Does the AACAP have an ethical, medical rationale for prescribing neuroleptics to kids? No, it does not.

It appears that prescribing neuroleptic drugs for children and youth with emotional and behavioral issues has proceeded without evidence the drugs even treat emotional and behavioral problems in the pediatric population. Worse than this, prescribing psychoactive drugs off label has become a "standard clinical practice" without any evidence the drugs are safe or effective for children and teen-agers. What is truly frightening: the wider medical community use these wholly unethical standards of "care." While off label prescriptions are not unusual in medicine, off label use of drugs requires sufficient evidence of safety and effectiveness to be considered an ethical standard of medical care! It is apparent that prescribing children and teen-aged youth neuroleptics and other psychotropic drugs has proceeded without even minimal evidence, forget definitive evidence, to support or validate the practice. Why are we using what are dangerous, teratogenic drugs to treat kids' emotional and behavioral symptoms?

Medical treatment in which drugs are used in ways that are not FDA approved, and not supported with definitive evidence of the drugs' effectiveness or safety is accurately described as "experimental use" of the drugs; not something that should be considered a "standard clinical practice!" Atypical antipsychotics or "Second Generation Antipsychotics," are neuroleptic drugs which alter many physiological processes. Although some of this class of psychotropic drugs have been FDA approved for pediatric use, for specific psychiatric diagnoses and/or behavioral symptoms, the approval was not based on what a reasonable person would consider to be robust data of safety or efficacy, much less effectiveness. The fact is, in real world practice, neuroleptics are prescribed to kids much more off label than they are prescribed for FDA approved conditions or symptoms. In effect, experimental use of teratogenic drugs on children and youth, i.e. human experimentation, is now a "standard practice" in psychiatry.

When children and youth are prescribed psychotropic drugs off label, particularly neuroleptics, what protection do they have from harm? In effect, they have little to none; using a "standard of care" is an affirmative defense against a malpractice claim for damages, whether it is an ethical standard or not...It is unconscionable that most of the prescriptions for neuroleptic drugs are for off label use; why is this ethically questionable standard of care casually accepted by the wider medical community? Drugs that have not been tested and clinically demonstrated to be safe and effective for children and youth, should not be widely prescribed in standard practice! Nonetheless, off label prescriptions for neuroleptic drugs continue to account for the largest percentage of prescriptions for neuroleptics in the pediatric population. Neuroleptic drugs cause a wide variety of adverse cognitive effects, i.e. brain damage, neurological impairments and metabolic dysfunction; they cause diseases---these are direct, adverse effects of neuroleptic drugs, it is how they "work." This "standard practice" has been investigated by the U.S. Senate at least three times in my memory, each investigation has quantified an increase in the numbers of children being prescribed teratogenic drugs and fraudulent Medicaid claims being paid. What is not quantified is the number of children who are disabled and killed. Using poor children on Medicaid who have behavioral and emotional problems as unwitting guinea pigs is now considered an ethical standard of care...

The standards of care, treatment algorithms, and practice parameters were developed by consensus, a quasi-democratic political process, not derived from clinical research data.  Psychiatric professionals who are members of the American Academy of Child and Adolescent Psychiatry, and the American Psychiatric Association, then disseminated these unethical standards in their professional literature, in symposiums and continuing medical education programs.  Psychiatrists in the AACAP really would like the NIMH to fund research to hopefully gather the supporting evidence that will validate the standards of care in widespread use (thanks to the AACAP).  These are the standards of care that the AACAP is simultaneously vehemently defending as "necessary medical treatment;" implying it is ethical evidence-based treatment...

The AACAP is acknowledging that the evidence for the ethical medical prescription of teratogenic drugs off label to children and youth is STILL needed---decades after the AACAP started using neuroleptic and other psychotropic drugs off label to "treat" the emotional and behavioral problems children have---decades after it became a "standard prectice." The AACAP implemented a standard of care absent the evidence required to validate it as a standard. It is not ethically possible to implement the use of psychiatric drugs "off label," i.e. experimentally, as a standard treatment without definitive evidence of safety and effectiveness. Obviously, this standard was implemented  precipitously; without regard for patient safety. It is a standard of care that is not based on sound scientific principles, or actual evidence; it is absent the use of ethical medical judgement altogether...

Off label prescription drugs that are unsupported by evidence that the treatment is safe and effective, is experimental by definition. Medicaid, in theory, functions like insurance for the poor.  Why are fraudulent claims for non-covered, non-approved off label prescriptions drug costs paid? It is only psychiatric drugs that are ALWAYS paid for without question, by the Medicaid program.

Billions of taxpayer dollars have been defrauded from the American people since the vast majority of off label psychotropic drugs prescribed are written for poor children on Medicaid. We pay for it even though it is not ethical, even though it is fraudulent, even though it disables and kills children.

A few months ago, the AACAP applauded the AMA for seeking guidance from the NIMH about the off label use of neuroleptics for children and youth with emotional and behavioral problems.

via the AACAP:
The American Academy of Child and Adolescent Psychiatry (AACAP) applauds the American Medical Association (AMA) for adopting a report recommending the National Institute of Mental Health (NIMH) assist in developing guidance for physicians on the use of atypical antipsychotic medications in pediatric patients, and encouraging ongoing federally funded studies on long-term efficacy and safety.

AACAP delegate to the AMA and member of the AMA Council on Science and Public Health, Louis Kraus, M.D., testified that the report discusses the complex issues surrounding the clinical use of these drugs and evaluates the data currently available.

There has been an increased use in atypical antipsychotic medications which when used appropriately can be an effective part of a comprehensive treatment plan for children with schizophrenia and bipolar disorder. However, these medications are increasingly being used "off label" when treating children and adolescents with other psychiatric disorders.

