Psychiatry: societal values it has to pursue

retrainthebrain.com

This article reports on the first of five 2-day workshops held at the Hastings Center

Understanding the agreements and controversies surrounding childhood psychopharmacology

Erik Parens and Josephine Johnston

Erik Parens parense@thehastingscenter.org

The Hastings Center, 21 Malcolm Gordon Road, Garrison, New York 10524, USA

an excerpt:
As Benedetto Vitiello observed, we can all agree that, to the extent that medicalizing childbirth saves the lives of women and children, it is good; similarly, we can agree that labeling political dissenters as mentally ill (a form of medicalization that occurred in the former Soviet Union) is bad. It was religious studies scholar, Sidney Callahan, who articulated the group's widely shared view that we need to get clearer about the difference between "good" and "bad" forms of medicalization.

Again, though, different WPs emphasized different points. Psychiatrist John Sadler, for example, argued that medicine's primary focus should be to treat non-moral problems and that other social institutions (education, religion, criminal justice) should address the moral problems that too-often have crept into DSM's and psychiatry's ambit (e.g., Conduct Disorder): As he put it, "The mental health field should draw stricter boundaries between mental disorders and vice." Sadler believes that, as we define more and more moral problems as medical problems, we confuse the public about what he takes to be the fundamental difference between "badness" and "madness," between wrongful or criminal conduct and mental illness. Philosopher Bonnie Steinbock suggested that, whatever the conceptual difficulties with the distinction between "bad" and "mad," it would be pragmatically impossible to give it up entirely, since a criminal justice system requires us to be able to distinguish between criminal behavior – which is generally deserving of punishment – and behavior that, because it is the product of mental disorder, may not be deserving of punishment.

Some WPs, however, emphasized that we should use medicine if it helps achieve our aims, regardless of whether those aims are traditionally within the purview of medicine. Along the lines of psychiatrist Michael First above, psychiatrist Benedetto Vitiello argued: "Our society has decided that pain, suffering, murder, aggression are bad. Getting along with others, respecting the law are good. And these are the same values that medicine has to pursue. In some ways it's irrelevant if disorders are classified as illness or vice." here

It would be funny if it weren't so tragic...

Can the psychiatric profession engender respect for the law without demonstrating that respect for the law is valued by the psychiatric profession? Psychiatrists have been  active and a passive participants in a vast criminal enterprise. Participating in illegal marketing, research fraud, and then defrauding the American people of billions of dollars through the publicly funded Medicaid program, while using fraudulent claims as a means to coerce "treatment compliance." Psychiatrists have been misinforming patients, parents of children with behavioral and emotional difficulties and the general public about what is and is not known about mental illnesses; and were dishonest about the serious and even fatal risks of the psychotropic drugs they prescribe. Although the drugs are effective for some people, it does not justify prescribing dangerous drugs without significantly benefits to offset the serious risks. 

The massive amount of illegal marketing and Medicaid fraud would never have been possible without the complicity of the NIMH, the APA and the AACAP; particularly the individual psychiatrists who ignored the standards for scientific research, medical ethics, i.e. duty to do no harm; when implementing treatment protocols and algorithms that are then marketed as "evidence-based" Standards of Care. The standards of care recommend the drugs being illegally marketed simultaneously. 

The standards of care facilitate fraud. 

The widespread dissemination of psychiatry's treatment standards may be WHY so many children are being drugged for emotional and behavioral issues. FDA approved or off-label prescriptions how did the drugs recommended in treatment algorithms, practice paramenters and clinical care standards, become "standard" without robust evidence? 

Abuse, neglect, poverty, trauma and violence all exacerbate and  cause emotional and behavioral problems. Problem behaviors are often misguided attempts to meet unmet needs, a tauma reaction, or attempts to cope with traumatic harm. 

Pills can't fix poverty, pills do not prevent or treat the effects of malnutrition, pills do not heal traumatic injuries, pills do not give children the attention, concern, and compassion they deserve, or the consistent respectful guidance they require. Some may believe that psychopharmacological treatment helps children cope with the adverse effects of environmental and social stressors and the negative emotional and behavioral impact on children; there is no evidence that this is the case. Researchers may pursue a pill that can treat children's emotional and behavioral symptoms with environmental causes; but would such a pursuit be a political endeavor not a medical one. 

