Off Label: Neuroleptic prescriptions are fraudulently billed to Medicaid

,

via Bonkers

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

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

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

click to enlarge

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

6-11 year old children on Medicaid pdf download

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

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

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

12-18 year olds on Medicaid pdf download

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

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

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

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

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

Best of the 2012 Academy Health Research Meeting

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

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

Article first published online: 4 SEP 2012

DOI: 10.1111/j.1475-6773.2012.01461.x

© Health Research and Educational Trust


Issue


Health Services Research


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

Funded by
Agency for Healthcare Research and Quality

Keywords:

Antipsychotics;
mental health;
pediatrics;
Medicaid

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

via AACAP:
 Prescribing Psychoactive Medication for Children and Adolescents

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

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

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

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

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

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

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

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

via The Alliance for Human Research Protection:

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

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

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

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

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

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


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

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

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

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


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

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

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

Contempt is like respect, it must be earned. 

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

TEOSS Drug Trials 

Double Blind... 

 an excerpt:

Acknowledgments

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

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

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

The Adverse Effects of Psychiatric Drugs

Vintage drug ad from Bonker's Institute for Nearly Genuine Research

Advancing in the direction of bona fide medical science since last Tuesday.

via Peter Breggin on youtube

Uploaded on Mar 23, 2011

Attorney Sheller's talk: The Intersection of Law and Overprescribing by Physicians, Nurse Practitioners, Etc. Focusing on Anti-Psychotics and Anti-Depressants.

Visit: http://sheller.com/

Dr. Breggin's talk: The Harms of Psychiatric Drugs, & Alternatives for Children.

Visit: http://breggin.com

Peter R. Breggin's Facebook page here

The Top Ten Adverse Reactions for the two neuroleptic drugs prescribed to my son the longest:
via Medwatch

 Risperdal/Risperidone

Diabetes Mellitus (1016 cases) Weight Increased (989 cases) Death (668 cases) Somnolence (572 cases) Suicide Attempt (566 cases) Drug Interaction (533 cases) Type 2 Diabetes Mellitus (486 cases) Drug Ineffective (454 cases) Extrapyramidal Disorder (438 cases) Neuroleptic Malignant Syndrome (435 cases)

Clozaril/Clozapine
Death (2403 cases)
White Blood Cell Count Decreased (1299 cases)
Granulocytopenia (1246 cases)
White Blood Cell Count Increased (1200 cases)
Malaise (1127 cases) 

Pyrexia (1097 cases)
Neutrophil Count Decreased (1036 cases)
Pneumonia (977 cases)
Tachycardia (942 cases)
Haemoglobin Decreased (884 cases)

Therapeutic Means to Stop Over Prescription of Antipsychotic Medication to Children

via PsychRights channel on youtube:

from psychrights:
Presentation by adult and child psychiatrist, Tony Stanton, describing the extremely successful Seneca program in Northern California, which had a 100% success rate in getting the most difficult and over-medicated children and youth off psychiatric drugs and successfully engaging in life.

"There's enormous anguish" caused by a lack of ethical integrity....

via the New York Times:

Drugs Used for Psychotics Go to Youths in Foster Care 

By BENEDICT CAREY Published: November 20, 2011 

a couple of excerpts:

"Foster children are being prescribed cocktails of powerful antipsychosis drugs just as frequently as some of the most mentally disabled youngsters on Medicaid, a new study suggests. 

The report, published Monday in the journal Pediatrics, is the first to investigate how often youngsters in foster care are given two antipsychotic drugs at once, the authors said. The drugs include Risperdal, Seroquel and Zyprexa — among other so-called major tranquilizers — which were developed for schizophrenia but are now used as all-purpose drugs for almost any psychiatric symptoms." 

“The psychiatrists who are treating these kids on the front lines are not doing it for money; there are very low reimbursement rates from Medicaid,” said Dr. Ramesh Raghavan, a mental health services researcher at Washington University in St. Louis. “There’s enormous anguish because everyone knows that this is not what we should be doing for these kids. We as a society simply haven’t made the investment in psychosocial treatments, and so we are forced to rely on psychotropic drugs to carry the burden.” read here.

The final paragraph frankly, made me extremely angry---it is a disgusting attempt to justify something that is not in fact NOT justifiable--no matter how much these poor unfortunate psychiatrists who "treat" children feel they are underpaid by Medicaid!   