"Physicians and parents need more information about both the safety and efficacy of these medications, especially when they are used over an extended period of time," testified David Fassler, M.D., AACAP alternate delegate to the AMA.

Most research on the use of atypical antipsychotic medications on the pediatric population focuses on short term use, yet in clinical practice an increasing number of pediatric patients take these medications for many months or years.

"AACAP is pleased that the AMA is encouraging NIMH to conduct additional studies on these medications. We need to better understand both the short term and long term effects on our patients," said AACAP President, Martin J. Drell, M.D.

The AMA report is supported by the American Psychiatric Association, American Academy of Psychiatry and the Law and the American Pediatric Association. here

Does the AACAP have an ethical, medical rationale 

for prescribing neuroleptics to kids off label?
No, it does not.  

via REPORT OF THE COUNCIL ON SCIENCE AND PUBLIC HEALTH CSAPH Report 1-I-12:
 a couple excerpts:

"The proportional use of atypical antipsychotics was 16% of treatment visits in 1995, but such use had surged to 93% of treatment visits by 2008. In two-thirds of these visits, the prescription was for an off-label use.5

"Antipsychotic treatment rates among privately insured youth ages 6 to 17 increased steadily from 1996 (0.21%) to 2006 (0.90%) with higher rates among those ages 13 to 17.7 The annualized rate of use in such patients ages 2 to 5 more than doubled between 1999 and 2007 to 0.16%, most commonly to help manage pervasive developmental disorder or mental retardation.8

"More than 4% of Medicaid youth ages 6 to 17 filled at least one prescription for an antipsychotic in 2004, with 75% of these being for off-label uses.7 A number of children under 6 years of age enrolled in Medicaid programs receive ongoing treatment with antipsychotic medications.9,10" (page 3)

Discussion
Although certain atypical antipsychotic drugs are FDA-approved for specific uses in pediatric patients, the majority of prescribing (70 to 75%) is off-label for these drugs. Head-to-head comparisons of atypical antipsychotic drugs for off-label uses are few, and evidence from placebo-controlled trials for off-label use suggests that efficacy differs between drugs. Accordingly, one cannot anticipate that a “class effect” exists for atypical antipsychotics with respect to any specific clinical use or indication.  here

from a letter from Citizens for Responsible Care & Research, Inc. to The Presidential Commission for the Study of Bioethical Issues Public Comment in Response to: Federal Register 76:41 (March 2, 2011) pp. 11482-11483:

a couple of excerpts:
"Part 1: Suggestions To Consider
As suggested in the Federal Register notice, in order assist the Commission in developing a thorough  understanding of the adequacy of current U.S. and international standards for protecting the health and well-being of human subjects in scientific studies supported by the federal government, we refer the Commission to the public comment of CIRCARE vice president Gerald Schatz, J.D., in which he describes international law, requirements of which the bioethics community is apparently oblivious. For your convenience we reproduce the relevant portion of his comment:
                “There is the International Covenant on Civil and Political Rights the United States
                ratified in 1992 and it makes informed consent an absolute requirement, no exceptions,
                not even in emergencies, subject to those normal legal fictions of consenting for the
                incapacitated patient to medical care and so forth. Additionally, the Geneva Conventions
                and Additional Protocols to the Geneva Conventions make research very, very difficult
                or prohibited altogether for those individuals who are caught up in the war and armed
                conflicts.” (2)

Over the past several years the International Compilation of Human Subjects Protections posted on the OHRP website has been significantly strengthened by additions of the International Covenant on Civil and Political Rights, the Geneva Conventions and Additional Protocols to the Geneva Conventions. (3) A persistent problem, however, has been a lack of OHRP guidance on the significance and applicability of this law. An additional difficulty seems to be that not only is there failure to acknowledge this law and its applicability inside and outside the U.S., it is almost surely the case that neither OHRP nor FDA are adequately resourced to implementation of this law.(sic) Consequently we urge the Commission to recommend information about this law be distributed to appropriate U.S. agencies, research partner governments, research institutions, commercial research sponsors, and appropriate NGOs. Links to the Michigan State University faculty response as drafted by Gerald Schatz to the 2005 OHRP request for comment on equivalent protections as described above, two legal articles, and electronic versions of the law in question are provided in the references at the end of this document. (3)"

"CIRCARE holds FDA and OHRP in high regard and commends staff for their accomplishments. Practically speaking, our post hoc system means that failures of protections occasion the bulk of regulatory oversight of institutions or individuals. The opening paragraph of a typical FDA warning letter refers to an inspection conducted many months earlier and addresses objectionable conduct in one or more clinical investigations which ended years previously. (4) The definition of the verb “to protect” is “to cover or shield from exposure, injury, damage, or destruction; (to) defend.” (5) We challenge the Commission to consider if is it reasonable to believe post hoc action provides meaningful protection of human subjects in research."

"A typical FDA warning letter offers two challenging paradoxes the Commission should to consider. Prior to 2007 boiler-plate language informed warning letter recipients that FDA inspections are conducted under a program, one aspect of which is to ensure the integrity of data submitted in drug or medical device marketing applications, the other aspect of which is to ensure that human subjects are protected from undue hazard or risk in clinical investigations. More recently this language has been revised to state that inspections are conducted pursuant to FDA’s Bioresearch Monitoring Program to evaluate the conduct, i.e. data integrity, and to ensure that the rights, safety, and welfare of human subjects have been protected. (op sit, p.1) The past tense of the copulative verb “have been” illustrates the paradox of a post hoc system in which the regulator proposes to protect the welfare of human subjects by inspection and enforcement after the fact." here

photo credit
4-16-2013

Antipsychotic Use by Medicaid-Insured Youths: evidence of criminal prescribing practices

Average rate of gray matter loss: evidence of neuroleptic drug-induced brain damage.

