Psychiatric Drug Facts via breggin.com :

“Most psychiatric drugs can cause withdrawal reactions, sometimes including life-threatening emotional and physical withdrawal problems… Withdrawal from psychiatric drugs should be done carefully under experienced clinical supervision.” Dr. Peter Breggin
Showing posts with label Psychiatry. Show all posts
Showing posts with label Psychiatry. Show all posts

Aug 27, 2013

I say it's quackery...


Medical standards of care originally were based on clinical research and clinical experience; ethical medical standards originally were diagnostic procedures and treatments for symptoms and medical illnesses with known risks and potential benefits discussed for informed consent for prescribed treatment. Standards of care protected patients from unsafe medical practices and unethical professionals. The standards being promulgated for use in standard psychiatric clinical practice and recommended for use in pediatric and general medical clinics currently are written to conform to what is, and has been standard practice in real world mental health clinical practice for decades.

In real world clinical practice, it not unusual for irresponsible off label prescribing of dangerous psychotropic drugs with little, if any empirical support; i.e. drugs are prescribed for no valid, ethical medical purpose. Incredibly, drugs are prescribed without empirical evidence of either the drug's safety or effectiveness for the patient, and/or the condition and/or syptom the drug is prescribed to treat, drugs are sometimes the only "treatment" available. Psychiatry's current standards of care protect psychiatrists and the other medical practitioners who are trained to practice "psychopharmacology," not evidence based medicine, social and political control of individuals based on consensus of professional opinions.  Psychiatric "standard treatment" endangers patients. Obviously, psychotropic drugs which have teratogenic effects and have inherent risks which include cognitive, neurological and physical disabilities and early/sudden death. Once drug impaired, psychiatric patients are limited in their capacity to complain of mistreatment and effectively advocate for themselves. Many will develop drug-induced cognitive, neurological, metabolic, and cardio-vascular impairments which are medically neglected by the doctors who inflict them.

Apparently, it's an article of faith for psychopharmacologically inclined psychiatrists to believe the subjective observations and opinions of psychiatrists can miraculously transubsantially transform agreed upon opinions and beliefs into "scientific evidence" through a quasi-democratic process of consensus. Imagine that! A consensus of the opinions of psychiatrists validates psychiatric diagnostic criteria. Psychiatrists agree teratogenic drugs are therapeutic and "necessary" by legal force if required. Seemingly, by ignoring the direct adverse effects of teratogens on their patients,  psychiatrists become willfully blinded to disabilities and infirmaties, the iatrogenic medical injuries that consensus based psychiatry inflicts upon humanity with seeming impunity.

In every other field of scientific inquiry, subjective observation and opinion is suitable only to support findings and conclusions derived from empirical data collected in research and real world practice. Educated subjective opinions and observations are no substitute for medical knowledge gained from ethical scientific research, and thoughtful consideration of all available data. Using medical terms,  relying on consensus without offering valid empirical evidence to support psychiatric standards of care is an egregious abuse of power, authority and medical  privilege---There is no substitute for empirical evidence, and no excuse for abdicating the use of sound medical judgement and ethical medical principles.

Psychiatry's consensus-based diagnostic manual, the DSM, and consensus-based treatment algorithms such as TMAP and , are not ethically, medically or scientifically valid. TMAP and T-MAY, are consensus-based treatment protocols developed to market drugs and/or unethically "validate" off label prescription of dangerous FDA approved drugs; i.e. off label prescribing becomes psychiatry's "standard of care"absent empirical support or contrary to available evidence of either  drug safety or effectiveness for patient or symptom or condition...

How did off label use of dangerous drugs become so common, more importantly, how can it be considered ethical or even a "standard medical practice?" Psychotropic drugs are teratogens; yet they are prescribed without evidence of effectiveness, even though they have inherent, disabling, even fatal risks.

Abuse of prescription privileges. 
Psychiatry: a consensus-based standard of care. 