Anybody who is above ground, and not in a coma, who has the ability to think critically, knows the reason, "We as a society simply haven’t made the investment in psychosocial treatments."  It is because psychiatrists misled and outright lied about what was known, and not known about the nature of the conditions they diagnose and treat, and lied about the treatments as well! Stating psychiatric symptoms are evidence of diseases of the brain, and/or "chemical imbalances;" to market the bio-psychiatry belief system, is fraud not ethical medicine. Illusory "neurobiological" diseases which are treated with disabling and teratogenic treatments that are ineffective and even tortuous to a significant percentage of patients.  

Psychiatrists lied about the safety of the drugs they use, and over exaggerated the drugs' potential for actual benefit; published the lies in professional journals and textbooks; taught the lies to students in Institutions of Higher Learning, and continuing education programs.  So, when this researcher stated, “There’s enormous anguish because everyone knows that this is not what we should be doing for these kids." I almost vomited.  

I am certain the anguish the professionals experience is nothing like psychiatric patients who are harmed by psychiatric treatment; and the parents who have buried their children, who are victims of iatrogenic, "physician caused" homicide.  I know that I am damn lucky my son is alive, knows who he is, and where he lives, literally. The drugs have done to his overall health  exactly what the drugs have always done. The first neuroleptics were used before I was born; the "new" ones, like the old ones, cause permanent neurological, cognitive, and physical impairments, disability and increased mortality.

I know that I have never had any psychiatrist tell me the facts I have found out myself about these drugs ever.  I have had the last two psychiatrists who "treat" my son look me right in the eye and tell me the drugs do not cause brain damage. One said it 3 times, and then demanded my respect.  That day, I had posted the American Psychiatric Association's newsletter discussing the brain damage the drugs are in fact known to cause!  This was less than a year ago. There is no solace in knowing the doctors who treated my traumatized child were misinformed, or simply indoctrinated into a belief system that medicalizes all emotional and behavioral problems.  There is no changing the past.  

I simply hope to one day take my son to a doctor who has the ethical integrity 
to tell the truth.

oringinally  titled, "There’s enormous anguish because everyone knows" 

If your child is 13 in Washington State he or she can be prescribed drugs without your knowledge or permission

Washington State has some very strange ideas on what a minor can and cannot consent to. How many parents are aware of the risk these Laws and current standard practices pose to their children?

Washington State Law on Providing Health Care to Minors
Your child can get an abortion, be prescribed psychiatric drugs that can potentially disable them; that have fatal risks. Your consent is not required; you won't even be notified so you can watch for adverse effects...

via Alliance for Human Research Protection (links disabled)

Antipsychotics pose "Ominous long-term health implications" for children_JAMA

Wednesday, 28 October 2009

Prominent psychotropic drug investigators acknowledge that the rapid onset of cardiometabolic risks" is "alarming." They recommend that consideration be given for lower-risk alternatives. A study published in the current issue of The Journal of the American Medical Association [1], confirms that children and adolescents who are prescribed second generation neuroleptics are put at high risk of severe harm: prominent psychotropic drug investigators acknowledge that the rapid onset of "cardiometabolic risks" is "alarming." They recommend that consideration be given for lower-risk alternatives. This government-sponsored study is the largest ever conducted on first-time users of neuroleptics (a.k.a. antipsychotics). It sought to document the association of second-generation neuroleptics (antipsychotics) with body composition and metabolic parameters in patients not previously exposed to antipsychotic drugs. The four drugs in the study—Zyprexa (olanzapine), Risperdal (risperidone) Seroquel (quetiapine) and Abilify (aripiprazole)—are the most popular antipsychotic medications. They are industry blockbusters, with combined sales of $12.7 billion last year. Two hundred and fifty seven young children and adolescents, aged 4 to 19, in the New York study added 8% to 15% to their weight after taking one of four neuroleptics for only 11 weeks. Will the indisputable evidence of “ominous long-term health implications” from use of antipsychotics prompt the FDA to ban their use in children??? read the entire article at ahrp.org here.

Evelyn Pringle in OpEd news in 2006:
"A recent USA Today sponsored review of the FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with atypical antipsychotics listed as the "primary suspect," and 1,328 reports of other serious side effects, some life-threatening.

The FDA's adverse event reporting system is known to capture only between 1% to 10% of side effects and deaths, which means the true numbers are actually much higher.