The more drugs you've been given, the more brain tissue you lose. What exactly do these drugs do? They block basal ganglia activity. The prefrontal cortex doesn't get the input it needs and is being shut down by drugs. That reduces the psychotic symptoms. It also causes the prefrontal cortex to slowly atrophy. 

~ Dr. Nancy C. Andreasen, New York Times, Sept. 16, 2008

Both the older and the atypical neuroleptics shrink brain tissue during routine clinical exposure.

~ Dr. Peter R. Breggin, Brain Disabling Treatments in Psychiatry (2008) 

ARTICLES   |   March 01, 2013 

Antipsychotic Use by Medicaid-Insured Youths: Impact of Eligibility and Psychiatric Diagnosis Across a Decade

Julie Magno Zito, Ph.D.; Mehmet Burcu, M.S.; Aloysius Ibe, Dr.P.H.; Daniel J. Safer, M.D.; Laurence S. Magder, Ph.D.

Psychiatric Services 2013; doi: 10.1176/appi.ps.201200081

Author and Article Information

Dr. Zito and Mr. Burcu are affiliated with the Department of Pharmaceutical Health Services Research and Dr. Magder is with the Department of Epidemiology and Public Health, University of Maryland, 220 Arch St., Room 01-216, Baltimore, MD 21201 (e-mail: jzito@rx.umaryland.edu).Dr. Ibe is with the School of Community Health and Policy, Morgan State University, Baltimore.Dr. Safer is with the Department of Psychiatry, Johns Hopkins University, Baltimore.

Copyright © American Psychiatric Association

a couple of excerpts:

Conclusions

"The expansion of antipsychotic medication use from 1997 to 2006 among Medicaid-insured youths was most prominent among those qualifying with low (SCHIP) and very low (TANF) family incomes. This was the case even though the most impaired youths—those in foster care or those receiving SSI—had distinctly higher levels of antipsychotic drug use within each study year. Factors contributing to this antipsychotic use pattern included the expanding SCHIP and TANF populations, the increased use of antipsychotics among youths enrolled in SCHIP and TANF, and the increased use of antipsychotic medication for behavior disorders over the decade. Likewise, although youths with diagnoses of schizophrenia and other psychotic disorders and pervasive developmental disorders had the highest rates of antipsychotic medication use, youths with externalizing behavior disorders far outnumbered those with these less common conditions and constituted the largest group of utilizers of antipsychotic medications."

"Methods: The authors analyzed computerized administrative claims data for 456,315 youths aged two to 17 years who were continuously enrolled in Medicaid in a mid-Atlantic state in 1997 (N=159,171) and 2006 (N=297,144)."

In 1997 a total of 615 kids with no diagnosis were prescribed neuroleptic drugs in this sample. More than twice as many kids, a total of 1,481 were prescribed a neuroletic drug in 2006, despite the fact they had no psychiatric diagnosis which would indicate a need for such a prescription!

What the above represents is only a small percentage of the number of fraudulent claims which were submitted to Medicaid for payment, i.e. fraud. Obviously, the civil and criminal penalties paid by the pharmaceutical industry for illegally marketing these drugs is not going to stop the fraud. The unethical medical practitioners are defending their "professional privilege" to use these drugs absent evidence the drugs "treat" the conditions the drugs are prescribed off label for. It is the prescribers whose unethical prescribing of these teratogenic drugs to children are guided by the APA and AACAP practice parameters and treatment algorithms who must be stopped.  Standard practices originally protected patients, now they serve to protect the unethical behavior of the professionals who use them as an affirmative defense for what is not only medical malpractice, but Human Experimentation; the current standard in mental health care for kids on Medicaid.  



hat tip: Allen Frances, M.D.

@allenfrancesmd It doesn't explain the lack of #medicalethics it takes to Rx drugs that cause a myriad of neurological cognitive impairments
— Becky (@yobluemama2) March 8, 2013

@narcotic_repose Pharma fined heavily for illegal off-label marketing,but continues because antipsychotic sales an outrageous $18 bil/yr
— Allen Frances (@AllenFrancesMD) March 8, 2013

@allenfrancesmd @narcotic_repose Pharma wouldn't be successful w/o unethical doctors Rxing neuroleptics for behaviors others find annoying!
— Becky (@yobluemama2) March 8, 2013

PRESCRIPTION PSYCHOTROPIC DRUG USE AMONG CHILDREN IN FOSTER CARE 

House Hearing,  2009

Special thanks to Methodius Isaac Bonkers of Bonkers Institute of Nearly Genuine Research for the graphic and the quotes at the beginning of this post.

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Now that is crazy!

It is not surprising that the bio-disease psychiatric treatment paradigm has failed; it is  pseudo-science; based on biased assumptions, and errors of attribution.  The newest fad or incarnation is psychopharmacology.  It is hailed by those with a myopic devotion to a bio-medical model steeped in the aforementioned biases and errors.  Psychiatry, in this bio-disease paradigm, is not grounded in any moral, philosophical, or scientific principles.  Indeed, it is exists in stark contrast as a gross departure from these principles; it is wholly contradictory to Medicine in the Hippocratic tradition.  It does not seem to honor or value, much less adhere to, the Hippocratic Oath to "First, do no harm..."   

