The over-diagnosis of early onset schizophrenia and other irregularities in psychiatry

Judith L. Rapoport, M.D.
		Judith L. Rapoport M.D. is Chief of the Child Psychiatry Branch NIMH. She is a graduate of Harvard Medical School. She did her clinical and research training at the Massachusetts Mental Health Center (Boston), Children's Hospital (DC), and the Karolinska Hospital (Stockholm). Her research has focused on diagnosis in child psychiatry, Attention Deficit Hyperactivity Disorder and Obsessive Compulsive Disorder. Over the past decade, her group has been studying the clinical phenomenology, neurobiology and treatment of Childhood Onset Schizophrenia. She is an author or coauthor of over 300 scientific papers, a member of the Institute of Medicine, and a Fellow of the American Academy of Arts and Sciences.

A brief clip of a recent webinar:

Out of 361 kids initially screened as potential participants in a phenomenology, neurobiology and pharmacologic response study, 37% of them, a total of 132 kids were determined to have been incorrectly diagnosed with schizophrenia, and were excluded. 229 were presumed to have been accurately diagnosed with schizophrenia, and 228 of these were observed at an inpatient setting over a period of several weeks. Upon discharge, only 126 of the 228 were believed to have a diagnosis of schizophrenia, e.g. 34.9% of the original 361 kids who had been diagnosed and were screened for potential participation in this study by Rapoport and her colleagues had been (presumably) accurately diagnosed with schizophrenia....

Diagnostic disagreement is not simply a problem caused by a lack of inter-rater diagnostic agreement, it is more a problem caused by the lack of empirical data to support and validate the diagnostic criteria. The rate of diagnostic disagreement in this study effectively demonstrates how dangerous and unreliable the DSM is.



The current psychiatric treatment guidelines adopted by the APA and the AACAP are developed using a quasi-democratic process to achieve consensus. The first line treatment always recommended for a diagnosis of schizophrenia in professional guidelines, practice parameters, and treatment algorithms is neuroleptic drugs. 

Expert opinions are not a valid substitute for empirical evidence; nonetheless, expert opinions are relied on (presumably) because the available evidence does not support the treatment recommendations promulgated through a political process in which psychiatrist's expert opinions are used to pseudo-validate the recommendations and used to justify the prolific prescription of teratogenic drugs, as a "necessary medical treatment" regardless of the therapeutic value to psychiatric patients who are labeled and targeted for psychiatric treatment... 

Psychiatry is obviously NOT an ethical medical specialty! 

watch on youtube      the slides for Judith Rapoport's presentation

Here is what the NIMH website says about this project:

"Since 1990, the NIMH has been recruiting patients with onset of schizophrenia before age 13. Major goals are to study brain development during childhood and adolescence in early onset schizophrenia patients. Preliminary genetic studies show association with a number of schizophrenia risk genes such as GAD and NRG1, supporting continuity with the adult disorder. In addition, abnormal brain developmental trajectories in patients and their full healthy siblings are seen in relation to risk alleles for these genes. Treatment studies have shown the unique benefit of clozapine for treatment resistant patients. A new study of transient cortical electrical stimulation has begun for control of selected symptoms. (emphasis mine)

"Children and adolescents meeting DSM-IV criteria for schizophrenia are being recruited nationally for a study of the phenomenology, neurobiology and pharmacologic response of childhood onset schizophrenia. Over 300 medical records have been reviewed from which 320 patients and their families, appearing to meet DSM-IV criteria for schizophrenia with onset of psychosis prior to age 12, were screened in person. Of these 225 were hospitalized for medication free observation.  A total of 112 received the diagnosis of schizophrenia at NIMH screening. A large number of children are receiving the diagnosis of schizophrenia improperly resulting in inappropriate treatment, even at academic centers. " here

Remember, according to Judith Rapoport's webinar and the slides she used, of the 361 kids screened for potential participation in the study, only 126 (34.9%) were believed to have schizophrenia at discharge.

The lack of empirical validity means psychiatric diagnosis is unreliable; the fact that mental health professionals have police powers to detain people make psychiatric diagnosis and treatment a risky proposition. The risk of disability and premature fatality are inherent, unavoidable risks for people of all ages who take psychotropic drugs; children and adolescents are known to be have an even greater risk for experiencing adverse effects, including drug-induced fatality. These pertinent facts make Jeffrey Lieberman's claims utterly irresponsible; being without a factual basis, his claims are unethical.

via Hearing Voices Network:

Basic information about voices and visions

via Intervoice:

Children Hearing Voices: What you need to know and what you can do

Free booklets for parents and supporters

What you can do if your child tells you they are hearing voices

1. Try not to over react, although you will be understandably worried, work hard not to communicate your anxiety to your child.
2. Accept the reality of the voice experience for your child: Ask them about their voices, how long they have been hearing them, who or what they are, do they have names, what they say etc.
3. Let your child know that lots of children hear voices and mostly they go away after a while.
4. Even if the voices do not disappear your child can learn to live in harmony with his/her voices
5. It is important to breakdown your child’s sense of isolation and differentness from other children. Your child is special, unusual perhaps, but normal.
6. Find out if your child has any difficulties or problems that they are finding very hard to cope with and work on trying to fix these problems. Think back to when the voices first started, what was happening to your child when they first heard voices? When did the voices arise for the first time? Was there anything unusual or stressful that might have occurred?
7. If you think you need outside help, find a therapist who is prepared to accept your child’s experience and work with your child in a systematic way to understanding and cope with their voices better.
8. Be ready to listen to your child if they want to talk about their voices and use drawing, painting, acting and other creative ways to help them describe what is happening to them.
9. Get on with your lives and try not to let the voice experience become the centre of your child’s life or your own.
10. Most children who live well with their voices have supportive families living around them who accept the experience as part of who their child is. You can do this too!

Criticism of Thomas Insel's TED Talk: Toward a new understanding of mental illness

via TEDTalks:

Near the end he says, "Now to be clear, we're not quite ready to do this. We don't have all the facts. We don't actually even know what the tools will be, nor what to precisely look for in every case to be able to get there before the behavior emerges as different. But this tells us how we need to think about it, and where we need to go."

