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

Trust me I'm a Ducktor

Updated on 12-5-2012

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

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

beginning of original blog post

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

via UC San Diego Health System:

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

some excerpts:

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

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

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

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

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

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

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

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

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

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

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

10.4088/JCP.09m05414yel

Copyright 2010 Physicians Postgraduate Press, Inc.

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

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

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

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

4/11/2005

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

 via Physician's Post Graduate Press:

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

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

J Clin Psychiatry

10.4088/JCP.12m08001

Copyright 2012 Physicians Postgraduate Press, Inc.

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

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

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

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

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

via ClinicalTrials.gov:

Side Effects of Newer Antipsychotics in Older Adults

Purpose

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

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


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

Detailed Description:

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

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

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

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

Exclusion Criteria:
N/A here

photo credit Just Ducks

Who advocates for kids who are told their injuries are diseases?

Bridge of Sighs

Mothers are the necessity of invention.

Bill Watterson

I am faced with the reality that my son has been a victim of Crimes Against Humanity, the most likely outcome is that his health will continue to decline... I write my blogs and share our story in the hope that doing so may prevent another child from experiencing the same horrific mis-treatment. It is a duty that is painfully difficult. What was done to my son has had a traumatic impact on all of us. There are times I feel like I don't want to meet anyone else; I have met enough people to last me a lifetime already. 

My traumatized child was repeatedly re-traumatized by mental health professionals with seeming impunity. The greatest risks he faces today are the risks posed by mental health and social service "professionals" and their "medical instruments." These systems have no accountability; no interest in holding employees and contracted providers accountable for harm done, even if they commit crimes. This is the system that placed him in what they knew to be a "bad" foster home, and years later allowed him to be used without Informed Consent, in spite of my protests in Federally Funded neuroleptic drug trials that were seeding trials conducted with the purpose of seeking FDA approval for pediatric use of the drugs trialed. 

In the interim, between being a victim of violent crime in foster care, and being used as a guinea pig in a state-run  psychiatric facility, he was a Risperdal victim.  His "treatment" broke State, Federal and International Laws, broke my son's spirit and broke my heart. The federally-funded researcher is still in a position of authority, still in a position to harm other children in the same way he harmed my son. The man wrote practice parameters for every diagnosis children in this state are prescribed drugs off label for, and all of them recommend using psychotropic drugs off label, i.e. experimentally.  Children and their parents are told the diagnoses are caused by a disease or genetic defect-- in spite of the fact no actual disease or defect has been identified in the diagnostic process. 

This is a story they are told to gain their cooperation to be 'treatment compliant.'  It's a ploy, a method used to coerce and to control. It is the very definition of fraud. Washington State has determined that instead of giving children the care, the understanding and the support they desperately need; we will tell them they have diseases, we will give them drugs that may cause diseases, may disable them, and that may ultimately take their lives. Washington State is dedicated to this mental health "care" model. The state adopted TMAP; and hired John Chiles, MD, who is the author of the schizophrenia portion of TMAP. Chiles was paid $151,284.73 by Janssen, a subsidiary of Johnson and Johnson, the makers of Risperdal and one of the companies involved in developing TMAP. Washington State hired Chiles after the nature of TMAP was known; after TMAP had been discredited. 

TMAP is a marketing scheme, not an Evidence-Based practice. 

1 Boring Old Man

I continue to write my blogs and do what I can to draw attention to the fraud and corruption behind psychotropic drugs in general, psychiatric abuse and what was done to my son; I am hoping it will prevent the same thing from being done to anyone else. The systemic flaws and public policies which allowed and even caused the horrific mistreatment my son, remain unchanged. The crimes in which my son was victimized have never been investigated by Law Enforcement; not a single one of the  perpetrators has been held legally responsible, or experienced any consequences for their conduct. I can't help but worry about the kids who are abused, neglected and traumatized who end up in state care needing help for dealing with the reality of what has happened to them. How can not having their needs met or being abused give a kid a disease? Compassion, kindness, unconditional love i.e. providing for physical, emotional and security needs consistently is therapeutic treatment. 

Who advocates for kids who are told their injuries are diseases?

A MadMother

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

Washington State to get $4.6 million of the $181 million from J&J

What about the primary victims?

via seattlepi.com:

Johnson & Johnson subsidiary to pay record amount to settle off-label marketing charges for antipsychotic drugs

Posted by Rita R. Robison on August 30, 2012 at 5:40 pm

"Attorneys general in 37 states reached a record $181 million dollar settlement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. They allege that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega.

"The lawsuit charges that Janssen engaged in unfair and deceptive practices when it promoted the antipsychotic drugs for unapproved or off-label uses.

"Washington state will receive more than $4.6 million to be used for enforcement and grants that will benefit people who suffer from the conditions the drugs were illegally marketed for, Washington State Attorney General Rob McKenna said in a statement" Rita R. Robison

No offense to Ms. Robison, but the alarm on my detector is shrieking...

Ms. Robison posted this comment to her article:

"These drugs, which have serious side effects, were market(sic) for treating kids and seniors, although the drug company had no evidence the drugs were effective for these age groups." 

via Seattle Times:

Originally published Thursday, August 30, 2012 at 3:02 PM

Business Highlights
NY AG: Janssen pays $181M over drug marketing

"ALBANY, N.Y. (AP) - Janssen Pharmaceuticals Inc. and parent company Johnson & Johnson on Thursday announced a $181 million settlement with 36 states and the District of Columbia over charges of marketing anti-psychotic drugs for non-approved uses.

