, United States

United States, Florida

Altamonte Springs, Florida, United States

Gainesville, Florida, United States

United States, Georgia

Smyrna, Georgia, United States

United States, Illinois

Naperville, Illinois, United States

United States, Indiana

Indianapolis, Indiana, United States

Valparaiso, Indiana, United States

United States, Massachusetts

Boston, Massachusetts, United States

Cambridge, Massachusetts, United States

United States, New York

Glen Oaks, New York, United States

United States, Ohio

Cleveland, Ohio, United States

Columbus, Ohio, United States

Belgium

Antwerpen, Belgium

Germany

Freiburg, Germany

Jena, Germany

Mannheim, Germany

München, Germany

Tübingen, Germany

Ulm, Germany

Würzburg, Germany

Greece

Athens, Greece

Netherlands

Nijmegen, Netherlands

Poland

Gdansk, Poland

Kielce, Poland

Lódź, Poland

Sosnowiec, Poland

Warszawa, Poland

Warszawa N/A, Poland

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  More Information

No publications provided

Responsible Party:	Clinical Leader Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT01050582     History of Changes
Other Study ID Numbers:	CR016687
Study First Received:	January 14, 2010
Last Updated:	May 25, 2012
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Schizophrenia Bipolar Disorder Autistic Disorder Attention Deficit and Disruptive Behavior Disorders Risperidone

RISPERDAL Antipsychotic Agents Prolactin Pediatrics

Additional relevant MeSH terms:

Schizophrenia Child Development Disorders, Pervasive Schizophrenia and Disorders with Psychotic Features Autistic Disorder Mental Disorders Bipolar Disorder Attention Deficit and Disruptive Behavior Disorders Attention Deficit Disorder with Hyperactivity Mental Disorders Diagnosed in Childhood Affective Disorders, Psychotic Mood Disorders Antipsychotic Agents Risperidone

Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents

ClinicalTrials.gov processed this record on October 03, 2012

Washington State to get $4.6 million of the $181 million from J&J

What about the primary victims?

via seattlepi.com:

Johnson & Johnson subsidiary to pay record amount to settle off-label marketing charges for antipsychotic drugs

Posted by Rita R. Robison on August 30, 2012 at 5:40 pm

"Attorneys general in 37 states reached a record $181 million dollar settlement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. They allege that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega.

"The lawsuit charges that Janssen engaged in unfair and deceptive practices when it promoted the antipsychotic drugs for unapproved or off-label uses.

"Washington state will receive more than $4.6 million to be used for enforcement and grants that will benefit people who suffer from the conditions the drugs were illegally marketed for, Washington State Attorney General Rob McKenna said in a statement" Rita R. Robison

No offense to Ms. Robison, but the alarm on my detector is shrieking...

Ms. Robison posted this comment to her article:

"These drugs, which have serious side effects, were market(sic) for treating kids and seniors, although the drug company had no evidence the drugs were effective for these age groups." 

via Seattle Times:

Originally published Thursday, August 30, 2012 at 3:02 PM

Business Highlights
NY AG: Janssen pays $181M over drug marketing

"ALBANY, N.Y. (AP) - Janssen Pharmaceuticals Inc. and parent company Johnson & Johnson on Thursday announced a $181 million settlement with 36 states and the District of Columbia over charges of marketing anti-psychotic drugs for non-approved uses.

"New York Attorney General Eric Schneiderman, representing one of the states involved, claimed in a court filing that Janssen engaged in deceptive practices from 1998 to at least 2004 in the marketing of the drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. The multistate settlement comes amid a similar federal case that is still pending."

Schneiderman said the company promoted "off-label" uses of the drugs not approved by the Food and Drug Administration. For instance, Janssen is accused of promoting Risperdal, which is used to treat schizophrenia and other mental illnesses, for non-approved uses including dementia, anger management and anxiety. Janssen rewarded doctors who prescribed and promoted Risperdal for unapproved uses with lucrative consulting agreements, according to Schneiderman's complaint. 

(emphasis mine) here

I would only add, not only did the drug complany have no evidence the drugs were effective for any "off label" uses; J&J had no evidence the drugs were SAFE for children or the elderly...
I'd be a whole lot happier to read that primary victims will be helped to recover from their iatrogenic injuries...some of the victims were children...one of them, is my son...

Does anyone besides me wonder, how many children are on Risperdal in Washington State right now? How many children are still being prescribed Risperdal (or any other neuroleptic drug) "off label"?