Would it be ethical? I think not... 

Video: Hastings researchers Erik Parens and Josephine John­ston intro­duce their report on chil­dren and psychiatry

More and more chil­dren in the United States receive psy­chi­atric diag­noses and psy­chotropic med­ica­tions — this is not news. With those increased rates of diag­no­sis and phar­ma­co­log­i­cal treat­ment come some­times intense debates about whether those increases are appro­pri­ate, or whether healthy chil­dren are being mis­la­beled as sick and inap­pro­pri­ately given med­ica­tions to alter their moods and behaviors.

• Why have the num­bers of chil­dren diag­nosed and treated increased, and what does this increase mean?
• Are chil­dren being overmedicated?
• Are sick chil­dren get­ting the care they need?

To bet­ter under­stand the­ses con­tro­ver­sies, The Hastings Cen­ter, an inde­pen­dent bioethics research insti­tu­tion, with a grant from the National Insti­tute of Men­tal Health, con­ducted a series of five work­shops over the course of three years that brought together clin­i­cians, researchers, schol­ars, and advo­cates from a vari­ety of dis­ci­pli­nary back­grounds with widely diverse views. In this report, we will describe many of the com­plex­i­ties, pay­ing close atten­tion to the inerad­i­ca­ble role that value com­mit­ments play not only in deci­sions about the appro­pri­ate modes of treat­ment, but also in diagnosis.

Troubled Children – Hastings Center Report on Pediatric Psychiatry 

Erik Parens and Josephine Johnston, “Troubled Children: Diagnosing, Treating, and Attending to Context,” Special Report, Hastings Center Report 41, no. 2 (2011). 

Acknowledgements 

We are deeply grateful to Alison Jost for her research assistance.

Workshop participants (institutional affiliations are in USA unless otherwise noted) were the authors, Erik Parens and Josephine Johnston, and:

Marcia Angell, Senior Lecturer in Social Medicine, Department of Social Medicine, Harvard Medical School;

Sidney Callahan, Distinguished Scholar, The Hastings Center;

William B. Carey, Clinical Professor of Pediatrics, University of Pennsylvania School of Medicine, Division of General Pediatrics, The Children's Hospital of Philadelphia;

Carol Caruso, Board of Directors, National Alliance on Mental Illness;

Peter Conrad, Harry Coplan Professor of Social Sciences, Department of Sociology, Brandeis University;

Elizabeth Jane Costello, Professor of Psychology, Duke University Medical Center;

Jörg Fegert, Professor and Chair of Child and Adolescent Psychiatry and Psychotherapy, University of Ulm, Medical Director of the Department of Child and Adolescent Psychiatry and Psychotherapy, Ulm University Hospital, Germany;

Michael B. First, New York Psychiatric Institute, Department of Psychiatry, Columbia University;

Sara Harkness, Professor of Human Development, Pediatrics & Anthropology, Director, Center for the Study of Culture, Health, and Human Development, University of Connecticut;

Steven E. Hyman, Provost, Harvard University, Professor of Neurobiology, Harvard Medical School;

Peter S. Jensen, Professor of Clinical Psychiatry, Columbia University, Research Psychiatrist, New York State Psychiatric Institute;

Kelly J. Kelleher, Professor of Pediatrics, Public Health, and Psychiatry, Colleges of Medicine and Public Health, and Department of Psychiatry, The Ohio State University, Vice President for Health Services Research, Director, Center for Innovation in Pediatric Practice, Columbus Children's Research Institute;

Julia Kim-Cohen, Assistant Professor, Department of Psychology, Yale University;

Roy P. Martin, Professor Emeritus, Department of Educational Psychology, University of Georgia;

Jon McClellan, Associate Professor, Department of Psychiatry, University of Washington;

John Z. Sadler, Daniel W. Foster Professor of Medical Ethics, Professor of Psychiatry & Clinical Sciences, Director, UT Southwestern Program in Ethics in Science and Medicine, Director, Center for Values in Medicine, Science, & Technology The University of Texas at Dallas, Co-Editor:Philosophy, Psychiatry, & Psychology, Department of Psychiatry, University of Texas Southwestern;