Beyond comprehension is the lack of meaningful response from the medical and legal professions.   Failing to repudiate the gross departure from Ethical, Medical, Scientific, and Legal Principles by remaining silent  is to be complicit in the targeting of specific groups of vulnerable people for legally authorized 'special treatment.'  How is this not seen for what it is?!  It is using fear-based misinformation, i.e. propaganda, recruiting family and community advocates to 'educate' and inform on those targeted; it is legally classifying particular groups of people as being in need of 'special treatment.'  This are the exact same social control strategies which were used leading up to the Holocaust for God's sake!  The 'needed treatment' never cures or heals, it always debilitates and inevitably leads to death.  We have as a society, been duped by 'medical professionals' who have convinced us that the best way to help is to harm vulnerable children, adults, the elderly and traumatized veterans and to deprive them of fundamental Human Rights, and even their right to object.   Now that truly is crazy!  Silence becomes complicity.  Medical and Legal professionals have went along with psychiatry's fraudulent, unethical, coercive and manipulative methods which disable and kill; but never cure or heal.  Psychiatry's 'psycho' pharmacologists insist that some people must be forced to have 'special treatment' for the rest of their lives---which really means, until it kills them... 

Medical professions have witnessed the negligent care psychiatry provides to psychiatric patients for the iatrogenic, or 'physician caused' diseases, and the cognitive and neurological impairments, along with the emotional injuries  inflicted upon psychiatric patients in this "Standard of Care."   The standard is based on the biased opinions of psychiatrists and are rooted not in medicine, but in a social control system embedded in standards of care and entrenched within our Human Social Service System.  The Human Services System is steeped in Eugenics theory.  The Human Service system was started by Eugenicists, who acting under the guise of benevolent assistance, ( for the good of society) targeted individuals  and families in need of social services.  Those targeted, were selected due to the perception that they were considered 'genetically inferior.'  The  historical roots of psychiatry are inextricably linked with this Eugenics history.  Psychiatry has always relied on coercion and other social control strategies, including using misinformation.  Psychiatrists today are vehemently defending the practices which effectively rob psychiatric patients of their dignity, their autonomy, their Human Rights and their very lives.  Psychiatry is in effect, defending a RIGHT to cause iatrogenic illnesses and disabilities, including causing drug-induced death to their patients.  Physician caused homicide is blindly accepted by society---it is even 'legal;' as it was in Germany leading up to the Holocaust.

The obvious primary function served (intentionally or not) that the claim people who have a psychiatric diagnosis 'lack insight,' is that when the claim is believed; it effectively deprives the person of ANY and ALL means of defending themselves against psychiatric assault.  Iatrogenic harm is common, and the harm is intentionally and purposely inflicted upon patients by psychiatrists.  It is a travesty that these so-called doctors claim it is 'necessary medical treatment' since their treatment doesn't actually 'treat' an identified disease;  but in fact causes a myriad of disabling and fatal diseases.  So drug-induced death is now an acceptable primary outcome achieved by Psychiatry with it's so-called "medical treatment."

Disability and Death are the new Recovery Standard

This is a gross abuse of power and medical privilege; based on an idea which is not even a validated hypothesis; yet is accepted as a basis to force treatment while depriving a person of their Individual Rights, their liberty, and their physical health.   First it was just done to the 'schizophrenics' now it is children and teenagers with behavior issues, trauma victims, vulnerable elderly, and now too also alcoholic/addicts who commit crimes or get federally funded treatment.  Psychiatry has slowly widened the net for potential patients to act in loco parentis  for.   Psychiatry without conforming to the ethical principles of scientific research or medical practice, has been granted the Legal Authority to determine who NEEDS this special medical treatment which can be, addictive, disabling, and fatal.  What exactly about all of this is so desirable yet none of the ethical standards or societal norms are needed?  How can it be overlooked that this 'medical specialty' continues to drug people into states of disability and sudden or early death. Psychiatry claims to be treating diseases and chemical imbalances, when in reality their treatments are causing diseases and chemical imbalances that can  disable and kill psychiatric patients.   Now these drugs are the most 'popular' prescription drugs, and are prescribed to all ages; prescribed off label for avirtually any and every psychiatric diagnosis, and even, absent any psychiatric diagnosis!  

Psychotropic Drugs are the antithesis of  

'Medicine' in the Hippocratic tradition.

Psychiatry in the bio-medical paradigm of 'care'  lacks the support of ethical scientific research, but it is the lack of respect for psychiatric patients which inflicts untold emotional harm upon patients and family members alike; and rightly causes deep mistrust.   The underlying message patients and family members harmed by this disrespect is that psychiatric patients do not deserve to be respected, to be listened to, to be defended or protected; they do not even deserve to be told the truth.  Seems to me this is backwards--- how does believing a person has an illness and doesn't know they're sick, who needs others to act on their behalf, justify lowering standards of care and adopting treatment compliance as a primary measure of successful treatment?  This lowering of standards effectively sends the message: Psychiatric patients are not worthy of respect. 

Now that is crazy!

This failure to respect the dignity and humanity of psychiatric patients is allowed, accepted and even encouraged by some as a valid ethical medical practice!  Coercion, and manipulative abuse of  authority are dishonest, unethical behaviors; in any other context, the behaviors  are easily recognised as bullying behaviors.  People are told what perhaps is a gross exaggeration, and may not even be true at all. People are told that the psychiatric diagnosis that they are labeled with means they have a disease which requires medical treatment for the rest of their life, because the disease cannot be cured.  This is fraud.  It is without empirical data to validate the claim; without evidence that supports the Standard Practice of using neuroleptic drugs automatically as a first-line treatment. Standards are to be derived from the scientific evidence; not developed and implemented as part of the Standards of Clinical Care, by consensus, without supporting evidence.  Particularly when there is ample evidence the drugs are inefficacious for many, and have significant risks, including fatality.