Psychiatry's so-called standards of care are commonly used to "validate" the prolific off label prescribing of neuroleptic, or so-called "antipsychotic" and other psychotropic drugs to children, the elderly and traumatized veterans. Treatment algorithms are based on consensus and "validated" by a quasi-democratic process. In reality, what are obviously political decisions are the justification, not exactly the needed evidence base, for so called standards of care. These "standards" which primarily serve to protect practritioners who use them by providing a pre-emptive affirmative defense against medical malpractice for iatrogenic injuries. Standards of care shield psychiatrists against malpractice claims for drug-induced iatrogenic injuries, permanent disabilities weven  fatalities inflicted with impunity. Most victims are mostly poor and/or reliant on Federal Medical programs. Marginalized by poverty, stigmatized with a diagnostic label, patients can be systematically dis-empowered a direct effect of legislating bigotry. Grass roots advocates who proclaim themselves to be "The Nation's Voice on Mental Illness" do not acknowledge psychiatric survivors/victims, much less advocate justice for victims of iatrogenic harm, educate the public about drug-induced disease, disability and death. The Nation's Voice does not speak for those who are killed as a direct result of psychiatric treatment.

via 1 Boring Old Man:
a mess, [still] deserving close attention…
a couple of excerpts:
"Childhood Psychosis is an uncommon finding, but can be associated with significant impairment, and the article mentioned by Dr. Purssey purports to be discussing childhood psychosis. But we all know that the extensive use of Atypical Antipsychotics in children [Medicaid children] isn’t about childhood psychosis at all. It’s off-label uses. The drugs are being prescribed for behavior control. That’s where the costs come from. That’s where the dangers are. That’s where the risk/benefit equation has been massively perverted. That’s the reason for the alarm. These are the kids that were inappropriately labeled Bipolar, justifying the use of these medications.

"There can be little question that the incidence of behavioral problems among the children on Medicaid is quite high. In fact, it would be surprising if that weren’t the case. Many of them are foster children or otherwise born into families in difficult circumstances. And for all its glitches, our foster-care system beats the orphanages of a former time hands down. These medications can be somewhat effective in situations when these children inevitably present with behavior problems, but at a very high price. Foremost, this is not a situation best approached by symptom control. Childhood is not something to be gotten through. It’s the period of complex development that shapes directions for a lifetime. This is a self-evident truth. It’s impossible to imagine that the important work of childhood can proceed through the fog of Antipsychotics – so the side effects such as the metabolic syndromes are an additional burden to children already swimming up-stream. Rampant medication in these situations is a clearly inappropriate and dangerous medical solution to a psycho-social problem. This is not simply something to decry. It needs to be stopped." read here

Here is the latest treatment algorithm to ensure kids will be drugged: 

via The Reach Instittute

T-MAY: Treatment of Maladaptive Aggression in Youth

Psychotropic agents are increasingly prescribed to aggressive youth on an outpatient basis,57 despite limited efficacy and safety data.6 For example, sixfold increases in outpatient antipsychotic prescriptions were found between 1993 and 2002,8 followed by further increases between 2002 and 2006,9 largely with aggressive, nonpsychotic youth. These practices fall largely outside of indications approved by the Food and Drug Administration, raising concerns about efficacy, safety, role of alternative therapies, polypharmacy, and appropriate parent engagement and education.9Furthermore, a significant portion of antipsychotic prescribing takes place by primary care physicians, including pediatricians. For example, an estimated 32.2% of antipsychotic prescriptions for children ages 2 to 18 during 1995–2002 were by non–mental health providers.10 Evidence-based guidance is necessary for implementing care that addresses patients’ severity and source of symptoms, development, primary diagnosis, coexisting conditions, and family situations.11
To address these needs, the Rutgers Center for Education and Research on Mental Health Therapeutics, in collaboration with Columbia University, the REACH Institute, and others, launched a consensus development initiative to address the outpatient management of maladaptive, impulsive aggression in children and adolescents.

Treatment of Maladaptive Aggression in Youth: CERT Guidelines II. Treatments and Ongoing Management

updated 2-17-2014

Aug 11, 2013

The Foucault Tribunal on the State of Psychiatry

Foucault5.jpg


the Foucault Tribunal took place on 
April 30 to May 3, 1998
at the "Volksbühne" in Berlin, Germany

The Verdict of the Foucault Tribunal
We conclude that, being unwilling to renounce the use of force, violence and coercion, psychiatry is guilty of crimes against humanity: the deliberate destruction of dignity, liberty and life. Most of all through the legal category of "mental patient" which permits a total deprivation of human and civil rights and the laws of natural justice. 