Kenneth F. Schaffner, University Professor of History and Philosophy of Science, Professor of Psychiatry, University of Pittsburgh;

Ilina Singh, Wellcome Trust University Lecturer in Bioethics and Society, London School of Economics and Political Science, United Kingdom;

Bonnie Steinbock, Professor, Department of Philosphy, University at Albany/SUNY;

Charles M. Super, Professor of Human Development and Family Studies, Co-Director, Center for the Study of Culture, Health, and Human Development, University of Connecticut;

Benedetto Vitiello, Chief, Child & Adolescent Treatment & Preventive Intervention Research Branch, National Institute of Mental Health;

Julie Magno Zito, Associate Professor of Pharmacy and Psychiatry, University of Maryland.

Funded by grant U13 MH78722 of the National Institute of Mental Health to the Hastings Center (Principal Investigator: Erik F. Parens, Ph.D.)

Conflicts of Interest in children's psychotropic clinical trials

via The Alliance for Human Research Protection:

Conflicts of Interest in Clinical Trials
Presented by Vera Hassner Sharav
14th Tri-Service Clinical Investigation Symposium
Sponsored by The U.S. Army Medical Department
and The Henry M. Jackson Foundation for the Advancement of Military Medicine
May 5-7, 2002

Case 7: Children exposed to risks in psychotropic drug trials:

Psychotropic drugs are being tested in children despite the acknowledged risks of harm. Psychotropic drugs are advertised as normalizing a "chemical imbalance" in the brain. In fact, they do the opposite: they induce profound changes in the central nervous system with demonstrable physical and neurological impairments.[48] Dr. Steven Hyman, former director of NIMH, an expert on the mechanisms by which psychoactive drugs work, explained that, whether abused or prescribed, the mechanisms by which psychoactive drugs work are the same.[49] Hyman stated that antidepressants, psychostimulants, and anti-psychotics created "perturbations in neurotransmitter function."[50] The drugs' severe adverse side effects are symptoms of the drugs' disruptive effect on the neurotransmitter system and on brain function.

In 2001 Dr. Benedetto Vitiello, NIMH's director of Child and Adolescent Treatment and Preventive Interventions Branch acknowledged the impact of FDAMA: "pediatric psychopharmacology has recently seen an unprecedented expansion clinical trials in youths has more than doubled in the last few years."[51] Indeed, children as young as three are being recruited to test mind-altering drugs that may affect their developing brain. Parents are being offered financial inducements to volunteer their children for drug trials. The foremost problem with prescribing or testing psychotropic drugs for children is the absence of any objective criteria for diagnosing children with pathological behavioral problems to justify pharmacologic intervention. Vitiello acknowledged "diagnostic uncertainty surrounding most manifestations of psychopathology in early childhood."[52] Vitiello also acknowledged the possibility of long-term harm: "The impact of psychotropics on the developing brain is largely unknown, and possible long-term effects of early exposure to these drugs have not been investigated."

Eli Lilly's highly touted new anti-psychotic, Zyprexa,[53] reveals much about the collision between corporate interests and the health and safety of children. In clinical trials averaging 6 weeks, Zyprexa was tested in 2,500 adults. The drug was linked to serious, in some cases life-threatening side effects requiring hospitalization in 22% of those tested.[24]Acute weight gain of 50 to 70 lbs is usual, and with it the increased risk of diabetes. FDA data (under FOIA) reveals a 65% drop out rate, and only 26% favorable response. During those 6 week clinical trials there were 20 deaths, of which 12 were suicides.[54] David Healy, who found a suicidal link to antidepressants (Selective Serotonin Re-uptake Inhibitors) in his research says, as far as he can establish, the data from these trials "demonstrate a higher death rate on Zyprexa than on any other antipsychotic ever recorded." [55] In 2000, FDA approved Zyprexa for short- term use only, in bi-polar patients. [56]

Yet, children aged six to eleven were recruited for clinical trials to test the drug. According to their published report, UCLA investigators tested Zyprexa on children who were not even diagnosed as having schizophrenia. The children were diagnosed as having a variety of questionable psychiatric disorders, including ADHD.[57] According to the published report, all the children in the trial experienced adverse effects, including sedation, acute weight gain, and akathisia (restless agitation). The trial was terminated less than six weeks after it had begun.