One wonders how has the medical profession become willfully blind to iatrogenic disease, disability and death?  These are common real world outcomes of standard psychiatric treatment.  Patients are rarely warned of the risks for the harm ultimately caused to them by unethical practitioners.  It is also standard practice to avoid telling patients, family members and the general public the truth about the teratogenic nature of psychiatric drugs.  It is even more common to deny the adverse effects patients experience, or worse, attribute iatrogenic injury to the 'disease' supposedly being treated...How many in the medical profession are aware that psychiatric patients are routinely misled, manipulated and coerced?  As a matter of course parents are misinformed and pressured, coerced and worse, have their children taken from them for not consenting to giving them neurotoxic drugs---This is a gross abuse of medical and legal 'authority.'  In fact this practice does not adhere to any ethical or legal standards, it is tearing families apart.  Psychiatry, in effect, captures patients and robs them of the rights everyone else has. How is this not recognized as an utter lack of respect which strips people of  their human dignity?   How is it ethical or moral to drug people who are effectively politically and legally dis-empowered upon diagnosis? In effect, de-voiced.  

Psychiatric diagnosis is the "stigma"

I do not understand how inhumane unethical treatment of this type is accepted as a valid medical treatment.  How can it be medically or morally justifiable?   It is morally reprehensible that it as a direct result of standard 'medical treatment' a significant percentage of patients are disabled.  How can it be justified with a claim that it is, 'for their own good?'  One does not need to be a doctor to know that when far fewer patients are 'effectively treated,' than are disabled and die from the treatment; it is only an 'effective treatment,' if disability and death are the desired treatment outcomes.  Calling this medical treatment and making it 'Legal' doesn't make it efficacious; it certainly does not validate the claim that it is, 'medically necessary,'  and it certainly is not ethical... Why are psychiatric diagnoses used so casually in Courts of Law?  Rules of Evidence are ignored in Commitment proceedings.  Unlike any other medical illness, a psychiatric diagnosis can be adjudicated, instead of being verified or supported by the results from medical diagnostic procedures.  This legal determination becomes a part of a person's pemanent legal record.   Psychiatric diagnosis can be more accurately described and understood as a restriction of political and legal power.

A psychiatric diagnosis is a legal determination of one's diminished political power and legal status. Involuntary Treatment statutes lower evidentiary standards used in civil commitment proceedings; the lowered legal standards effectively deprive a person of their Human Rights.

If that isn't stigmatizing, I don't know what is!

It's criminal.

vintage ad found at practiceofmadness.com

first posted 5-5-2012 rewritten 7-2-2012

The FDA approval of Seroquel and Zyprexa for America's Children

TO APPROVE THE NEUROLEPTICS 

ZYPREXA AND GEODON 
HERE IS HOW THE FDA ADVISORY COMMITTEE VOTED: 

FDA Psychopharmacologic Drugs Advisory Committee Hearings

June 9 – 10, 2009

Prepared by S. Fleisher

On June 9 - 10, the FDA Psychopharmacologic Drugs Advisory Committee reviewed the requests from three pharmaceutical companies for medication approval for the treatment of schizophrenia and/or acute mania bipolar in pediatric populations. 

AstraZeneca Pharmaceuticals, LP, requested Seroquel (quetiapine fumarate) be granted FDA indication approval for the treatment of schizophrenia in adolescents ages 13 – 17 and acute treatment of bipolar mania in children and adolescents ages 10-17. 

Pfizer, Inc. requested Geodon (ziprasidone hydrochloride) be granted FDA indication approval for the acute treatment of bipolar mania in children and adolescents ages 10 – 17 years. 

Eli Lilly and Company requested Zyprexa (olanzapine) be granted FDA indication approval for the treatment of schizophrenia in adolescents ages 13 – 17 years of age and acute treatment of bipolar mania in adolescents ages 13 – 17.

On Wednesday, June 10, the Committee members reconvened. The morning began with a presentation by Kenneth Towbin, M.D., AACAP member and Chief, Clinical Child and Adolescent Psychiatry Mood and Anxiety Disorder Program of the NIMH. Dr. Towbin provided the Committee with an overview of the controversial diagnosis of bipolar disorder and the varying characterization of symptoms used to diagnose the disorder. Dr. Towbin stressed the fact that bipolar disorder is real and can be diagnosed in the pediatric population. He also indicated bipolar disorder is very rare in children and adolescents and that more children and adolescents suffer from severe mood dysregulation. The Committee thanked Dr. Towbin for his presentation and assistance in helping them understand the pediatric bipolar disorder diagnosis controversy. The Committee then continued their discussions and questioning of the data presented on Tuesday.

After thorough discussion, the Committee held the following votes. The Committee found that Seroquel had been shown to be effective (17 – Yes, 1-No) and acceptably safe (16 – Yes, 2 – Abstain) for the treatment of schizophrenia; and they found that Seroquel had been shown to be effective (17 – Yes, 1 – Abstain) and acceptably safe (13 – Yes, 5 – Abstain) for the acute treatment of bipolar mania. The Committee was concerned about the metabolic and cardiac side effects of this medication, specifically the increased weight gain, heart rate and blood pressure. The Committee additionally recommended labeling clarifications regarding the use of this medication only for the narrowly defined mania aspects of bipolar disorder and clear indication that this medication not be used for severe mood dysregulation such as chronic irritability, oppositional defiance and hyperactivity. (emphasis mine)

The Committee found that Geodon had been shown to be effective (12 – Yes, 4 – Abstain, 2 – No) for the acute treatment of bipolar mania but no conclusion was delivered regarding the safety of this medication (9 – Abstain, 8 – Yes, 1 – No). The Committee members that abstained were concerned about the lack of long-term data, high QTc prolongation intervals, higher rate of side effects in children ages 10 – 14, and unusual number of trial subjects that were lost in the follow-up phase. 