There is no evidence that ANY psychiatric diagnosis is caused by an underlying disease pathology, no "brain disease" has ever been identified in any person alive or dead; making Insel's suggestion at the very least, premature. It is more of a statement of Insel's personal belief in the biological hypothesis of "mental illness." His speech is more a promotion for the unethical, but lucrative relationship between the American Psychiatric Association and the pharmaceutical industry.

via Integral Options Cafe:

"This video represents what is so painfully wrong about the medical model of mental illness. TED should be ashamed of promoting such patently misleading and financially motivated crap." here

via Neuroautomaton:

The TED Model of Mental Illness: Thomas Insel
an excerpt:
"In other words, Insel’s “early identification and prevention” premise is completely unsupported by the reality. In fact, the “evidence” he uses to support this strategy for going forward (from a very special case of childhood-onset schizophrenia) may have no correlate in very common and disabling disorders like depression. Even if we could implement society-wide brain scans at an early age, there’s a very good chance that there won’t be anything useful to discover there for predicting the course of common mental disorders." here

Mindhacks Blog Deeper into genetic challenges to psychiatric diagnosis

For more on the "science" behind the disease model of schizophrenia see Mary Boyle 'Schizophrenia' and genetics: does critical thought stop here?

Psychiatry, Medical Treatment, and FDA Approved Fraud

1956 ADVERTISEMENT

From the above advertisement, it more than plain that neuroleptic drugs called,  "antipsychotics" were marketed and prescribed to control children's "unruly behavior" from the time they were first developed...

It is plain that every Federal authority with a legal duty to protect the American people from the adverse effects of prescription drugs, has failed to do so diligently. The illegal marketing continues, while the off-label prescriptions for dangerous teratogens, i.e., FDA-approved psychotropic drugs, are fraudulently billed to the Federal Medicaid program.  Fraud continues unabated while mental health professionals "monitor" the prescription rates of teratogenic drugs prescribed to children that can disable and even kill them. These young patients and their parents are often not informed or the risks.; many are never told what the drugs mechanism of action is, nor are they told of the potential for experiencing serious adverse drug effects that may disable, or eve kill them. Corporate criminals are aided and abetted by regulatory failure; unethical medical professionals who use "standard practice" as an affirmative defense i.e. off label prescriptions that are unsupported by definitive evidence of safety and effectiveness; and Key opinion Leaders whose professional opinions are used to aid and abet the criminal marketing of FDA approved drugs. They're making a killing...

FDA-approved drugs kill far more people 

than alcohol and illicit drugs combined...

via Public Citizen
(a nonprofit organization that does not participate in partisan political activities or endorse any candidates) 


In 2008, Sidney M. Wolfe, M.D. testified before a House subcommittee that, "The situation at the FDA has never been worse than now and this can be attributed to a confluence of 3 factors:

  1.Terrible leadership at the FDA, including the Commissioner and most of the Center                          

• Directors
• 
  
• 2. Increasing reliance on industry to fund FDA activities, with almost 2/3 of the drug approval     budget coming out of the $400 million+ Prescription Drug User Fee Act (PDUFA) drug  allocation for FY 2008

  3. Relative to the 1970’s and 1980’s, a perilously low level of Congressional oversight and 

   oversight hearings by the same Congresses that have, since 1992, increasingly turned 

   over FDA funding to the industry" read here

via PloS Medicine:

Questionable Advertising of Psychotropic Medications and Disease Mongering

Jeffrey R. Lacasse1*, Jonathan Leo2 1 Florida State University, Tallahassee, Florida, United States of America, 2 Lincoln Memorial University, Harrogate, Tennesseee, United States of America 

an excerpt:
"Wayne Goodman, Chair of the FDA Psychopharmacological Advisory Committee, admitted that the serotonergic theory of depression is a “useful metaphor”—and one that he never uses within his own psychiatric practice [6]." read here

via the FDA Warning Letters and Notice of Violation Letters to Pharmaceutical Companies:

Shire Pharmaceuticals Warning Letter 2011 for Vyvanse an excerpt: "the subject of this letter is dated March 2008" --a warning sent three years after the fact?!

Noven Pharmaceuticals, Inc warning letter for Pexeva® (paroxetine mesylate) Tablets here

Novartis Pharmaceuticals Corporation Focalin XR® here

Pfizer Inc. CHANTIX®  (varenicline) Tablets CADUET®  (amlodipine besylate/atorvastatin calcium) Tablets NORVASC®  (amlodipine besylate) Tablets here

Sunovion Pharmaceuticals, Inc. warning letter for Latuda, a neuroleptic, or 'antipsychotic' drug an excerpt: "The sales representative’s statements are false or misleading because they promote an unapproved use and minimize the risks associated with Latuda.  Thus, this promotional activity misbrands Latuda in violation of the Federal Food, Drug, and Cosmetic Act"(emphasis mine) here these are all of the warning letters sent for psychiatric drugs in 2011 listed on the FDA website here.

via Mad in America Should the Medical Literature Be Cleansed of All STAR*D Articles?

Posted on May 5, 2011 by Robert Whitaker   a brief excerpt:

"In short, the falsely-reported results are driving prescribing practices and instilling a medical delusion about the effectiveness of these drugs." read here

The Code of Federal Regulations states that prescription drug advertisements must contain, "a true statement of the effectiveness of the drug for the selected purpose(s) for which the drug is recommended or suggested in the advertisement. The information relating to effectiveness shall include specific indications for use of the drug for purposes claimed in the advertisement"

Well it doesn't take a rocket scientist to figure out that the drug companies do not adhere to Federal Law.  Even when the drug industry is caught breaking the Law, the penalty does not serve as a sufficient deterrent; pharma has not stopped using illegal methods to gain FDA approval, or market it's products.  The FDA is failing as a regulatory authority; providing little, to no protection for the American people from iatrogenic harm and fatalities caused by FDA-approved drugs. It appears the drug industry is directing FDA approval and regulatory activity.  