It is Criminal: Doctors Do Not Disclose Risks of Psychiatric Drugs

Isaac before Risperdal

Psychiatric Mythology: Evidence-Based Diagnosis and Treatment

The fraud and corruption of Johnson and Johnson, and all the other pharmaceutical industry thugs could not have been done without the willing participation of psychiatric researchers who conducted biased trials that were part of a drug marketing agenda, then published biased reports in 'peer- reviewed' professional journals.  The research was structured and conducted to serve the marketing agenda and profit goal of the Pharmaceutical industry. This formula became psychiatry's gold standard, since the marketing goals were spectacularly achieved using these unethical methods. Apparently, the ends justified the means.

I am disgusted by the errors of attribution, flawed methodology, half-truths and outright lies; essentially what amounts to 'psychiatric mythology' which was developed to 'standardize' psychiatric diagnoses and psycho-pharmacological treatment.  All of this was done to institute a bio-disease paradigm in the diagnosis and treatment of emotional and behavioral issues within the publicly-funded mental health treatment system.  No genetic defect or dysfunction, no neuro-biological pathology of known or unknown etiology had been identified; yet this lack of empirical evidence does not stop these 'doctors' of psychiatry from authoritatively stating psychiatry is in fact treating 'brain diseases' that are incurable.  Why would this be done?

Apparently, it is done to coerce and manipulate patients and their family members to gain their cooperation and maintain 'treatment compliance.'  Stating false claims in order to alter through the use of deception a person's behavior, is fraud.  It is a crime. It is not an ethical method to medically diagnosis and prescribe medical treatment to a suffering patient.

Misinformation that psychiatrists have falsely claimed is medical knowledge, specifically, the disease metaphor; i.e. Psychiatric Mythology, became the foundation of Public Policy for the diagnosis and treatment of emotional and behavioral difficulties and extreme states experienced by people given psychiatric labels.  Legislation depriving people with psychiatric diagnoses of basic Human Rights and individual protections people without a psychiatric label take for granted have been passed in 46 states.  Rules of Evidence are not required, so gossip, innuendo and even perjury are allowed.

Involuntary Treatment Laws "deal with the mentally ill" who are purported by bio-psychiatry to lack insight; and cannot know whether psychiatric treatment hurts or helps them--and supposedly this is the primary reason they must be forced by Court Order.  Bio-psychiatry practitioners and advocates who are proponents of drugging emotional distress and behavioral difficulties as diseases, are seemingly not troubled by the fact that a significant percentage of individuals diagnosed and targeted by their teratogenic treatment, do not experience an appreciable reduction in symptoms from taking these dangerous psychiatric drugs; but do experience the iatrogenic diseases and disabilities.  The traumatizing, disabling effects of the drugs and the dishonest, coercive and manipulative methods used to gain 'treatment compliance' are why treatment is unwanted and avoided by some; OBVIOUSLY.  It is unwanted and avoided according to these all-knowing (apparently psychic) 'medical advocates,' and psychiatrists, because their unwilling patients/victims just  'don't know what's good for them!'

Proponents of forced treatment do not even acknowledge the people who have experienced lasting harm from the negative impact of neuroleptic and other psychiatric drugs; or the coercive and manipulative methods used to trick patients.  The fact that some, like my son, have been "treated" without consent, into states of cognitive and physical disability; is criminal.  This damage is compounded by the failure of mainstream advocacy groups, Federally-funded Protection and Advocacy Attorneys, and Assigned Counsel, appointed to represent people facing involuntary psychiatric treatment under Court Order. Rarely, are victims of psychiatric abuse even acknowledged by public servants who have a duty to protect, serve and defend them.

Pretending that these survivors, and those who were killed by inefficacious and unethical "treatment" do not exist, is morally reprehensible.  My son is real, and so are all people with a psychiatric diagnosis; whether they are complying with psychiatric treatment or not.  All of us have Human Rights.  A psychiatrist claiming an ability to discern accurately when and if a diagnosed person lacks insight, is ludicrous.  There is no statistically relevant empirical data, evidence of 'disease' so this merely a ploy used to justify abuse of authority.  Standard Practice and Treatment Protocols and algorithms are based on subjective opinions, e.g. biases, errors of attribution and prejudices included.  Psychiatry continues to use treatments and treatment protocols developed using fraudulently collected and/or reported data.  This being the case, the assertion that treatment refusal is due to a person's 'lack of insight' is truly ironic; ethically questionable, all things considered.