Controversy surrounds a Zyprexa trial at Yale University. In that experiment, 31 youngsters aged 12 to 25 who have not been diagnosed with any psychiatric illness are being exposed to the drug for one year. The stated rationale given by the researchers (who are under contract with the sponsor) is their speculation that these children may be "at risk" for schizophrenia. Since there are, as yet, no objective tests or biological markers for the illness - they hypothesize without evidence, merely on the basis of conjecture. The shaky basis for their conjecture is that assumption that the children may develop schizophrenia because one of their siblings has been diagnosed with the disorder.

The risk of schizophrenia for the general population is 1%. For siblings the risk increases from 2% to 15% - in other words there is 85% likelihood that these children will never develop schizophrenia.

Given the absence of scientifically accurate tools for interpreting psychiatric symptoms, psychiatrists cannot as yet accurately diagnose schizophrenia much less predict which children will get it. Is it ethical to expose healthy children to risks of drug- induced pathology on such speculation? The Wall Street Journal aptly noted that such a study "raises the question of whether the drug companies are mainly interested in "creating" a new illness that requires drug treatment." Read the entire report here

via Alliance for Human Research Protection:

State Medicaid agencies began to question "off label" use of antipsychotics after the December 2006 death of Rebecca Riley, a four-year-old Massachusetts girl whose family received Medicaid benefits. After being diagnosed with bipolar disorder at age two, she was prescribed a cocktail of drugs, including an antipsychotic, court records show.

Some states began moving to require special approval before they would cover a claim for an antipsychotic. A group of 16 states started studying the use of psychiatric medication in children in 2007 in an effort they dubbed "too many, too much, too young," says Jeffrey Thompson, the medical director of the Washington state Medicaid program.

In California, the number of children six and under using psychiatric medications has fallen to 4,200 from 5,686 since a 2006 prior-authorization plan was put in place, the state's top Medicaid official says.

Florida's state Medicaid agency says the number of prescriptions for atypical antipsychotics written for children under age six in the second half of last year dropped to 1,137 from 3,167 a year earlier.

The agency says the decline was the result of a state program started last year under which prescriptions for children under six are reviewed for appropriateness by state-hired psychiatric consultants before Medicaid will cover them.

Washington has created a system to flag the use of psychiatric drugs that may contain too high a dose for young children or have side effects that it regards as particularly dangerous. From May 2006 to April 2008, the system flagged 1,032 cases for review by outside consultants.

Write to David Armstrong at david.armstrong@wsj.com

Printed in The Wall Street Journal, page B1 Complete article here
Copyright 2009 Dow Jones & Company, Inc. All Rights Reserved

via National Association  of Medicaid Directors 2012 Fall Conference:

The Problem

• MH conditions account for large share of overall illness burden and expenditure -- directly and via impact on treatment and course of co-occurring medical conditions.  

• For publicly insured, responsibility for and data on MH tx often fragmented between multiple systems; care processes and outcomes often fall short. Prescription pad often easier to access than appropriate, coordinated, evidence-based services. 

• Appropriate, safe and effective use of antipsychotic (AP) and other psychotropic medications identified by states and other stakeholders as high-priority QI issue.  High rates of off-label AP use, often without adequate psychosocial mental health services, are a concern.  

• Use patterns vary widely; uptake of evidence based practices highly uneven.  Need for more effective monitoring and management of these powerful but not risk-free treatments.

• Recent developments such as GAO report on prescribing in foster care and IG report on prescribing in nursing homes reinforce the need.

• States need tools to address these needs.Key Concerns

• Within-class and between-class polypharmacy; dosage; use in children under 6:  “too many, too young, too much.”

• High psychotropic use and polypharmacy in foster youth.

• Use in nursing home (and community) elderly with dementia, despite significant safety concerns and FDA black box warning.  

• New national concerns sparked by GAO reports on psychotropics in foster youth, and IG report on antipsychotics in nursing home elderly.  New ACYF requirements for foster youth; CMS goal of reduction in AP use in nursing homes.

• Monitoring and managing metabolic risks of antipsychotics.