Among the 45 deaths, discussed in the May 2, 2006, USA article, at least six were related to diabetes, and other causes ranged from heart and pulmonary problems to choking, liver failure and suicide.

An 8-year-old boy died of cardiac arrest. A 15-year-old boy died of an overdose and a 13-year-old girl experienced diabetic ketoacidosis, a deficiency of insulin. The youngest child was 4, with symptoms that indicated diabetes complications." read here.

AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY 
PRACTICE PARAMETER FOR THE ASSESSMENT AND TREATMENT OF 
CHILDREN AND ADOLESCENTS WITH SCHIZOPHRENIA
This parameter was developed by Jon McClellan, M.D., and John Werry, M.D. and the Work 
Group on Quality Issues: William Bernet, M.D., Chair, Valerie Arnold, M.D., Joseph 
Beitchman, M.D., R. Scott Benson, M.D., Oscar Bukstein, M.D., Joan Kinlan, M.D., Jon 
McClellan, M.D., David Rue, M.D., and Jon A. Shaw, M.D. AACAP Staff: Kristin Kroeger.  
"Tardive Dyskinesia:  Tardive dyskinesia  (TD) is an involuntary movement disorder 
usually consisting of athetoid or choreic movements in the oro-facial region, but may 
affect any part of the body (Ernst et al., 1998). TD is a major public health concern in 
the treatment of schizophrenia, with both clinical and medicolegal implications. TD is 
typically associated with the long-term  use of neuroleptics (Ernst et al., 1998).  
Withdrawal dyskinesia may occur with  either gradual or sudden cessation of 
neuroleptic agents.  As many as 50 percent of youth on neuroleptics may experience 
some form of tardive or withdrawal dyskinesia (Ernst et al., 1998, Kumra et al., 
1998).  Withdrawal dyskinesias almost always resolve over time, whereas tardive 
dyskinesia may persist even if the antipsychotic agent is discontinued. 
Because there is no specific treatment for tardive dyskinesia other than 
discontinuing the medication, strategies for prevention and early detection need to be 
followed (APA, 1997)."  Practice Parameters

via Psychiatric Times May 6, 2011:
CLINICAL & RESEARCH NEWS Brain Volume Shrinkage Parallels Rise in Antipsychotic Drug Dosage  Aaron Levin
A magnetic imaging study of people with schizophrenia indicates that their brain volume decreases with use of antipsychotic medication. But what does that mean?

Magnetic resonance imaging of the brains of patients with schizophrenia suggests that while treatment with an antipsychotic drug may alleviate symptoms, it may also contribute to reductions in brain volume.

“It is possible that, although antipsychotics relieve psychosis and its attendant suffering, these drugs may not arrest the pathophysiological processes underlying schizophrenia and may even aggravate progressive brain tissue volume reductions,” said Beng-Choon Ho, M.D., an associate professor of psychiatry at the University of Iowa Carver College of Medicine, and colleagues in the February Archives of General Psychiatry.

The reduction in brain volume in schizophrenia occurs not because brain cells die off but rather because dendrites shrink and dendritic spines shrink, causing shrinkage in the synaptic connections in the cortex, explained Jeffrey Lieberman, M.D., another schizophrenia researcher not affiliated with the Iowa study.(emphasis mine)

“That's why in people with schizophrenia, thinking becomes more stereotyped, routinized, and concrete,” said Lieberman, a professor and chair of the Department of Psychiatry at Columbia University College of Physicians and Surgeons and director of the New York State Psychiatric Institute.

“They don't have the elaborate richness of synaptic connections to allow for the cognitive and intellectual processes to occur,” he said in an interview with Psychiatric News. read here.

It is definitive: The drugs cause brain damage, among other physiological neurological damaging effects.  How many parents or children thirteen and over are told this fact?  I sure wasn't.  There has been ample evidence in the professional literature of the deleterious effects of these drugs for decades---however, the drug industry denied the iatrogenic illnesses and the deaths caused to clinical trial participants and in the general population in real world use of these drugs; and the FDA claims it has NO duty to inform the public, of these facts.  The deaths and disabilities caused to patients who take the drugs are "Trade Secrets" according to the FDA.