Neuroleptics are called antipsychotics, but for a significant percentage of people who experience symptoms of psychosis, the drugs are in fact not 'anti' psychotic.  Neuroleptics are in fact terotagenic drugs which can cause multiple biological systems to become dysfunctional, and lead to disability.  The risk of taking neuroleptics includes sudden death--even children have died from taking them as prescribed.  Long term use can cause brain damage and decrease life expectancy by 25 to 30 years.   Proponents of forced treatment also do not talk about the rampant fraud in academia, which has propelled the prescribing of the newest and most expensive drugs to Medicaid and Medicare beneficiaries, often "off-label" in spite of the lack evidence justifying making indiscrimiate use of teratogenic drugs off-label a "Standard Practice."  This is not ethical  medicine; and when 'off-label" prescribing is coupled with not being given complete and accurate and information, it is a massive betrayal of trust and negligent.

My son is now twenty-four and the vast majority of the drugs he was prescribed as a minor, were prescribed "off label" and not approved for pediatric use at all---I was not ever told this; nor was I ever told of the risks which are inherent with neuroleptic use:  Risks which include dependency, diabetes, obesity, heart damage, neurological impairment, cognitive impairment, akasthisia, and tardive dyskinisia.  The deleterious effects of the drugs on my son's health were attributed to his diagnosis; even though the adverse effects are documented in the professional literature.  I am so angry about the enormous betrayal of being lied to by psychiatrists, who are 'medical professionals.'   The negative effects of neuroleptic and other psychotropic drugs were the symptoms used by psychiatrists to diagnose co-morbid metal illnesses and behavioral disorders.

There is no doubt that there are those who need help accessing effective treatment and support services.  Proponents of "Court Ordered Treatment" whether inpatient or in the community focus on psychiatric drugs, to the exclusion of other Evidence-Based treatments and rehabilitative services.  Psychiatric drugs are not "safe" in any real sense of the word, and are not medicinal treatment in the Hippocratic tradition. They are more like the drugs used in oncology yet are marketed widely to particularly vulnerable people as safe and effective.  All psychiatric drugs have very serious risks; risks which are rarely discussed openly and honestly.  To this day neither I, nor my now grown son has ever had even one respectful or honest dialogue with a psychiatrist who has ever prescribed neuroleptic or other psycho-active drugs to him.

The facts are ugly:

1. The risks, once known, were hidden on purpose--lied about and covered up by psychiatric researchers, and their pharmaceutical industry co-conspirators and financial benefactors.

2.  The harm done to countless thousands (millions actually) has in fact been minimized as the "necessary risks" of "effective treatment," or worse, dismissed as, "tolerable side effects" by psychiatrists and others who prescribed the drugs.  This is why it is claimed the patients lack insight, and their complaints are ignored !

3.  The drugs are dangerous; neuroleptics and other psychiatric drugs are known to cause cognitive and intellectual decline---and we Court Order people to take them based on psychiatric fraud and deception. Brain damage occurs with long-term use;  I've seen it happen, suddenly and profoundly as well...

Given these facts, how is is justifiable that children are being given these drugs, to treat symptoms for which there is no valid medical justification to prescribe them?  Why are parents and guardians, or adult patients not being given the information necessary to determine whether the potential benefits outweigh the possible risks?  Given the serious risks, how can we as a society, justify forcing people to take drugs which can cause them to develop serious debilitating  metabolic and neurological illnesses, that can be disabling, and lead to early and/or sudden death?  This does not "help" those who are vulnerable, in crisis, and in need of kind, compassionate care.  It is not "helpful" to force people to take drugs which cause parasympathetic nervous system dysfunction, cognitive decline, and limits their abilities; putting them at further risk of sudden or early death.  Just because a drug is prescribed, does not mean the drug is "medicinal," "therapeutic," or even ethical treatment that is being provided to the patient.  Without Informed Consent, it is in fact criminal.

I am only a mother whose child was prescribed neuroleptic drugs "off-label" in a surreal horror story:  It is as if some very twisted combination of a marketing scheme and a pseudo-medical horror movie about Psychiatry. The goal is convince people that symptoms of emotional distress and behavioral difficulties, regardless of their etiology, are symptoms of a life-long biological diseases or genetic dysfunction.  The "treatment," is always drugs and/or electroshock which can and does cause disease and dysfunction.

Patients are purposely misinformed when they are told they have a disease or imbalance; then when drug-induced dysfunction is recognized it is attributed to the progression of the "disease."  Psychiatrists have told family members that their loved one with a psychiatric diagnosis has a "brain disease;" and just don't know they should take their medicine; they have 'no insight.' Telling parents and other family members that, 'the 'side effects' are unpleasant, but your loved one must take the drugs is a social control tactic.  Implicit is the idea/judgement/"support" to help you believe  you need to use manipulation and coercion; you need to lie to them,  'for their own good.'  Is it really surprising the lack of trust many people have for "mental health treatment providers" and for psychiatry? Why would anyone trust an individual who lies; let alone a group of professionals whose knowledge base is riddled with falsehoods and believe lying to and about patients is ethical and is necessary to implement a 'medical treatment' strategy?  These are in reality, bullying tactics.