Furthermore, psychiatry cannot pretend to the art of healing, having violated the Hippocratic Oath through a conscious use of harmful drugs, which caused in particular the world wide epidemic of tardive dyskinesia, as well as other interventions which we recognize as tortures: involuntary confinement, forced drugging, four point restraints, electroshock, all forms of psychosurgery and outpatient commitment. 


These practices and ideology allowed the psychiatrists during the Nazi era to go to the extreme of systematic mass murder of inmates under the pretext of "treatment". 


Psychiatry not only refuses to renounce the force it has historically obtained from the state, it even takes on the role of a highly paid and respected agent of social control and international police force over behavior and the repression of political and social dissent. 


We find psychiatry guilty of the combination of force and unaccountability, a classic definition of totalitarian systems. We demand the abolition of the "mental patients" laws as a first step toward making psychiatry accountable to society. To this end, compensation will have to be made for the harms it has done. Public funds must also be made available for humane and dignified alternatives to Psychiatry.



Reasons for the Verdict
The defense speaks of the therapeutic necessity for psychiatric coercion and, if necessary, the use of physical
force. They admit though, that in "good psychiatric institutions" as little coercion as possible is used. Coercion is apparently not therapeutic, rather it is dependent on the type of psychiatry practiced. We condemn all forms of psychiatric coercion as a violation of human rights.


The laws for the mentally ill prescribe psychiatric coercion in the case of danger to oneself or others. In practice this is widely transgressed. The matter is only one of endangerment; no crime has been committed. This means that preventive detention is being practiced.


The defense describes someone as being mentally ill because his ability to help himself is reduced. They believe that he should be relieved of certain societal demands because of impairments in his ability to experience and behave as expected by society.


We are of the opinion that the accepted idea of illness is inadequate. In this case an institution such as a psychiatric hospital cannot offer any assistance.


We are of the opinion that treatment by doctors should only be applied on a voluntary basis.
It is especially dangerous that many judges are biased and that they agree with the expert opinions of the psychiatrists.


Psychiatric survivors have a right to demand financial compensation for any pain and suffering they experienced.

Berlin, 2nd of May 1998

Aug 6, 2013

My informed consent wasn't necessary


When I wrote about Jeffrey Lieberman in Caught Being Offensive...I focused on Lieberman's ridiculous assertion that critics of the DSM and the American Psychiatric Association are "prejudiced against psychiatrists, and psychiatry." Lieberman implied that any criticisms specific to psychiatric treatments used at an ephemeral point in the past; a point in time that is never clarified by Lieberman. Perhaps it is because Lieberman characterized mental health professionals and psychiatric survivors who are critical of the DSM and the American Psychiatric Association as being "anti-psychiatry" in a Scientific American blog post titled, DSM-5: Caught between Mental Illness Stigma and Anti-Psychiatry Prejudice

Unlike Dr. Judy Stone's articulate response to Lieberman's strange diatribe castigating critics of psychiatry, my response is that of a betrayed parent who now takes care of a 25 year-old son who was iatrogenically disabled as an adolescent in a research facility by neuroleptic drugs prescribed off label without Informed Consent by a federally funded psychiatric researcher, Jon McClellan. McClellan, acting as an agent of Washington State, repeatedly told me my informed consent wasn't necessary. He claimed I had no say in my son's psychiatric treatment. This unethical psychiatric researcher actually claimed telling me anything about how he was "medically treating" my son by repeatedly traumatizing and torturing him was only done as a "courtesy" to me.

My vehement protests were used to malign me as a parent. The psychiatrist who disabled my son recorded in my son's medical record that I am an "unreliable" source of information about his psychiatric history, symptoms and problems. Every other professional up to that point had noted that I have a great deal of insight and understanding of my son's issues. My complaints of unethical and illegal behavior include an estimated $1 million being defrauded from the federal child welfare and Medicaid programs, and Civil Rights violations intentionally perpetrated by agents of the state acting Under Color of Law using perjured testimony and fraud for "evidence." 