The Committee found that Zyprexa had been shown to be effective (11 – Yes, 5 – No, 2 – Abstain) and acceptably safe (10 – Yes, 4 – No, 4 – Abstain) for the treatment of schizophrenia; and they found that Zyprexa had been shown to be effective (17 – Yes, 1 –  Abstain) and acceptably safe (11 – Yes, 4 – No, 3 Abstain) for the acute treatment of bipolar mania. The Committee recommended the approval as a second line treatment and recommended labeling clarifications regarding the use of this medication for the narrowly defined mania aspects of bipolar disorder and clear indication that this medication not be used for severe mood dysregulation. The Committee was concerned about the high level of metabolic and cardiac side effects of this medication, specifically the increased weight gain. (emphasis mine)

AACAP members serving on the Committee included Rochelle Caplan, M.D., Semel Institute for Neuroscience and Human Behavior, UCLA; Masha Rappley, M.D., Michigan State University; Kenneth Towbin, M.D., National Institute of Mental Health; and Benedetto Vitiello, M.D., National Institute of Mental Health.

To view copies of the data and presentations provided during the hearing, please visit the FDA website. (the FDA website no longer has any of this information posted.)

The testimony that is referred to above:

***FINAL***

June 9, 2009

Psychopharmacologic Drugs Advisory Committee Meeting

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20857

Good afternoon, my name is Larry Greenhill, M.D., and I am President-elect of the American Academy of Child and Adolescent Psychiatry. Over the past 24 months, I have received research support or have worked on a consultant basis with Otsuka, Johnson & Johnson, Forest, Pfizer, and NIMH. I have both practiced child psychiatry, been federally supported to study long-term adverse events associated with psychotropic medication use, and been a member of AACAP for 30 years. AACAP is a professional medical association of 8,000 child and adolescent psychiatrists established in 1953. 

AACAP is the leading national medical association dedicated to treating and improving the quality of life for the estimated 7 - 12 million American youth under 18 years of age who are affected by emotional, behavioral, developmental and mental disorders. Bipolar and Schizophrenia are severe psychiatric illnesses which first appear in childhood and adolescence. No one treatment option works for all children and adolescents with these disorders so we support a wide array of treatment options being available.

Although a few clinical trials have suggested that these antipsychotic medications can be effective in pediatric populations, the lack of systematically collected safety data when youth are exposed for long periods of time, that may affect development strongly, indicates that large scale Phase IV studies need to be carried out. 

We ask the FDA Advisory Committee to carefully consider whether the number and scope of the clinical trials as well as the duration of the safety trials to date involving children and adolescents justifies the labeling changes being requested today. While these medications may be helpful and even life saving for some children and adolescents suffering with these disorders, there are significant metabolic and cardiac adverse events associated with their use. We advise the FDA not to approve the request for indications in these medications unless they are also requiring that children treated be entered into a registry. These registries can take advantage of large group-practice HMO settings where electronic health records and pharmacological prescription data can be aggregated and compared. The resulting systematically collected information on the risks and benefits of these medications as well as specific methods for effective monitoring of their associated side effects must be made available to the public before direct-to-consumer marketing should be permitted to occur.  (emphasis mine) 

We thank the FDA for the opportunity for the American Academy of Child and Adolescent Psychiatry to provide this testimony. 

via National Injury Board News article FDA Considers Psychiatric Drugs For Kids June 2009

on the AACAP website

source of medical monkeys 

Imagine: We have more in common than you realize

The brief phrases and sentences in quotation marks are those of a medical professional that I was fortunate enough to have a dialogue with.  I say 'fortunate,' because I can be abrasive and rude; I was during this conversation---However, the professional was willing to continue in spite of my rudeness...  The subject was the "off-label" prescribing of psychiatric drugs to children and the lack of Informed Consent.  


It is my opinion the reason the drugs are being so widely used is that Informed Consent is not happening a majority of the time.   The reason I have this opinion, is my own experience as the parent of a son who has been prescribed psychiatric drugs off label, and speaking to countless other parents who report the same experience and sense of betrayal due to not being informed of the known serious risks of the drugs by the medical professionals who prescribed them.  I sincerely doubt that so many children would be taking dangerous psychiatric drugs if parents were in fact being given appropriate, relevent unbiased information on both the diagnoses and the psychiatric drugs given to their child.


There is no doubt in my mind, that I would have never have consented to giving any neuroleptic, or 'antipsychotic' drugs to my son who was emotionally and behaviorally disturbed due to being the victim of a violent crime.  There is no way in hell I would have consented, much less, given him the drugs myself--IF I had been told what was known about the drugs at the time they were prescribed.  I had to learn through research I have done on my own....It is one of my greatest sorrows that in my ignorance, I made sure my son took the drugs prescribed... My overwhelming sense of betrayal is devastating; these drugs have caused my precious son further harm; and according to my son, further traumatized him.  The drugs have disabled my son; and there is no comfort in knowing that it is not my fault.  I relied on misinformation given to me by the prescribing medical 'professionals' who have acted unethically with impunity.


My opinions and observations on this topic should not be construed to be a judgement of the nameless professional quoted, or the quality of care the professional provides to patients---in truth, I know only that the conversation in fact occurred; and that it greatly disturbed me. 