The SSRIs (as the story goes) supposedly, 'safely treats depression thought to be caused by a 'serotonin imbalance.'   It is a disproved hypothesis, that became a fraudulent claim; a myth that has been used for decades to market SSRI antidepressants, and used to convince patients to take their antidepressants.  No serotonin imbalance, or any other neurotransmitter has ever been identified or validated as an actual biological cause of depression, or any psychiatric diagnosis!  It appears this hypothesis took on mythological proportions, and came to be accepted as a "fact, " but it is an "urban legend," without any basis in reality. This hypothetical myth, is a fraudulent claim that was repeated incessantly in drug advertisements, in professional journal articles, and in doctor's offices in "informed consent" discussions with patients and parents.  It is, and always was, a drug marketing strategy---a very lucrative and successful marketing strategy that has defrauded billions of dollars mainly from publicly funded medical programs...The FDA never sent a single warning letter to any of the drug manufacturers or the medical professionals who were promoting the chemical imbalance / brain disease mythology to advertise and market drugs; and to coerce patients into treatment compliance. The FDA allowed drug manufacturers, salesmen, medical professionals and Key Opinion Leaders to perpetrate fraud in order to sell FDA approved drugs with serious risks; risks that the FDA helped unethical researchers and manufacturers bury.  Not informing doctors or informing the American people in order to protect them from harm, makes it an FDA-approved fraud.

via NIMH Directors Blog December 14, 2011

Treatment Development: The Past 50 Years 

a few excerpts:

"Over the past year, several companies, including Astra Zeneca, Glaxo-Smith-Kline, Sanofi Aventis, and recently Novartis, have announced either a reduction or a re-direction of their programs in psychiatric medication R&D. Some of these companies (such as Novartis) are shifting from clinical trials to focus more on the early phases of medication development where they feel they can identify better targets for treating mental disorders. Others are shifting from psychiatry to oncology and immunology, which are viewed by some as lower risk.

"There are multiple explanations for these changes. For instance, many of the blockbuster psychiatric medications are now available in inexpensive generic form. In addition, there are few validated new molecular targets (like the dopamine receptor) for mental disorders. Moreover, new compounds have been more likely to fail in psychiatry compared to other areas of medicine. Studying the brain and the mind has proven to be much more difficult than the liver and the heart. Most experts feel the science of mental disorders lags behind other areas of medicine. The absence of biomarkers, the lack of valid diagnostic categories, and our limited understanding of the biology of these illnesses make targeted medication development especially difficult for mental disorders." emphasis mine read here

The last sentence emphasized above is ample evidence that Thomas Insel does not understand basic scientific principles; yet, he is the Director of the National Institute of Mental Health. The absence of an identified biological dysfunction or disease pathology, i.e. a treatment target, is characterized as a "difficulty" by Thomas Insel; it is a barrier. In medical research, development of targeted treatments follow the identification of a biological dysfunction or disease that is then "targeted" for treatment. Is it possible that Thomas Insel is unaware that conforming to scientific principles is required in ethical research?  An unknown, unidentified biological dysfunction or disease is a 'hypothetical' cause for psychiatric diagnoses; it cannot ethically become a target for treatment, unless it is a validated cause of a mental disorder. Without identifying a biological dysfunction or biological disease, it's impossible to validate the disease hypothesis. To proceed without valid evidence of a disease pathology, is unethical, unscientific and belies the ethical principles of scientific research. Using a hypothesis as means of explaining a diagnosis is entirely unethical, and dishonest; yet it is standard clinical practice, and has been for decades. Pharmachological treatment for undesirable emotional and behavioral symptoms in the belief they are caused by biological dysfunction or disease, without ever identifying or validating a biological dysfunction or disease that is validated as a cause of any mental disorder, is not and cannot be a valid or ethical medical treatment. Psychiatry's "medical diagnoses" that are not supported and validated by ethically conducted research, are mythological "diseases." Psychiatry's treatment standards that are supported not by empirical evidence, but by errors of attribution, corrupt data, and subjective, i.e. biased opinions;  are not medical treatments that conforms to ethical medical principles, or even "medical treatment"...

It is Human Experimentation and it is Standard Clinical Practice. 

It is standard "medical treatment" that can be forced Under Color of Law. 
Does that sound like good medicine that is "therapeutic? 

Update February 2, 2011 at 7 pm
Six FDA scientists and doctors have filed a Federal Lawsuit alleging the FDA retaliated against them  for voicing safety concerns about medical machines the FDA approved. 

via The Washington Post Federal Eye Blog on February 1, 2011 Grassley Investigates FDA monitoring of whistleblowers By Lisa Rein and Ellen Nakashima

an couple excerpts:  

"The plaintiffs contend the monitoring was a blatant form of retaliation. Information gathered this way eventually contributed to the harassment or dismissal of all six workers, the suit alleges.

"Grassley warned Hamburg that it is illegal for a government agency to interfere with an employee’s right to air concerns to members of Congress. He said the FDA had “no evidence” that one of the device reviewers, Paul J. Hardy, disclosed confidential business information about the devices, yet fired him after he exchanged Gmail messages with congressional staff, including an investigator who worked for Grassley."

“It is troubling to me to see your Agency actively pursue the dismissal of an employee ... not because they violated procedure and leaked genuinely confidential classified information, but simply because you “cannot trust him,” Grassley wrote. He told Hamburg the FDA’s retaliation against Hardy “directly contradicts” testimony she gave during her 2009 confirmation hearings of her intent to protect whistleblowers by “creating a culture that enables all voices to be heard.” read here

Fox in the hen house source
Vintage Drug ad source 
Regulatory and Ethical Failure in Mental Health Treatment and Drug Advertising 2-2-12

What was once an illusion is now delusion

via ScienceDaily:

Science News

Unruly Kids May Have a Mental Disorder

a couple excerpts:

"ScienceDaily (Apr. 29, 2012)  When children behave badly, it's easy to blame their parents. Sometimes, however, such behavior may be due to a mental disorder. Mental illnesses are the No. 1 cause of medical disability in youths ages 15 and older in the United States and Canada, according to the World Health Organization.

"It's also important to understand that mental illnesses are a developmental brain disorder even though they can look like behavior problems," Dr. Insel explained." read here

Insel's statement is not grounded in scientific findings, ethical medical principles or common sense. 