Human Experimentation without fully informed consent is a violation of the Nuremberg Code. Grievous harm was inflicted upon my son by unethical mental health and child welfare "professionals" acting Under Color of Law.  These public servants violated both my son's and my Civil Rights repeatedly with impunity, they broke State, Federal, and International Laws as agents of the state. None of these crimes have been investigated by Law Enforcement...

My son was repeatedly traumatized; in reality, tortured, abused and used as a human guinea pig by a federally-funded research psychiatrist and co-investigator in the TEOSS drug trials, namely, Jon McClellan who is the Medical Director of Child Study and Treatment Center in Lakewood, Washington and a professor of psychiatry at the University of Washington.  

For over twenty years, employees of the State of Washington and it's contracted providers have consistently abdicated their legally mandated responsibilities and have failed to ethically perform duties owed to my son, Isaac. The initial failures when my son was a pre-schooler, were criminally negligent. Instead of acting in defense of my 3-year-old son when he was victimized by a Washington State licensed foster parent, public employees who were mandated reporters working in Washington State's federally-funded child welfare program violated the ethical guidelines of their chosen profession and violated State law to cover up the felony assault of my 3 year old son by a foster parent who is suspected of killing four infants. 

I have good damned reason to be angry---I have been proceeded against in child welfare custody hearings by public employees who proffered perjured testimony and fraud as 'evidence;' to  'legally' strip me of my parental rights and prevent me from acting on my son's behalf.  I bore witness to my son being repeatedly assaulted, traumatically abused, medically neglected and ultimately disabled by mental health "professionals" who were aided and abetted by child welfare workers who violated federal law and claimed that it was necessary that my son to be made a ward of the state for his medical treatment to be reimbursed by the Federal Medicaid program---I later discovered since my son was already on Medicaid and his eligibility was never at risk, it was against Federal Law to require me to give up custody.

I believe this lie was offered in order to coerce my cooperation to sign an "Agreed Order to Place" to make my son a ward of the state, which would enable Washington State to commit fraud by illegally claiming child welfare funds for my son from the Federal Child Welfare program. 

I was misled by the state's publicly funded mental health program employees as well who falsely claimed Child Study and Treatment Center, CSTC, is a hospital; it is licensed as a psychiatric research facility for children and adolescents---it is not a hospital. Once at CSTC, the medical director, research psychiatrist, Jon McClellan, violated the ethical guidelines for Informed Consent of the medical profession while breaking multiple State, Federal and International laws governing the treatment of human beings, and the protection of children who are wards of the State of Washington.  

In the last three years, 3 different psychiatrists have lied to us; the last two actually had the audacity to immediately demand my "respect" after denying the drugs prescribed to my son do in fact cause brain damage. The third psychiatrist told me 3 times that the drugs do not cause brain damage, he then demanded my respect...

tear down the silos and reunify psychiatry and neurology!



zazzle.co.uk

The first step in the evolution of ethics is a sense of solidarity with other human beings.
Albert Schweitzer 


Henry Nasrallah, MD, editor-in chief of Current Psychiatry ONLINE, claims that there have been "developments" that "are bringing neurology and psychiatry together again" in his latest editorial. 
The first development Nasrallah shares predictably is "The neuropharmacological revolution in psychiatry;" he neglects to mention the "revolution" relied upon deceit, i.e. misleading patients, the public, and other medical professionals about the symptoms and the etiology of symptoms; the subjective nature of a psychiatric diagnosis; the effectiveness of the available treatments; the dangerous risks endemic to using teratogenic, psychotropic drugs and/or electric shock machines that have never been safety tested...
via Current Psychiatry online:
Vol. 12, No. 08 / August 2013      
                                         
Featured alongside Dr. Nasrallah's editorial was this advertisement:
Click here to find out more!
Henry A. Nasrallah, MD
Editor-in-Chief

Let’s tear down the silos and reunify psychiatry and neurology!
Psychiatry is as much anchored in the brain as its sister specialty neurology is