• Monitoring and improving adherence (adult quality measure on consistent use of AP meds in benes with schizophrenia is a good place to start).

• MH assessment and services consistent with treatment.

• Inconsistent access to some treatments (e.g., evidence-based psychosocial interventions, trauma-informed treatments, clozapine).

Informed Consent protocol for foster kids in Washington State protects the State. Let's be real, who in their right mind would believe that it is in the "best interests" of children and teenagers in the care and custody of Washington State to have no adult/advocate to give Informed Consent for medical care? Adolescents who want and need mental health and/or substance abuse treatment should get it, regardless of familial support or familial status; pretending that kids are physically/emotionally adult enough to legally give Informed Consent BUT ONLY for psychiatric diagnoses, including alcoholism and drug addiction is unethical to say the least...morally reprehensible really. Human brains are not fully mature until the early twenties. In reality, the State of Washington  "legally" placed foster kids in harm's way by relying on a profession with a history of dishonesty, abuse of authority and abuse of "Medical" privilege. As a society, we have in effect deprived of one of the safeguards which may protect them from iatrogenic injury, or worse...

TMAP is considered a "Best Practice"

Primum non nocere 

Declare the past, diagnose the present, foretell the future; practice these acts. 

As to diseases, make a habit of two things to help, or at least to do no harm. 

A doctor who thinks TMAP is a "Best Practice," isn't much of a doctor...

Jeffrey Thompson, M.D. Medical Director, Washington State Department of Social and Health Services, testifying in a HEARING before the SUBCOMMITTEE ON INCOME SECURITY AND FAMILY SUPPORT of the COMMITTEE ON WAYS AND MEANS U.S. HOUSE OF REPRESENTATIVES MAY 8, 2008 on PRESCRIPTION PSYCHOTROPIC DRUG USE AMONG CHILDREN IN FOSTER CARE

A few excerpts:

"We note that the data is presented in a non-judgmental manner. This brings the Committee together, and I might add, the drug companies are actually at the table when we discuss this. What we want to do is stop and take a short, deep breath and review the treatment plans to ensure that there's an integrated plan for the treatment. (emphasis mine)

 
"Recently, our safety standards for stimulants have steered as many as 56 percent of prescriptions for stimulants to lower dose, fewer medications, and sometimes to rethink prescriptions in the very young. Note that 44 percent of prescriptions that are at high dose are in the very young, when our community and us agree that this is actually the appropriate use. (emphasis mine)

"When we look across the country we see antipsychotic use that varies between states--as much as 4% to 13% in the Medicaid populations. Because there is so much variation, the Medicaid medical directors asked NASMD and AHRQ to sponsor an up-to-date pharmacy claims and program bench marking project. We hope this bench marking will highlight "best practices'' like the Texas algorithims..." (emphasis mine) here 

Those Texas algorithms, known as TMAP is a marketing strategy that is used to sell the newest most expensive psychotropic drugs; TMAP was never a "best practice" it was always simply a fraudulent marketing strategy with patently false claims that the  preferred drugs on what Jeffery Thompson called, "the Texas algorithms" were safer and more effective than the older ones; justifying their high cost. TMAP algorithms played a critical role in  the massive amount of Medicaid fraud.  Apparently, here in Washington State it still does.    

I am having difficulty wrapping my mind around the idea that 44% of psychotropic drugs being  prescribed in high doses are being given to the very young here in Washington State. This is, according to Jeffery Thompson's testimony, "the appropriate use" for the drugs. He's obviously working closely with (or is it for?) the drug companies.  So very unethical for Washington's Medicaid Director to have characterized TMAP as a "best practice;" Allen Jones had filed a Federal Whistle-blower Lawsuit in 2004, the State of Texas joined it in 2006. In 2008, when Jeffery Thompson called "the Texas algorithms" a "best practice," it was well known that TMAP was simply an unethical marketing scheme. 

This is the same Director who issued an "emergency warning" for Methadone AFTER 2,173 deaths had become public knowledge.

Washington State hired an architect of the TMAP fraud

The number of children taking neuroleptic drugs, called "antipsychotics," doubled from 2000-2010

"The scientific endeavor is based on vigilance, not trust." 
Jonathan King, Professor of Molecular Biology, M.I.T. Science and Engineering Ethics, 5:215-217.