Thomas Insel, has been the front man for an effort to maintain the charade that psychiatry is an ethical medical specialty that treats actual diseases. Apparently, the "Stay the Course" agenda of treating emotional and behavioral difficulties children and adults experience as if the difficulties are symptoms of an unidentified "brain disease" requires no actual evidence. Without definitive evidence supporting the disease hypothesis, it isn't even a theory, let alone a scientific finding or medical certainty. Insel's statement is merely an unsubstantiated belief; a belief that belies understanding of the existent "evidence-base" and ethical medical principles. Insel is entitled to his opinions, but it is irresponsible and ethically unacceptable for him to share his opinions when being interviewed in his official capacity as the Director of National Institutes of Mental Health. The fact that his belief is shared by others who are convinced that the discovery of evidence that will vindicate their belief is right around the translational science corner, Insel's statement compounds the potential for confusion about what is and is not known about etiology of psychiatric diagnoses. Insel's lack of judgement in voicing his personal opinion, in effect, seems to confer a patina of scientific validity to a belief.

Firmly held beliefs and shared opinions are no substitute for empirical evidence; shared beliefs and opinions  do not imbue the standards used in psychiatric clinical practice with validity, safety and effectiveness. Absent the scientific evidence that is (theoretically) required in order for a diagnostic criteria and treatment protocol to be considered a valid, ethical, medical standard; mental illnesses have been declared by psychiatric decree to be caused by disease and/or defect, and treatment standards are developed using the same quasi-democratic process of consensus; becoming standards simply because they have been decreed to be standards by psychiatrists.  Psychiatry "validated" diagnostic and treatment standards with a quasi-democratic process, i.e. a vote taken by psychiatrists. If one carefully reads these standards and protocols it is apparent that empirical evidence is often not cited in support of the conclusions; empirical support is required to comply with and conform to ethical scientific and medical principles. The primary basis of psychiatric diagnoses and treatment protocols designated as standards of care for use in clinical practice is consensus; i.e. evidence of agreement. Agreement is no substitute for empirical evidence; consensus does not support or verify diagnostic and treatment validity, reliability, safety or effectiveness. Consensus cannot quantify risks to patients.  

Psychiatrists have been perpetrating fraud. Shared beliefs and opinions have been substituted for empirical evidence. Conviction that one's beliefs are valid is not empirical evidence of the validity of a hypothesis, nor is it a justification for psychiatry abusing it's medical authority or violating the trust of patients and families in the misguided notion the foundation of psychiatry's standards of care could be supported and validated by beliefs and opinions. More importantly, how does a conviction that one's beliefs and opinions are valid cause an individual, let alone virtually an entire medical specialty to justify using deceit, fraud and coercion to manipulate patients, to misinform and manipulate parents and others to be complicit in manipulating, controlling and coercing patients into being "treatment compliant?" Psychiatry has been using fraud, a crime, to implement and enforce an unethical standard of care in order to "medically treat" unidentified metaphorical diseases. This is not an ethical, medical practice obviously; nor is it done with an altuistic intent to serve a patient's best interest. Fraud is never used to benefit those who are being deceived; this fraud has been used to implement and enforce what psychiatry claims is "necessary medical treatment" for children and vulnerable adults diagnosed with mental illness for decades. Some are compelled under Court Order if they are unwilling to submit to psychiatric authority, which belies the claim that necessary medical treatment is what psychiatry provides, When did deceit, fraud, and coercion; outright criminal behavior, become acceptable methods to use in the practice of medicine?

The fraudulent claim is used in standard clinical practice to coerce patients and parents of children who are patients into believing there is a disease which requires psychotropic drugs to treat it. It is a fraudulent claim meant to convince patients and parents of children, of the necessity for "treatment compliance." It is used in order to perpetrate fraud.  A claim that is not based on facts used in the hope that if believed, it will modify a person's behavior and gain their cooperation, is by definition, a fraudulent claim, This particular claim is used specifically to convince adult patients, children, youths and their parents to comply with psychiatric treatment. People who believe the claim and comply with psychiatric treatment have, more often than not, sustained iatrogenic injuries; some have been disabled or killed by the direct adverse effects of the drug/s they were prescribed. How many patients and their families have been misled, and were never warned about the well-known adverse effects, iatrogenic injuries and diseases that are well-documented intrinsic risks of the drugs they are prescribed? 

I know from pain-filled experience that when these risks become actual injuries, psychiatrists will often claim the drugs do not cause the brain damage and other iatrogenic injuries; many will declare that even obvious iatrogenic injuries are simply symptoms of the psychiatric diagnosis itself.  I can assure you, as the mother of a victim of psychiatric abuse and torture, my agony is, at times unbearable, I know my son was intentionally victimized by dishonest, unethical psychiatrists who lied repeatedly, psychiatrists who abused their authority and power and used the disease hypothesis as an excuse to justify medical malpractice. Treatment not supported by evidence of safety and effectiveness is human experimentation; and it is an accepted practice in the standard of care used in clinical psychiatric practice. Every psychiatrist who treated my son, particularly the lead researcher for childhood schizophrenia, Jon McClellan, intentionally perpetrated fraud in their (mis)treatment of my son. A belief that my son's symptoms were evidence of an underlying disease, is not actual evidence---this now familiar metaphor is simply an intrisic part of the fraud being perpetrated by psychiatrists,  My son is neurologically and cognitively impaired; he has been victimized repeatedly in effect, he was tortured by psychiatrists who acted with impunity. Every single one of the so called doctors who (mis)treated my son knew he was a victim of horrific abuse; and every single one of them knew he had severe PTSD and Left Temporal Lobe Epilepsy as a result.