  • The neuropharmacological revolution in psychiatry and the discovery of medications that control the symptoms of psychosis and of mood and anxiety disorders
  • The explosive growth of neuroscience, which was catalyzed and enhanced by sophisticated investigational techniques
  • The computerization revolution, which has facilitated development of myriad neuroimaging techniques that reveal, in vivo, the multiple neurological and neuropathological abnormalities associated with psychiatric disorders
  • Breakthrough advances in molecular and cellular neurobiology, which are linking behavior, thought, affect, and cognition with specific signaling pathways. This has led to the scientific epiphany that psychiatric brain disorders cannot be localized (as neurologic brain disorders are) because they are caused by disrupted neural circuits and connectivity and are not localized in cortical or subcortical regions
  • The molecular genetics revolution, which has revealed the complex genetics of psychiatric disorders, including risk genes, copy number variants, nonsense mutations, and epigenetics. With 50% of the 22,000 genes in the 23 pairs of human chromosomes involved in brain development, it isn’t surprising that the neurogenetics of mental illness are mainly aberrations in neurodevelopment genes—just as most non-genetic factors disrupt normal brain development during fetal life.
  • The recognition, over the past 2 decades, that anomalies of neurochemistry and neuroplasticity are the underpinnings of psychiatric illness.

read the editorial here


Aug 5, 2013

Is the use of coercion and force in psychiatry ethical?


via The New York Times:
LETTER

Forced Drug Treatment

an excerpt:
"In a society presumably under the rule of law, is it proper for physicians and other mental health professionals to coerce innocent individuals and force them to ingest dangerous drugs?"

DAVID COHEN
TOMI GOMORY
STUART A. KIRK
Los Angeles, July 31, 2013
read the letter here
The writers are professors of social welfare and co-authors of “Mad Science: Psychiatric Coercion, Diagnosis and Drugs.”
hat tip:
Whenever a doctor cannot do good, he must be kept from doing harm.  Hippocrates 

via American Journal of Psychiatry:
The Cost of Assisted Outpatient Treatment:
Can It Save States Money?

Jun 14, 2013

Washington State Constitutional Rights of Psychiatric Patients Violated Under Color of Law

RCW  71.05.520  – Protection of rights.


“The department of social and health services shall have the responsibility to determine whether all rights of individuals recognized and guaranteed by the provisions of this chapter and the Constitutions of the state of Washington and the United States are in fact protected and effectively secured.
To this end, the department shall assign appropriate staff who shall from time to time as may be necessary have authority to examine records, inspect facilities, attend proceedings, and do whatever is necessary to monitor, evaluate, and assure adherence to such rights. Such persons shall also recommend such additional safeguards or procedures as may be appropriate to secure individual rights set forth in this chapter and as guaranteed by the state and federal Constitutions.”
[1973 1st ex.s. c 142 § 57.]

The State of Washington Department of Social and Health Services does not in fact have any appropriately trained investigators assigned to examine records or investigate complaints that criminal violations of any individual's rights, "recognized and guaranteed by the provisions of this chapter and the Constitutions of the state of Washington and the United States are in fact protected and effectively secured." There is no plan to change this.  David Reed works as an administrator for Washington State's the Department of Social and Health Services, Division of Behavioral Health and Recovery, and oversees the Involuntary Treatment program for DSHS. Mr. Reed is the individual who was appointed to investigate complaints of civil rights violations in Involuntary Commitment proceedings in 2008, by then-Governor, Christine Gregoire.  When I called Mr. Reed on the morning of July 8, 2011 to ask if he was aware of any complaints being filed that an individual's rights had been violated in  civil commitment proceedings, I already knew the answer to the question I was asking.  I was asking the question to see whether Mr. Reed would give a truthful answer. Mr. Reed has a poor memory, or he purposely lied to me in giving an answer. If one were to assume that Mr. Reed's memory failed one could further assume he forgot sending the following letters to the advocacy group, Crossroads for Change Campaign, and that he forgot being appointed by the governor to investigate the complaints of civil rights violations...