The number of deaths from all prescription drugs more than quadrupled.

How many of the deaths were children prescribed psychiatric drugs off-label?

I wonder if experimental use of prescription drugs, called "off-label" prescriptions, would be so prevalent if the raw data from federally funded research, and the data used to gain a drug's FDA approval were available for public examination; instead of being hidden? People are dying at an alarming rate--including children from taking FDA approved prescription drugs as directed. How many of the deaths are a direct result of inappropriate, unsupported experimental use? Consensus based standards of care that recommend prescribing FDA approved neuroleptic, or other psychotropic drug "off-label" to children that are are without robust evidence to support using the drugs in this manner, are surely part of the problem. Have medical professionals allowed exaggerated claims of drug safety and efficacy and the minimizing of drug risks to cloud their professional judgement? Exaggerated claims of a drug's effectiveness coupled with a denial of or minimizing of the actual risks is unethical; publishing inaccuracies in professional journal articles has undermined the integrity of the evidence base, and the medical profession.  Worse, published inaccuracies put physicians and patients at a distinct disadvantage: misinformed doctors misinform and mistreat patients.

via Department of Health and Human Services Office of Rearch Integrity:

‎"in all these efforts the criteria for professional scientific integrity were similar; even if the individual was your best friend, you asked to see the data; and if the data was in summary form, you asked to see the raw data. It was common to challenge a colleague's claim that he had carried out some procedure very carefully or precisely." Jonathan King, Professor of Molecular Biology, M.I.T. Science and Engineering Ethics 5:215, 1999.

"Though the subjective and social components of science are real and often critical, the striving to determine the truths about nature independently of these variables is one of the most enduring values of science. This is not based on trust, but on evidence, rigor, and honesty. The honesty is established by not calling upon trust, but demonstrating that one did what one said one did." Jonathan King, Professor of Molecular Biology, M.I.T. Science and Engineering Ethics 5:216, 1999. here

Direct to consumer marketing of FDA approved drugs does not comply with truth in advertising and consumer protection laws; the drugs are killing hundreds of thousands of Americans. But FDA enforcement resources are focused on advertisements for vitamins, nutritional supplements, and organic foods that are not killing people. Failure of the FDA to be accountable for the drugs the FDA approves is a failure to protect the American people who are dying at an alarming rate from "safe and effective" FDA approved drugs.

via The FDA:

AERS Patient Outcomes by Year 2000-2010

2000     19,445    153,818

2010     82,724    471,291

                    Deaths    Adverse Event

via RT.com

Pharmageddon: America’s bitter pill

The United States has a passion for pills, being the world's biggest users of psychotropic drugs, consuming 60 per cent of them. And pharmaceutical firms are keen to keep cashing in on the multibillion-dollar market, even if it costs people's health.

America is regarded as a country with a prodigious appetite for consumption. Today, a widespread fondness for pharmaceuticals has turned the US into a nation of pill-poppers.

With over $14 billion in annual sales, antipsychotics remain the top-selling therapeutic class of prescription drugs in the US.

Dr. Harriet Fraad believes Big Pharma has manufactured a climate of insanity by manipulating and even creating illness for capital gain.

“One of the things that drives Big Pharma is to find a diagnosis that is very vague, so that everybody can fall into that,” she told RT. “Everybody is sad sometimes. There are good reasons. The point is to market pharmaceuticals. And the advertising strategy is to have vague diagnosis and then find wiggle room so that they apply to everyone.” read here.

ASK YOUR DOCTOR
 if dry mouth, insomnia, sexual dysfunction, diarrhea,
nausea and sleepiness might be right for you!

"I'm looking for an end to giving kids who are sad or distressed, drugs that double their risk 

of suicide. I'm looking for the appalling rate of child suicide in my country to be reduced. I 

want my son, my only child, to have a legacy and I need to feel I'm still his mother and 

promoting his best interests and this is the only way I know how to parent a dead child."

Maria Bradshaw, the mother of Toran Henry and co-founder of Casper

Casper Suicide Prevention Strategy

vintage ad found here.


bs meter and rfk pic found here.
first posted Dec 29, 2011