This new program that Thomas Insel is marketing, is the same old progrom.  It is certainly no way to regain lost credibility; absent ethical integrity, the psychiatric profession will continue to lose credibility for failing to be accountable for the harm psychiatric diagnosis and treatment causes. Stating this particular claim with authority when psychiatry still does not have valid and reliable diagnostic criteria, is unethical; and it is entirely irresponsible without definitive evidence an actual disease even exists.  In effect, Insel is claiming that without duplicable, reliable i.e. valid, data; that psychiatric diagnoses are in fact the result of an unidentified, and incurable pathology that has not yet been found.  This is nothing more than an attempt to use his authority and pseudo-scientific sounding terminology to continue to market the same old illusion that psychiatry is treating actual medical diseases. In truth, the drugs psychiatry uses cause diseases that psychiatrists then medically neglect; increasing the risks for iatrogenic disabilities, and decades early sudden death, which is in truth, homicide.  Insel apparently believes that psychiatrists can practice ethical patient-centered medicine without valid diagnostic criteria, and without relying on empirical evidence as the evidence-based foundation for practice parameters, treatment protocols, and standards of practice. 

Psychiatry isn't "evidence-based medicine." Without evidence, i.e. valid research data that supports and validates reliable diagnostic criteria, the treatments provided, and the standards of care used; it is evident that psychiatry does not value using sound ethical medical judgement or obtaining informed consent from patients. To some psychiatrists, these are not ethical duties performed, but affectations that are barely paid lip-service.

Primum non nocere.

What was once an illusion is now delusion.

portions of this post first published as "The illusion of psychiatry and 'Translational Science'" 4-29-2012

The Elements of Informed Consent for Clinical Research

via NIMH:

Clinically Tested or NOT: Using Risperdal for children's behavioral issues is NOT yobluemama approved!

NOT yobluemama approved!

My youngest son has paid a horrific price for the malfeasance of psychiatry, the FDA and the drug industry.  I would think no consumer's health should be risked because the prescriber's information and judgement is compromised by flawed, incomplete, or otherwise questionable data. Prescription drugs are marketed directly to the American public in advertisements with exaggerated claims of efficacy and safety, that minimize actual risks---No consumer protection laws prohibiting false advertising apply...


Altogether, psychiatry has failed to be honest about what is and what is not known about any and all psychiatric diagnoses and treatments!  The practice of psychiatry is permeated with deception, a lack of medical ethics, and a history of  using 'Standard Practices' that are not supported by clinical research.  Psychiatry uses social control strategies which are coercive and abusive.  The physical and emotional harm patients complain of is attributed to the patient's "lack of insight," or failure to be "treatment compliant."  Even worse, some practitioners deny the harm patient's experience altogether; or insist the harm is just the "tolerable" side effects of the "safe and effective" treatment they provide.  Using the Courts to force patients to take drugs or have "electro-convulsive therapy" because these are  the "only treatments" psychiatry has; it is the only treatments that the bio-psychiatry devotees use, but it is not the only treatments available.  It is morally reprehensible to state this as a justification for forcing people to have this "treatment."  Psychiatry has garnered the Force of Law using corrupt rearch, unethical medical practices and subterfuge.  A person targeted in this way has no rights at all once Court Ordered; my son was stripped of his Individual Rights to procedural due process just by having a Court Order sought.


via Jim Edwards on BNET on August 3, 2011:
"The FDA told Johnson & Johnson (JNJ) in 1997 that its(sic) request to market the antipsychotic drug Risperdal for children was “without any justification.” In the following years, J&J’s army of pharmaceutical sales reps made 100,000 sales calls on child and adolescent psychiatrists, justifying this by “qualifying” the docs if they had as few as one adult patient exhibiting signs of schizophrenia,"  


read the entire article:
Claim: J&J Wrongly Marketed Antipsychotic Drug Risperdal to Kids  on BNET by Jim Edwards


I am certain they started this crap before 1997 since my son was prescribed Risperdal in 1995---for a reason that is not an approved use for this neuroleptic to this day...I refer to the drugs called "antipsychotics" as neuroleptics; it is a more accurate term for the drugs.  It is misleading and deceptive to call them "antipsychotic," since the drugs are not "antipsychotic" for the majority of patients who experience symptoms of psychosis. The neuroleptic drugs are now more commonly prescribed for other psychiatric diagnoses and for symptoms other than psychosis. 


Neuro meaning nerve, or neurological and leptic meaning to seize, take hold of.  The drugs work on the central nervous system, and were first described as being as effective as a frontal lobotomy; no need for surgery.  How did neuroleptics become "treatment" for children with behavior problems?!  

Civil Rights violations are committed as a matter of course in stand practice which is not surprising given psychiatry's lawless conduct historically, acceptance of this fact permeates Academia, both in Educational and Research programs.  It is morally reprehensible that psychiatry's 'Standard Practices' were developed using fraud, deception, the Un-Informed Consent from patients, and coercion.  Why are patients and family members misled, and out right lied to about the 'safety and efficacy' of drugs, and why are people being given drugs that do not benefit them to the degree that the benefits actually outweigh the very serious adverse effects?   Why is  virtually every person who legitimately claims substantial harm due to psychiatric 'treatment' disparaged, mocked or ridiculed---if not ignored altogether?  


Why is psychiatry not demanding that adverse events caused by psychiatric drugs, including death, be reported to the FDA so they have a clearer picture how safe and/or effective the drugs really are?  


We know how many Americans are prescribed psychiatric drugs---we need to know how many are being harmed.  It seems to me that collecting this data is necessary to determine the validity of the safety and efficacy claims.  It is the real world outcomes that we need data on.  In the real world the damage caused by psychopharmachology is growing exponentially with a myriad of chronic iatrogenic illnesses, neurological impairments and social, moral, financial devastation. The iatrogenic harm experienced by psychiatric patients and their families must not be ignored any longer.  IMHO, the fiscal and social damage is contributing to the increase in discriminatory attitudes towards those who are labeled by psychiatric diagnosis and their families. Americans are bombarded with direct to consumer advertising  grass roots advocates allow education and advocacy programs to function as venues for pharmaceutical marketing campaigns.  Psychopharmacologists in effect, act as if the people they label are no longer worthy of having their Human Rights protected or defended.  The labeled are denied Equal Protection Under the Law---by 'doctors.'  


Psychiatry, as a profession does not hold it's practitioners accountable.  Discredited Harvard research psychiatrist, Joseph Biederman, is on the Scientific Advisory Board of a Consumer Advocacy group, CABF---or whatever they call themselves now.... The man is a crook who now 'advises' a nonprofit "consumer advocacy" group about the very condition he invented, and treatments he falsified research about which he then lied about it when he was caught!?!   