In a letter dated September 10, 2008, Mr. Reed responded to complaints that multiple individuals civil rights were violated; stating in part, “The documentation you have presented to the Mental Health Division is more than five years old and concerns a single RSN.  The practices you have identified were subsequently rectified and represented a small portion of the detentions in the state.  I have sent you a copy of DMHP Protocols in Appendix I § 6 is a list of Washington State Case Law.  By utilizing the website:  www.legalwa.org  you can review the listed legal decision of Washington State Courts that have previously affirmed the constitutionality of RCW 71.05’s due process provisions.  Other concerns you have addressed are addressed by statute and are monitored by MHD licensure staff.”  here

The law as written was affirmed to be Constitutional, only because the due process provisions the State of Washington and the U.S. constitutions require to be preserved and defended in civil commitment proceedings, are defined within the text of the Involuntary Commitment Statute. Obviously, if the law is not followed by the designated mental health professionals given the authority to implement the law, who detain individuals Under Color of Law, and the mental health professionals who subsequently petition the Court to civilly commit individuals Under Color of Law, an individual's rights will be violated.

In a letter dated January 7, 2009 Mr. Reed writes, "I have discussed your concerns with Mental Health Division management.  After review of the additional information you provided at our last meeting regarding an involuntary hospitalization from 2005, the Mental Health Division is unable to endorse your request for action and investigation.  The concerns you have presented are of concern and will be forwarded to our Licensure staff which is tasked with correcting WAC and RCW violations for detained consumers on the part of RSNs, Evaluation and Treatment Facilities and DMHPs.   I look forward to meeting with you again to continue our discussion the ITA process as it is currently implemented in Washington.” here

SPOKANE QUALITY REVIEW TEAM Investigation and Survey Results Regarding the Legal Representation by The Spokane Public Defender's Office for the Involuntary Treatment Act process

My son, who is now 25 years old, has been victimized by unethical mental health professionals who commenced illegal civil commitment proceedings against him twice as an adult in Washington State. Neither time were his civil rights preserved or defended.  

In 2010, my son was detained based entirely on perjured testimony and a fraudulent affidavit forged by Nancy Sherman, the Designated Mental Health Professional.  The same false tainted "evidence" was used by Jeffrey Jennings; a psychiatrist who relied upon Sherman's falsehoods because he had no "first-hand" information to offer in support of his petition for a Court Order for Involuntary Treatment since Jennings refused to speak to anyone who actually had first-hand information. 

The third hearing at which a Superior Court judge granted a six month out patient involuntary treatment order, lasted all of one minute and 26 seconds--my son was not at this or the two prior hearings; indeed, my son was not even aware that any legal proceedings had taken place. My son wasn't aware that the woman who had him sign papers and who informed the court he understood and waived his Constitutional right  to a jury trial, and that he agreed to follow Jeffrey Jennings' prescribed treatment recommendations was an attorney; much less, that the woman was his own Court Appointed attorney...  

The felony crimes of fraud and perjury were committed by mental health professionals in Yakima County Superior Court; a fraudulent affidavit and perjury were proffered as "evidence" used to detain and involuntarily treat my son. There was no criminal investigation of the crimes reported on my son's behalf, nor was there an investigation of the illegal shredding of Court records that was also reported. The CEO of Central Washington Comprehensive Mental Health, a current NAMI Washington Board member, Rick Weaver, claimed there is nothing wrong with shredding original Yakima County Superior Court records for Involuntary Commitment hearings, telling me,  "we do it all the time."  How is it that the illegal shredding of original Superior Court documents used to detain and Court Order people targeted for Involuntary Treatment allegedly because they are incapable of making treatment decisions, is not referred to Law Enforcement for criminal investigation?

the second time my son was committed in 2011, the attorney appointed by the court to represent my son had an obvious conflict of interest., the attorney also did legal work for the psychiatric facility that sought the Benton County Superior Court's order to treat him involuntarily! The attorney's obvious conflict of interest was never disclosed to my son, or to any of the three people who are designated representatives authorized to protect his interests when he is unable to do so himself. All three of us were present and conferred with the attorney and the psychiatrist.  I discovered that my son's attorney also does legal work for the facility when I conducted an internet search seeking the attorney's contact information. The attorney had failed to provide any of his contact information to my son. no phone number, no e-mail address; no way to contact him at all... 