Bipolar Biedermania

Joseph Biederman

According to the psychiatrist who writes 1 Boring Old Man, as well as many others on the planet,(including me) Joseph Biederman basically invented juvenile Bipolar disorder.  It appears Biederman did this in order to expand the market for profitable psychiatric drugs used to treat the diagnosis.  Biederman is one of several research psychiatrists who have conducted themselves unethically, and who are responsible for the widespread use of dangerous psychiatric drugs in the pediatric population.  He is one of the worst, and has acted without regard for his patients, or the patients of the professionals who relied on his research; which as it turns out is seriously flawed.  Biedeman's research appears to be more along the lines of pre-marketing work for the drug companies who funded him.  This research psychiatrist helped Johnson&Johnson with it's massive "off-label" marketing fraud of Risperdal.  As  "Key Opinion Leader" he recommended using neuroleptic drugs in spite of there being no valid clinical trial data to support their use.  Risperdal, like all neuroleptic drugs, alters normally functioning neurological, metabolic and endocrine systems causing dysfunction, which can lead to obesity, diabetes, cognitive impairment, disability and death; to name a few of the risks...


via  1Boring Old Man

"Some of this might even make good comedy if it weren’t such a serious topic. This saga actually speaks for the decade and a half it spans. It resulted in the unnecessary medication of lots of kids with potent and potentially toxic medications; it furthered our profession’s reputation as riddled with crooks; it so muddies the water that we have no idea if the resulting library of literature on childhood affective disorder has any meaning at all; and it did little for the prestige of Harvard University. All it really did was jack up the cost of health care and inflate corporate sponsor’s annual reports. There’s nothing to be proud of here…"  (empasis mine)  Read it here.

Parents who have children being given any psychiatric diagnosis need to know that there is much more to question about the psychiatric labels and the drugs used to threat the symptoms associated with them, than there is to be comfortable with.  Professionals may tell you that a diagnostic label bestowed upon your child is due to an underlying 'Brain Disease', 'defect' or 'Chemical Imbalance'---when in fact, none has been identified to date---it is an unproven hypothesis----not substantiated even once; it is not not even a theory; and certainly not a medical fact or certainty!  The story of disease and imbalance is based on the drugs actions once ingested, not on any underlying pathology, genetic defect, or somatic dysfunction identified in your child---or in any child.   

 Demand accurate information, seek it out and know the risks!

A little more from 1 Boring Old Man:

"But the original study by Aman et al in 2002 never mentions the word "bipolar" – ever. Is there any other evidence that the Biederman study might be ghost-written? How about this? At the bottom of the first page of the Biederman et al article, it says, "Printed in the USA. Reproduction in whole or part is not permitted. Copyright © 2006 Excerpta Medica, Inc." Remember Excerptia Medica? It’s the medical information company around the corner from Janssen headquarters in NJ, the one implicated in ghost-writing any number of Janssen articles by theRothman Report [detestable…] [see my post gpp?…].

Several things. This study is about medicating disruptive, low IQ kids for behavior control with Antipsychotics. It was later revived as treating "bipolar" kids. And it looks like the shots were being called from Janssen corporate offices with Biederman and the Harvard group added on for prestige.

I repeat – detestable!…"

Not only is it detestable; it is criminal.  Witnessing what these drugs have done to my son's physical health, and the continued cognitive and intellectual decline, due to neuroleptic and other psychotropic drugs, is an ongoing nightmare.  There is no doubt in my mind that these drugs should NOT be used in the widespread indiscriminate manner they are being prescribed. 

Videos

The Watch List: The medication of foster children

January 7, 2011

Nearly one in every 10 American children is diagnosed with a mental health disorder. Often the treatment prescribed is medication, and often the medication is heavy-duty — so-called antipsychotic drugs.

In this report, you’ll see that foster care children are prescribed drugs at a rate much greater than that of other kids. Concern over their well-being — not to mention the amount it costs to treat them — has prompted the Government Accountability Office to investigate potentially abusive prescribing practices in America’s state foster care systems. The GAO findings are expected to come out later this year.

Need to Know correspondent Shoshana Guy went to Texas to investigate overuse of psychotropic drugs in foster children, as well as that state’s efforts at reform.

Watch Fri., Jan. 7, 2011 on PBS. See more from Need To Know.

                        

Series of 5 10 minute videos of Mother Telling What Happened To Her Son

FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which
has not always been specifically authorized by the copyright owner. Such
material is made available for educational purposes, to advance
understanding of human rights, democracy, scientific, moral, ethical, and
social justice issues, etc. It is believed that this constitutes a 'fair
use' of any such copyrighted material as provided for in Title 17 U.S.C.
section 107 of the US Copyright Law. This material is distributed without
profit.