The so-called 'doctor' who insisted he had no duty to obtain Informed Consent for drugging my minor son, because in Washington State the Age of Consent for mental health and substance abuse treatment is thirteen; is still the 'Medical Director' of the only state-run psychiatric facility for children. My son could not have a conversation longer than two minutes, so there is NO WAY in HELL he had the capacity to give Informed Consent; and every staff member at that facility knew it.  This shining example of ego-driven psychiatry acted as if he were God; and needed no Informed Consent; his own approval for his 'treatment' plan which traumatized and disabled my son are all that Quack Master Jack required.  Apparently his intellectual superiority, allow him to abuse his authority and ignore medical ethics altogether.  Jon McClellan appears to not have a moral compass, professional integrity or sound clinical judgement. 

I almost vomited when I read in his CV he has received Awards for 'helping kids' recover and that he gives speeches on Ethics to non-profit groups.  The man is a thug in a white coat who broke the law, broke my son's spirit and Isaac says, "He stole my intelligence mom!"  This 'doctor' lied to my face so many times it makes me sick.  A doctor who uses his medical license as a symbol of infallible superior judgement while lying to patients and parents; and ignoring the Ethics Guidelines of the Medical Profession and the Hippocratic Oath, is not qualified to teach Ethics!  These two 'doctors' are not ethically qualified to be members of the Medical profession; let alone qualified to conduct reasearch and teach students, or advise patients, parents, and advocates or inform public policy!   


If you heard about a mechanic who had fixed a friend's car so well it that the car no longer could run; would you take your car to that mechanic?  Would you ask for advice from that mechanic?  Jon McClellan advises the State of Washington to this day; he is a criminal more than he is a "doctor."  


Massive financial fraud, corruption and the Civil Rights violations of those who are court ordered and forced to take drugs and/or receive electroshock  'treatment' both of which can disable or kill them; is not just,  is not Humane, and it certainly is not therapeutic; it is criminal.  The US District Court in Alaska dismissed a Medicaid Fraud claim brought by The Law Project for Psychiatric Rights, because fraud is widespread and ongoing!  What was the judge smoking!?!  This should in fact be a priority for the Department of Justice, as it has fiscal, social and moral relevance for all Americans.  The fraud and corruption has decimated Medicaid and Medicare budgets while causing some to became disabled and who then are forced to rely on other federally-funded social service programs.


This deception is eerily reminiscent of psychiatric 'Standard Practices' of the first half of the 20th Century. It is more than reminiscent, it appears to be using the same tactics.  A small group of individuals have laws passed which in effect, declare that some people are of a lower class, this is  determined by a psychiatric diagnosis; and being of this class means they do not need Equal Protection or have the same Human Rights as those without a diagnosis. Those who are labeled by psychiatry can lose their Liberty, and do not have the an effective means to defend against this loss of liberty, the loss of Liberty can be permanent, and may in fact cause their death.  Once Court Ordered, they must receive 'treatment' regardless of the treatment 's safety or efficacy, or lack thereof.  In Washington State people who have been Court Ordered to psychiatric treatment are entered into a tracking system for life; so they can be more easily identified and to make it easier to Court Order them again.  Didn't any of the so-called "advocates" for the mantally ill who lobbied for the passage of these Unconstitutional Laws, ever read any History books or the Constitution of the United States of America?   

The effects of drugs are commonly not shared with those who are taking them willingly; there must be a reason....Could it be they are not as safe or as effective as is being claimed?  To justify continuing this misguided 'treatment' strategy, and (inconceivably) to legitimize this pseudo-medical profession; more lies were told to subvert the truth. The 'treatments' were proclaimed to be, 'safe and effective' and psychiatric diagnoses were declared by psychiatric decree, to be 'brain diseases,' 'brain disorders' and 'chemical imbalances' which require life-long psychiatric 'treatment.'  


I am more than a little disappointed the American Medical Association has not taken a stand on the loss of health, liberty and life caused by psychiatry and it's pseudo-medical treatments. Psychiatry virtually ignores the Ethical Guidelines for Informed Consent and the Hippocratic Oath to, "First do no harm..." 

"Whenever a doctor can not do good, he must be stopped."  Hippocrates.

a final note:

What is with our public servants, don't State and National elected officials take an oath to protect and defend the preeminent Law of the Land as WE the People's elected representatives?  There appears to be little evidence of representing the interests of the people when formulating public policy, or the legislation that effectively enacts those same public policies.  It appears that when formulating public policy, elected officials find ways to erode and subvert, rather than Protect and Defend the Law.   


Sworn Oaths do not have any significance once a person is in the grip of a new diagnosis being considered for the DSM 5 that afflicts psychiatrists, "advocates" of bio-psychiatry and those elected to Public Office it is called, "Special Interest Mania," is a disease that robs it's victims of ethical integrity, and allows them to abuse their authority. It's symptoms emerge when Conflicts of Interest are ignored and no longer recognized. Symptoms include a lack of remorse, a lack of empathy, and intense feelings of fulfillment and euphoria when close to a funding source, or special interest lobbyist. A unique feature of this condition is how it affects everyone who does not have it: It causes those who are not afflicted with it to be screwed over, and may lead to being stripped of their Human Rights and may include being labeled with a psychiatric diagnosis in need of life-long psychiatric treatment with or without consent.


graphic credit

A Seeding Trial: Side Effects of Newer Antipsychotics in Older Adults updated

Trust me I'm a Ducktor

Updated on 12-5-2012

This is a comment that I left on the Mad in America website:

Being unethical doesn’t mean it does not happen. It does. In my opinion, off label prescriptions of psychotropic drugs, particularly prescriptions which are not based on clinical trial evidence, or even minimally supported by data about the drugs’ safety and effectiveness, (which is more common than not, in psychiatry) is Human Experimentation. Calling it “Off Label” instead of calling it what it is, is deceptive; and I believe it is done to deceive. This off label prescribing is theoretically supposed to be based on actual evidence of safety and efficacy, even if it is not from drug trials; the drugs have been in use for a very long time and STILL there is not the evidence available that what is being done in Standard Clinical practice is supported by EVIDENCE. So how the hell did this become a STANDARD PRACTICE? By a using a quasi-democratic process of collaboration and consensus of a few followed by the vote of a few more.  A group of people in effect have determined that voting on their own educated opinions and reaching a consensus is how to develop an "Evidence Base" for psychopharmacology.  Consensus is evidence of agreetment, it is not a substitute for the empirical data required to ethically justify implementing any medical care standard.  It is a dishonest and not at all ethical to use a collection of subjective opinions and observations AS IF they become scientific evidence by virtue of the number or "importance" of the individuals offering them.  Subjective observation is used to SUPPORT objective information NOT replace it... What are the Standards of Care in psychiatry, ie. practice parameters, treatment algorithms, etc. if they are not science-based ethical medical standards?  What the Standards of Care in psychiatry are is an affirmative defense for allegations of medical malpractice. In effect, and in fact, Human Experimentation without the knowledge or the consent of the human participants is standard practice it's "psycho" pharmacology!  

beginning of original blog post

Recently the disappointing outcome of a study using 4 neuroleptic drugs, called "atypical antipsychotics," was reported by UC San Diego and published in the online Journal of Clinical Psychiatry.  When I first read about this study at 1 Boring Old Man's blog, something seemed seriously wrong; but I couldn't put my finger on it right away. After doing a little digging, I realized what was bothering me. It appears the study was a seeding trial, conducted in an (unsucessful) attempt to "legitimize" gain FDA approval for what is being done in standard practice, the off-label prescription use of the drugs known to be ineffective for treating PTSD, Alzheimer's Disease, and Dementia.  All four drugs have an FDA Block Box Warning for increased mortality when used to treat dementia; i.e. dementia is not an FDA approved indication for the drugs used in this trial. Another condition mentioned by the UC San Diego press release is PTSD; PTSD is not an FDA approved indication for the drugs either. In fact, PTSD is not even mentioned among the three conditions listed for intervention with this drug study at ClinicalTrials.gov.

via UC San Diego Health System:

Four Common Antipsychotic Drugs Found to Lack Safety and Effectiveness in Older Adults

some excerpts:

"In older adults, antipsychotic drugs are commonly prescribed off-label for a number of disorders outside of their Food and Drug Administration (FDA)-approved indications – schizophrenia and bipolar disorder. The largest number of antipsychotic prescriptions in older adults is for behavioral disturbances associated with dementia, some of which carry FDA warnings on prescription information for these drugs." (emhasis mine) 

The study looked at four atypical antipsychotics (AAPs) – aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal) – in 332 patients over the age of 40 diagnosed with psychosis associated with schizophrenia, mood disorders, PTSD, or dementia. (emphasis mine) 

“Our study suggests that off-label use of these drugs in older people should be short-term, and undertaken with caution,” said Dilip V. Jeste, MD, Estelle and Edgar Levi Chair in Aging, Distinguished Professor of Psychiatry and Neurosciences, and director of the Stein Institute for Research on Aging at UC San Diego.

"Results of the five-year study led by Jeste, who is also current president of the American Psychiatric Association (which was not involved in this research), showed that within one year of treatment, one-third of the patients enrolled in the study developed metabolic syndrome (medical disorders that can increase the risk of cardiovascular disease or diabetes). Within two years, nearly a quarter of the patients developed serious adverse effects and just over half developed non-serious adverse effects." here

The FDA approved indications for the 4 drugs used in this study are here

All of the drugs used in this drug trial have black box warnings from the FDA for causing increased mortality for elderly with dementia. The UC San Diego article states, some of the drugs, "carry FDA warnings."  The actual number of participants enrolled in the trial was 406, according to the ClinicalTrials.gov website; why would the the UC San Diego announcement state there were only 332?  PTSD and mood disorders are not listed with the conditions participants were to be treated for on the Clinical Trials website; schizophrenia, Alzheimer's Disease, and dementia are the conditions listed. The only one that is an FDA approved condition is schizophrenia.  The end points were safety and efficacy, which is standard for an "investigational" drug trial, Clinical Trials.gov states this was an investigational Phase 1 trial for the first few years of the trial.  

On October 18, 2012 "Active Control" was deleted from the list of  design characteristics for this study. The responsible party, Dilip V. Jeste, and UCSD was changed to "sponsor" on the same  date.  On April 11, 2009 the Seroquel arm was discontinued, and the answer for the  "accepts healthy volunteers" question was changed from "NO" to "Yes."  A Data Monitoring Committee was also added at the same time.  On February 29, 2008 the classification for this trial was changed from a Phase 1 drug trial to a Phase 4 drug trial; The lead sponsor was changed from being listed as the NIMH to being listed as UCSD; and Dilip V. Jeste, at UCSD, was listed as now being the responsible party, usually the responsible party the lead investigator, would also be the lead author, but in this case Dilip V. Jeste, the President of the American Psychiatric Association, is said to be the lead investigator but is not the lead author.  This study started with The Veterans Medical Research Foundation as the lead sponsor, then the lead sponsor was the NIMH, and upon the study's conclusion, the VMRF is once again listed as the lead sponsor and the NIMH is listed as a collaborator. 

"The bottom line is no solid evidence-based treatment exists for psychosis or agitation in dementia. Atypical antipsychotics carry a black-box warning for increased risk of death and cerebrovascular events in dementia, although typical antipsychotics appear no safer." Thomas W. Meeks, M.D. and Dilip V. Jeste, M.D. in Beyond the Black Box: What is The Role for Antipsychotics in Dementia? 2008

via Physicians Postgraduate Press:
Use of Clinical Markers to Identify Metabolic Syndrome in Antipsychotic-Treated Patients

Hua Jin, MD; Jonathan Meyer, MD; Sunder Mudaliar, MD; Robert Henry, MD; Srikrishna Khandrika, PhD; Danielle K. Glorioso, MSW; Helena Kraemer, PhD; and Dilip Jeste, MD

J Clin Psychiatry 2010;71(10):1273–1278

10.4088/JCP.09m05414yel

Copyright 2010 Physicians Postgraduate Press, Inc.