Jun 4, 2013

How mental health law discriminates against people with mental illness

Professor George Szmukler, Institute of Psychiatry, King’s College London
How mental health law discriminates against people with mental illness 
 Summary
Mental health legislation, as currently conceived in most jurisdictions, discriminates against people with a mental illness.  It carries underlying assumptions that people with such illnesses are not fully autonomous and that they are dangerous to others.  Thus such legislation reinforces damaging stereotypes of people with a mental illness.  By building on the complementary strengths of capacity-based and civil commitment legislation, we propose a ‘fusion’ of legal principles into a model law which has decision-making capacity at its centre, but which clearly defines how the use of detention and force are to be governed.  This comprehensive law is designed to apply to all persons who lack capacity, from whatever cause and in whatever healthcare setting.  We have drafted a model law that demonstrates these principles can be given practical expression11.  The model law, unlike the current MHA is, I would argue, compliant with the UN Convention on the Rights of Persons with Disabilities.

more here



Gresham College on youtube

photo from Gresham College on facebook 

Jun 2, 2013

Expert Consensus Guidelines: a thinly disguised prescription drug marketing strategy

Allen Frances, M.D.
via Wired Inside the Battle to Define Mental Illness
Photo: Susanna Howe; photographed at Café Sabarsky, Neue Galerie, NYC
A consensus of educated opinions is evidence only of agreement...it is not empirical evidence of diagnostic validity, a specific drug's effectiveness or safety for a specific condition or age group.  Treatment standards used in standard clinical psychiatric practice recommend drugs with serious  disabling and even fatal risks; yet the renown "Expert Consensus Guidelines" that recommend using the drugs, are based on the answers given by 41 psychiatrists on a survey developed with the intent that the survey answers would become the pseudo-evidence base for "Expert Consensus Guidelines," a critical component of an unethical plan to sell the idea that undesirable emotions and behaviors are "symptoms" of psychiatric disease. Symptoms are used to give a person a subjective psychiatric diagnosis;  often told they have a "disease," or "disorder" that  can then be altered with psycho-pharmaceuticals...er, I mean "safely and effectively treated." 

The fact is, except for the myriad of iatrogenic, or "physician caused," diseases. Iatrogenic diseases which are caused by the direct, adverse teratogenic effects of the prescribed drug/s mechanism/s of action. Neuroleptic, and other psychotropic drugs used by psychiatrists, can induce neurological, cognitive, and visual impairments, and cause metabolic, hormonal, cardio-vascular, and thermo-regulatory dysfunction; these adverse effects can become permanent disabilities. Iatrogenic duseases are often medically neglected by the "doctors" who cause them. Iatrogenic homicide is not uncommon; people are "successfully treated" when/if they are treatment compliant; even if the "treatment" is disabling and/or fatal...The "experts" don't count the number disabled and killed by psychotropic, or any other FDA approved drug; which effectively prevents an evidence based risk benefit analysis impossible.

Expert Consensus Guidelines
a critical part of a "successful," albeit unethical, prescription drug marketing agenda.

Expert Consensus Guidelines 
41 out of 46 expert psychiatrists agree: 
a consensus of "professional opinions" is empirical evidence!
   

OR...

41 out of 46 PigPharma Expert Psychiatrists agree: 
Human guinea pig$ are ca$h cow$

picture via FearLoathingBTX
It is plain that psychiatric standards of care based on the subjective opinions of "experts" on a survey are not valid "evidence;" much less, an ethical, scientific foundation for psychiatric treatment guidelines. Expert Consensus Guidelines are a drug marketing tool that harms patients and discredits medicine and psychiatry.

Originally, standards of care served to protect patients from unethical doctors using dangerous, ineffective, and/or unproven, treatments. In psychiatry, it appears the definition of treatment has been altered, and the purpose of treatment algorithms used in standard clinical practice serve primarily to protect the professionals from valid legal claims for iatrogenic harm. For example, "Expert Consensus Guidelines," the brain child of Dr. Allen Frances, Chairman of the Dept. of Psychiatry, Duke University; Dr. John P. Docherty, Professor and Vice Chairman of Psychiatry, Cornell University; and David A Kahn, Associate Clinical Professor of Psychiatry, Columbia University, founders of Expert Knowledge Systems, the educational division of Comprehensive NeuroScience, Inc. redefined the term, 'guideline' in order to disguise the fact that this guideline was part of a drug marketing agenda, as such, it was not based on any empirical evidence. It was developed and marketed as an evidence-based guide to prescribe psychoactive drugs in standard clinical practice marketed to general practitioners, pediatricians, and other medical specialists and like the infamous Texas Medication Algorithm Project, or TMAP, Expert Consensus Guidelines was initially funded by Johnson and Johnson, makers of Risperdal, as part of a marketing strategy.  