Outcomes for the patients are obviously not as important as never questioning the medical model of "mental health treatment," and being compliant---Consent, or a psychiatrist or other mental health professional ethically sharing information about the risks and potential benefits of psychiatric drugs with adult patients or parents of diagnosed children, is not necessary---people with a psychiatric diagnosis, and family advocates are to be told no more than necessary to gain compliance with the chosen Practice Parameter and Treatment Protocol.  Charles Huffine, M.D. told me, "Parents who objected to medical treatment they (psychiatrists) would see as at best ill informed and at worst impaired themselves."

There it is Ladies and Gentlemen: The unvarnished, unadulterated truth of bio-psychiatry:  Parents who do not agree to drug their children must be ill-informed, or impaired themselves!  Ironic really, when you consider parents may be ill-informed by the psychiatrists who are making this judgment! Implicit in this statement is the belief that parents have no right to refuse consent to psychiatric treatment on behalf of their children, or make any decision for their child which a psychiatrist or other mental health professional disagrees with.   In effect, the risk vs. benefit analysis and consent is solely the provenance of the psychiatrist, or other mental health professional?!

When a prescriber fails to fully inform adult patients and/or parents of child and adolescent patients, and fails to engage the diagnosed person and support persons in an honest, respectful dialog which culminates in a shared decision---there is no consent, let alone, Informed Consent!  In this way, parents are effectively denied their Constitutional Rights as parents to make medical decisions about mental health treatment for their children without Due Process of Law; and often don't even know this has occurred. In fact it continues to be a threat---even though I have the legal authority to act on my son's behalf, when he is unable.  Parental Rights and Family Rights mean nothing to some psychiatrists or "mental health professionals" in my experience.

Judi Chamberlin Debates E. Fuller Torrey



First published June 11, 2011 edited and links added

TMAP Tragedy and Medicaid Fraud not all that important it seems

If we don't change the direction we're going, we're likely to end up where we're headed.

chinese proverb

The State of Texas recently settled a lawsuit with J&J that was ripe, good to go, all the ducks were in a row--know what I mean?  The suit was for $1 Billion then suddenly, it was settled for $158 million, a small fraction of that amount.   The corporate thugs are continuing to disable the populace on the taxpayers dime--with impunity; because in all reality, this amount is a drop in the bucket.


What I really want to know is why are WE the People allowing these modern day Robber Barons to rob ALL of us?!  This is no wild west spaghetti western sci fi!  These thugs are robbing ALL of us!  Texas was just the  proving ground for TMAP, the large-scale fraudulent psychiatric drug marketing agenda that spread to other states.  It was Texas that allowed these modern-day Robber Barons to incubate their illegal marketing agenda in the second most populous State in the Nation.  MY issue is how this New World Order marketing agenda was exported post-haste to Washington State, where I live and how it was crammed down my little boy's neck...


And then, I read this: via Health Care Renewal January 25, 2012:

Unequal Justice Under Law - Comparing Cases of Alleged Misbehavior by Large Health Care Organizations and Individuals

an excerpt:

On January 3, 2012, Bloomberg reported:

Two units of Actavis Group Hf will pay $84 million to settle a lawsuit over drug pricing, Texas officials said, less than half the amount an Austin jury said the company should pay.

The state accused Actavis Mid-Atlantic LLC and Actavis Elizabeth LLC, subsidiaries of the Iceland-based company’s U.S. division, ofinflating billings to the Texas Medicaid program by falsely reporting drug prices. The state court jury in February ordered the units to pay the state $170 million.

The settlement resolves that litigation, Texas Attorney General Greg Abbott said today in a statement.

Note that Medicaid is a joint federal-state insurance program for the poor. The company's statement had a familiar ring to it:

'Actavis denies any and all wrongdoing, and denies that it has any liability relating to the Texas judgment,' the company and the state said in the settlement agreement. The parties reached a settlement 'to avoid the delay, uncertainty, inconvenience and expense of continuing the litigation.'

Nothing to see here, just move along.  read here at Health Care Renewal

This settlement is more than the Attorney General of Texas settled with J&J for in the Risperdal illegal marketing case, which is less than 20% of what Texas should have collected.  Why would settlement with these thugs even be an option?  I am beginning to wonder if these lawsuits are just for show, e.g.  not actually meant to curtail the ongoing fraud and corruption---which is continuing unabated.  Are they being undertaken only to give the appearance of taking federal crimes committed by pharmaceutical companies seriously?  When it gets right down to it, the people who are being disabled and killed are not getting anything but screwed either way...