" "off-label" use is legal and is not experimental use"

While "off-label"prescribing of the drugs is legal, the fact that a drug is being prescribed "off-label" means it has not been tested and approved for children and that fact is something a parent needs to be told in a dialogue which informs a parent about the nature of the diagnosis, what the potential risks, possible benefits, and what alternatives to the proposed drug are; including answering questions and providing additional sources for information in order to actually inform the parent.  Otherwise, it is not Informed Consent, but simply an assent.  What is happening in Real World practice is unethical, illegal and immoral:  Parents are not being fully informed, they are being misled, manipulated and coerced, by some.  

The fact is neuroleptic drugs have been in pediatric use for decades---without valid clinical research being the basis of this questionable practice.  Due to the lack of effectiveness, most patients are given one drug after another, or multiple drugs concomitantly attempting to find one or a combination of several which will alter or control an undesirable behavior.  Ultimately, professionals are treating a behavior, which is not life threatening, with drugs that cause iatrogenic injuries without sharing well documented risks, e.g. without Informed Consent. It is the very definition of human experimentation, covered under the US Code of Federal Regulations and International Law, i.e. the Nuremberg Code.  Calling it "off-label" prescribing, does not actually change the nature of what is being done; nor does it make what is being done in Standard Practice safe or ethical, or less experimental.  


Psychotropic drugs have the well known, documented risks of causing iatrogenic disabilities and sudden death.  The only plausible explanation for the prolific use of drugs with such serious risks being widespread is that Informed Consent is not in fact obtained.  It also explains why the parents whose children have been iatrogenically disabled or killed state that they had no idea their child could be disabled or die as a consequence of treatment.  Not fully informing patients or parents of the known risks inherent in treating non-life threatening psychiatric symptoms with drugs that have serious risks is unethical.  Failing to inform about these risks while telling both the child and the parent the drugs are treating a metaphorical disease to coerce compliance with treatment, is fraud.  Telling a person that a drug will effectively treat a mythological neuro-biological disease, that has never been identified is a deception intended manipulate a person's behavior when successful and detrimental to the patient, is the definition of criminal fraud...  


Not informing parents that the drugs alter normally functioning physiological processes none of which are known to be contributing to the undesirable behavior being treated while failing to inform of the risks for brain damage, heart damage, permanent neurological impairments, disability and death is Standard Practice.  Standard or not, this practice does not conform to the Ethical Guidelines for Informed Consent of the AMA; it violates a person's Constitutional Rights, and a Parent's Constitutional Right to make medical decisions for their child.  

"Not validated by thin air- but by extrapolation and empirical practice- much of medicine is still an art"


Since when does that mean people can be misled, coerced and manipulated in order to be 'effectively treated?'   The 'neuro-biological disease paradigm' that is being crammed down our necks, is derived from or more accurately survived the supposed end of the Eugenics movement.  All of the coercive manipulative psycho-education type of 'treatments' used in Standard Practice INCLUDING the Court Mandated treatment, using CPS, Police and the Courts is exactly how eugenics is done.  Here and now.   It was done in Germany by the Third Reich, it is also done, here and now, in this country.  


Lets remember, to be 'evidence-based' prescription practices for drugs treatment and recommendations for them should be derived from the Clinical Trial Data; not based solely on anecdotal evidence and a consensus of subjective opinions.   "Off label" prescriptions are (theoretically) to be based on some scientific empirical data. e.g. using a safe and efficacious drug to treat either a condition or a population for which the drug has not yet been FDA approved based on the fact that the drugs have been used effectively and safely to treat another diagnosis or population.  Off label prescriptions were not supposed to become Standard Practice just because prescribers have the 'legal' option! e.g. adult to pediatric use of drugs approved for adults or drugs approved for symptoms of psychosis prescribed to extinguish aggressive behavior.  In the case of neuroleptics, they are 'effectively treating' a minority of the patients who have psychosis for which the drugs were initially FDA-approved, a fact that should cause any reasonable person--including medical professionals to ask, "why are teratogenic drugs being used so prolifically and indiscriminately in Standard Clinical Practice?"


"TEOSS study- specific for early onset schizophrenia- doesn't account for use for atypicals 4 other diagnoses- eg mood disorders"


That is EXACTLY my point!  Clinical standard practices and treatment protocols are not based on clinical trial evidence!  Clinical trials are being conducted to validate standard practice already in use--which is backwards--and driven by the growing criticism of psychiatry's qquestionable claims and methods and the harm being done to people who permanently disabled and die as a result or it.


"you are citing ONE small study- extensive database on neuroleptics"


Apparently, without even realizing it, the doctor is making my point.  TEOSS doesn't account for the widespread use of neuroleptic drugs in the pediatric population; no studies do. There is no ethical medical rationale or evidence base supporting use of the drugs in the pediatric population, nonetheless, it has been standard practice for decades.  The purpose of the TEOSS Drug Trial was to validate the Standard Practice of using the the newer Atypical drugs as First Line treatment for early on-set schizophrenia; to show that the newer more expensive "Atypicals" were safer and more effective, than the older, cheaper drugs.  The results?  The newer drugs are not safer, nor are they more effective.  A small percentage of the patients were effectively treated--12%.   Significantly, the newer drugs tested in TEOSS were subsequently FDA approved for pediatric use based on research conduted in other countries...


How many parents whose children are given these drugs--for any diagnosis--are told that more than 1 but less than 2 out of 100 treated may die; or that 50 % percent of the children who take neurolepic drugs are expected to develop Tardive Dyskinesia, an untreatable neurological condition which can be permanent and disabling; even if the drug is stopped?  I have not met a single one yet!  I am appalled and totally disgusted when parents tell me of the high cholesterol, obesity, diabetes and heart issues their child has; yet are unaware that these are known adverse effects of the drug prescribed to their child! 