Seemingly overnight, neuroleptic, so-called, "antipsychotic" drugs, and other psychotropic drugs were being prescribed according to what may appear to be "legitimate" medical guidelines. Used by unwitting GPs, pediatricians, and other doctors to treat their patients emotional/behavioral difficulties believing the "expert" guidelines to be evidenced based, ethical standard of care; not a marketing strategy. Once critically analyzed, it's apparent that "Expert Consensus Guidelines" are not based on the treatment needs of psychiatric patients; or the safety and/or effectiveness of the drugs for the reasons prescribed. The guidelines are a commercial marketing scheme bought and paid for by a corrupt industry to sell the idea that emotional distress and undesirable behaviors are symptoms of neuro-cognitive biological diseases that are easily diagnosed, and effectively treated with Risperdal alone or in combination with other psychotropic drugs...

via PubMed:
Am J Manag Care. 1998 Jul;4(7):1023-9.

A new method of developing expert consensus practice guidelines.

Frances A, Kahn D, Carpenter D, Frances C, Docherty J.

Source

Duke University Medical Center, Durham, NC 27710, USA.

Abstract

To improve the quality of medical care while reducing costs, it is necessary to standardize best practice habits at the most crucial clinical decision points. Because many pertinent questions encountered in everyday practice are not well answered by the available research, expert consensus is a valuable bridge between clinical research and clinical practice. Previous methods of developing expert consensus have been limited by their relative lack of quantification, specificity, representativeness, and implementation. This article describes a new method of developing, documenting, and disseminating expert consensus guidelines that meets these concerns. This method has already been applied to four disorders in psychiatry and could be equally useful for other medical conditions. Leading clinical researchers studying a given disorder complete a survey soliciting their opinions on its most important disease management questions that are not covered well by definitive research. The survey response rates among the experts for the four different psychiatric disorders have each exceeded 85%. The views of the clinical researchers are validated by surveying separately a large group of practicing clinicians to ensure that the guideline recommendations are widely generalizable. All of the suggestions made in the guideline are derived from, and referenced to, the experts' survey responses using criteria that were established a priori for defining first-, second-, and third-line choices. Analysis of survey results suggests that this method of quantifying expert responses achieves a high level of reliability and reproducibility. This survey method is probably the best available means for standardizing practice for decisions points not well covered by research. (emphasis mine)

via Alliance for Human Research Protection:

"Not only were Frances, Docherty, and Kahn ready to violate standards of conflicts of interest in mixing guideline preparation with marketing for J&J, but also in publicizing the guidelines in coordination with J&J. The three men established Expert Knowledge Systems [EKS]. The purpose of this organization was to use J&J money to market the guidelines and bring financial benefits to Frances, Docherty, and Kahn."here

via The American Journal of Managed Care:






updated 9-15-2013
2-17-2014

May 24, 2013

Redefining mental illness


"[The DSM] it's not really a bible, it shouldn't be worshipped.  It's a guide, it's mostly a guide to clinical care to help in deciding who has what disorder, and what's the best treatment for it. Unfortunately [it] has been taken out of context, and used in many real life decisions often beyond the competence of the manual … so it's moved out of the clinical arena ... and now it has all sort of society influences often beyond its competence." Allen Francis, M.D.

via ALJAZEERA Inside Story Americas:

Redefining mental illness

As the new edition of an influential US psychiatry manual is released, we analyse its impact beyond clinical diagnosis.

 Last Modified: 23 May 2013 09:37
Inside Story Americas, with presenter Shihab Rattansi, discusses with guests: Dr. Allen Frances, former chair of the psychiatry department at Duke University and author of the book Saving Normal; and Robert Whitaker, a journalist and author of the book Anatomy of an Epidemic.  Read the article here 


hat tip: Kermit Cole at madinamerica.com

Apr 27, 2013

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

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