Objective: Metabolic syndrome (MetS) is prevalent among antipsychotic-treated patients; however, in psychiatric clinics, scarce resources often limit the feasibility of monitoring all 5 criteria that are necessary for diagnosing MetS. As one goal of the MetS definition is to facilitate the clinical identification of insulin-resistant individuals, other biomarkers of insulin resistance have been explored. However, there are relatively few data from antipsychotic-treated patients, especially on the association between these markers and the clinical MetS diagnosis.

Method: We analyzed data from 196 psychiatric patients over age 40 years enrolled in an ongoing study of antipsychotic-related metabolic effects that began in August 2005. here

Black Box Warning from The U.S. Department of Health and Human Services FDA

Public Health Advisory: Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances

4/11/2005

The Food and Drug Administration has determined that the treatment of behavioral disorders in elderly patients with dementia with atypical (second generation) antipsychotic medications is associated with increased mortality. Of a total of seventeen placebo controlled trials performed with olanzapine (Zyprexa), aripiprazole (Abilify), risperidone (Risperdal), or quetiapine (Seroquel) in elderly demented patients with behavioral disorders, fifteen showed numerical increases in mortality in the drug-treated group compared to the placebo-treated patients. These studies enrolled a total of 5106 patients, and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia). read the rest here

 via Physician's Post Graduate Press:

Comparison of Longer-Term Safety and Effectiveness of 4 Atypical Antipsychotics in Patients Over Age 40: A Trial Using Equipoise-Stratified Randomization

Hua Jin, MD; Pei-an Betty Shih, PhD; Shahrokh Golshan, PhD; Sunder Mudaliar, MD; Robert Henry, MD; Danielle K. Glorioso, MSW; Stephan Arndt, PhD; Helena C. Kraemer, PhD; and Dilip V. Jeste, MD

J Clin Psychiatry

10.4088/JCP.12m08001

Copyright 2012 Physicians Postgraduate Press, Inc.

Objective: To compare longer-term safety and effectiveness of the 4 most commonly used atypical antipsychotics (aripiprazole, olanzapine, quetiapine, and risperidone) in 332 patients, aged > 40 years, having psychosis associated with schizophrenia, mood disorders, posttraumatic stress disorder, or dementia, diagnosed using DSM-IV-TR criteria.

Method: We used equipoise-stratified randomization (a hybrid of complete randomization and clinician’s choice methods) that allowed patients or their treating psychiatrists to exclude 1 or 2 of the study atypical antipsychotics due to past experience or anticipated risk. Patients were followed for up to 2 years, with assessments at baseline, 6 weeks, 12 weeks, and every 12 weeks thereafter. Medications were administered employing open-label design and flexible dosages, but with blind raters. The study was conducted from October 2005 to October 2010.

Outcome Measures: Primary metabolic markers (body mass index, blood pressure, fasting blood glucose, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), percentage of patients who stay on the randomly assigned atypical antipsychotic for at least 6 months, psychopathology, percentage of patients who develop metabolic syndrome, and percentage of patients who develop serious and nonserious adverse events.

Results: Because of a high incidence of serious adverse events, quetiapine was discontinued midway through the trial. There were significant differences among patients willing to be randomized to different atypical antipsychotics (P < .01), suggesting that treating clinicians tended to exclude olanzapine and prefer aripiprazole as one of the possible choices in patients with metabolic problems. Yet, the atypical antipsychotic groups did not differ in longitudinal changes in metabolic parameters or on most other outcome measures. Overall results suggested a high discontinuation rate (median duration 26 weeks prior to discontinuation), lack of significant improvement in psychopathology, and high cumulative incidence of metabolic syndrome (36.5% in 1 year) and of serious (23.7%) and nonserious (50.8%) adverse events for all atypical antipsychotics in the study.

Conclusions: Employing a study design that closely mimicked clinical practice, we found a lack of effectiveness and a high incidence of side effects with 4 commonly prescribed atypical antipsychotics across diagnostic groups in patients over age 40, with relatively few differences among the drugs. Caution in the use of these drugs is warranted in middle-aged and older patients.    here

via ClinicalTrials.gov:

Side Effects of Newer Antipsychotics in Older Adults

Purpose

This study will compare four atypical antipsychotic medications in terms of the risk of specific side effects each of them presents in middle-aged and elderly individuals.

Condition                                                Intervention                                                   Phase
Schizophrenia                                         Drug: Aripiprazole                                         Phase 4
Alzheimer's Disease                                Drug: Olanzapine
Dementia                                                Drug: Risperidone


Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Effects of Newer Antipsychotics in Older Patients

Detailed Description:

Atypical antipsychotic medications introduced within the last decade have been used increasingly for the treatment of several types of psychotic disorders and severe behavioral disturbances in older individuals. This trend is primarily due to a decrease in side effects caused by the new medications, as compared to conventional neuroleptic medications. There is a lower risk for developing tardive dyskinesia and extrapyramidal symptoms, both of which are movement abnormalities, with new antipsychotic medications. However, there has been a growing concern that the newer medications can cause a different set of potentially serious adverse side effects. Specifically, they may cause long-term metabolic, cardiovascular, and cerebrovascular effects, which may result in weight gain, diabetes, or stroke. This study will compare four atypical antipsychotic medications in terms of the risk of metabolic, cardiovascular, and cerebrovascular side effects that each presents in middle-aged and elderly individuals.

Participants in this open-label study will be randomly assigned to receive one of three atypical antipsychotic medications: aripiprazole; olanzapine; or risperidone. Although assignment is random, a technique that may reflect the participant's own interests or the researcher's knowledge of relevant participant characteristics will be used to assign the participant to a medication. Dosing will be determined by each participant's psychiatrist. Participants will be followed for up to 5 years to assess the side effects of the study medications, with study visits at baseline, Week 6, and every 3 months thereafter.

Ages Eligible for Study: 40 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

Criteria
Inclusion Criteria:
DSM-IV diagnosis of a disease or disorder that requires treatment with an atypical antipsychotic medication

Exclusion Criteria:
N/A here

photo credit Just Ducks