"Truth is about risk vs benefit-- no intervention in medicine is 100 % risk free"

Why is it that instead of responding to issues of Informed Consent and the lack of EVIDENCE justifying prescribing psychiatric drugs for behavioral or social problems using what are teratogenic drugs, every single medical professional I have encountered has avoided the issue altogether, or pointed out that there is no risk-free medical treatments? Rationalization and justification are avoidance techniques/behaviors.  Once a professional gets to the point that they cannot rationally put forth a valid argument defending their opinion; that is, an evidence-based defense for "off-label" prescribing of psychiatric drugs; or even validate the FDA-approved uses, it becomes crystal clear:  It is, it appears, because they NEVER considered that relying on "peer-reviewed" journals for information may mean they are misinformed!  If professionals rely on professional journal articles which offer a biased reporting of the data, and use Treatment Protocols and algorithms based on a consensus of subjective opinions instead of empirical data, they are not serving their patient's best interest. The reality is: the recommendations from psychiatry's expert consensus guidelines on the diagnosis and treatment of psychiatric diagnoses are rarely supported by empirical evidence of diagnostic validity or treatment effectiveness and safety; but do provide effective support to an extremely successful marketing agenda... 


I can understand why professionals would rely on these sources; however, in light of what is now common knowledge about the basis, e.g. validity, of these sources, it is unacceptable for professionals to continue to unquestioningly rely upon them.  Some professionals purposely avoid examining their own treatment of patients in this manner due to confidence in their peers; but patient trust and medical ethics are not built on a professionals confidence in their peers, or risk-free treatments.  It is based on ethically providing competent and therapeutic care with due diligence of duty.  Patients deserve to be told the truth about what their diagnosis is based upon, and factual information about the possible benefits and potential risks of the treatment their doctor is recommending!  When the patient is a child, their parents deserve to be given accurate information so that they can perform their sacred duty to protect their own child.

It is about the flawed trial designs, the incomplete, biased reporting of the evidence derived from clinical trials published in "peer-reviewed" professional journals that medical professionals rely upon.

It is also about using one's critical thinking skills, individual professional responsibility, and medical ethics.  It is about understanding and relying upon sound ethical principals to guide one's own professional assessment of relevant information.  Altogether, these flaws require that a professional  never assume that a "peer-review" process replaces the need for critical analysis of the actual scientific data. The INTEGRITY of the Medical Profession has been seriously damaged, and continues to be eroded by the American Psychiatric Association's failure to police the unethical conduct of individual members who continue to be considered Key Opinion Leaders.

The APA has failed to hold individual psychiatrists accountable; especially those whose outrageous violations of the Hippocratic Oath and their failure to use sound, ethical scientific standards when conducting academic research involving Human Subjects.  These same 'Lead Researchers" base Practice Parameters and Treatment Algorithms upon consensus of subjective opinions, not the empirical data derived from their own research.  These standards are supposed to be supported by subjective observations, and based on the data; not based on subjective opinions, and contradictory to the scientific data!  


It is a evident that the diminishing credibility of psychiatry is due to the laissez faire manner in which it develops it's 'standard practices,' and it's unwillingness to hold unethical researchers accountable, or even to retract research articles which have been discredited and invalidated from it's own 'evidence' base!  Ultimately, this blind-eye approach to the conduct of it's members, while continuing to rely on their seriously flawed methodology and corrupt work products is what continues erode trust, and fuel the loss of integrity of psychiatry as a medical specialty.  


Doctors who are medical specialists or generalists rely on the corrupt information generated by a relative few unethical psychiatric researchers; researchers who are well-funded and have serious conflicts of interest, and whose work often lacks validity; to their own patient's detriment.  This lack of professional integrity is not in any patient's best interest; and has an impact on every patient's best interest.

The regulatory failure in the FDA approval process, is due to conflicts of interest and the same ethical failures which infect academic research.  Another failure of the FDA however, ensures that some of the lax ethics in research and prescribing of psychiatric drugs are easier to dismiss and disguise; or worse, remain undiscovered rationalized and/or justified away.  The failure to which I am referring is the failure to require that Medical Professionals report adverse events, including death, to the AERS data base once a drug is FDA-approved.  The data from which one would more accurately assess risck/benefit of a particular drug.  It would be necessary to collect adverse events data from Real World clinical practice of FDA approved drugs...  Basing risk/benefit profiles solely of FDA-approved prescription drugs on the clinical trial data and anecdotal evidence is short-sighted, fundamentally flawed and NOT scientific.  It is no doubt contributing to the further corruption of the evidence base itself.  The data from Real World clinical practice is germane to both the efficacy and the safety of any and every FDA-approved drug.  This adverse event data is not being collected; it is not required of medical professionals to report it; and I, for one do not believe it is an 'oversight' or an 'accident.'

I have spent hours examining this data base, and what is frighteningly clear to me is that only a minority of the drug-induced deaths, drug induced iatrogenic illnesses and disabilities; and drug induced life-threatening emergencies listed are reported by medical professionals who prescribed the drugs which caused the 'adverse events.'  The majority of the deaths are  reported by attorneys or family members; not prescribers.   Another significant, morally reprehensible fact which is evidence of an ongoing tragedy and the numerous aforementioned regulatory and ethical failures; is the number of infants and children under six listed. 

a blessing and a hopeful prayer from the professional:

"We have more in common than you realize- 

transform that anger into passion for change- 

more sustaining and healing"

It is my sincere hope that we all come to know 
we have more in common than we are now aware of...

Imagine that...

 first posted 12-9-2011photo credit