"New York Attorney General Eric Schneiderman, representing one of the states involved, claimed in a court filing that Janssen engaged in deceptive practices from 1998 to at least 2004 in the marketing of the drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. The multistate settlement comes amid a similar federal case that is still pending."

Schneiderman said the company promoted "off-label" uses of the drugs not approved by the Food and Drug Administration. For instance, Janssen is accused of promoting Risperdal, which is used to treat schizophrenia and other mental illnesses, for non-approved uses including dementia, anger management and anxiety. Janssen rewarded doctors who prescribed and promoted Risperdal for unapproved uses with lucrative consulting agreements, according to Schneiderman's complaint. 

(emphasis mine) here

I would only add, not only did the drug complany have no evidence the drugs were effective for any "off label" uses; J&J had no evidence the drugs were SAFE for children or the elderly...
I'd be a whole lot happier to read that primary victims will be helped to recover from their iatrogenic injuries...some of the victims were children...one of them, is my son...

Does anyone besides me wonder, how many children are on Risperdal in Washington State right now? How many children are still being prescribed Risperdal (or any other neuroleptic drug) "off label"?

Seeding Trials planned in an effort to validate current clinical practice

On April 27th I wrote about the Army's Surgeon General, warning against the use of neuroleptic and other psychotropic drugs to treat the symptoms of PTSD. Today, I see a link to Army launches study of PTSD Meds on the Mad in America site---I can't help but think this is a response to the Army Surgeon General's office backing away from it's long standing endorsement of using psychotropic drugs to treat PTSD. Herbert Coley, civilian chief of staff of the Army's Medical Command issued a memo citing lack of efficacy and the serious risks of using neuroleptic and other addictive neurotoxins as the reason for issuing a warning against using psychiatric drugs to treat PTSD. This current announcement was made initially at the American Psychiatric Association's meeting in Philadelphia on May 5th by Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, and reported in Air Force Times appears to be announcing a plan to conduct 'seeding trials.' Seeding Trials are drug trials conducted with the primary goal of validating 'off-label' prescribing practices, gaining FDA approval to use a drug for a different symptom, and EXPAND THE DRUG MARKET. Obviously, this is unethical, This decision announced at the APA convention should be recognized as a decision to continue serving the profit interests of the drug industry, it cannot be a decision made with the well-being and recovery of Veterans experiencing PTSD as the primary focus. I wonder if Veteran's recovery was considered at all...

I cannot help but be amazed at how openly it is being acknowledged that the drugs used 'off-label' to treat PTSD without any definitive evidence to support using the drugs this way; is in fact a Standard Practice.  Using psychiatric drugs 'off-label' is not a decision  based on objective scientific data or ethical medical standards; it is based on Standard Practices and practice parameters which were adopted in the absence of objective, empirical evidence to support or validate them; ignoring fundamental, ethical medical principles.  Specifically, the principle that treatments used in Standard Practice are supposed to be derived from valid evidence of efficacy...including a risk profile which is justified by the actual benefits achieved.  The article in the Air Force Times makes it crystal clear that the treatment of PTSD for Veterans with neurotoxic psychiatric drugs is not now, and has never been based on Scientific Evidence or sound medical judgement.  

It is Human Experimentation to use drugs or other  treatments without valid evidence of effectiveness  and safety... This means that ethical medical principles are not being used when psychiatric drugs are prescribed 'off-label.'   Psychiatric treatment using drugs "off-label" that is not based on any valid or relevant evidence ignores sound medical reasoning altogether.  Small wonder the  bio-disease paradigm is an abject failure in terms of providing ethical, effective patient-centered care. Ethical clinical care requires that treatment decisions be based on ethical medical principles.  Fundamental principles of providing ethical clinical care require a clinician's primary focus be the individual patient's best interest.  This requires an honest dialogue which is respectful and honest. A professional has a duty to fully inform the patient about the diagnosis and the treatment options, which includes doing nothing; i.e. no treatment.  Informed Consent must be obtained without coercion or fraudulent claims and informing the patient about the potential risks and the possible benefits truthfully; and includes supporting the person who makes the decision to consult others of their own choosing.  Informed Consent is obtained prior to treatment starting, and is it is not a final decision; but is supposed to be an ongoing dialogue. Consent can be withdrawn without fear of or threat of punitive action, coercion or abuse of authority.

Three sentences in the article in particular indicate that treatment of PTSD with psychiatric drugs is without scientific validity; making it experimental treatment:

1. "But little data exists on which “off-label” medications work and which don’t."  

2. "Physicians still assess their patients and treat their symptoms based on their own medical experience as well as patient history and treatment preferences." 

3. “We’re trying to advance the science to catch up with clinical practice,” Wynn said. “This effort will seek to provide clinicians with a higher level of evidence when choosing a drug.” 

Theoretically, treatments used in Standard Practice are derived from scientific evidence, e.g. BASED on empirical evidence that a drug is safe and efficacious treatment for the condition it is being prescribed for; with the data supported by subjective observation and opinion.  In the biomedical paradigm of psychiatric care, standard treatment recommendations are overly reliant upon and sometimes entirely derived from subjective opinions.  A consensus of even well-educated opinions is no substitute for scientific evidence, and pretending that it is is ethically and morally reprehensible.   Clinical treatment "standard practices" are often not supported by the evidence; in some cases, the treatment is contraindicated by the clinical trial data making it unethical and unnecessarily risky. 

Psychiatry is using a bio-medical paradigm not grounded in valid research findings

or based on ethical medical principles.

  

via Air Force Times: 

By Patricia Kime - Staff writer
Posted : Tuesday May 8, 2012 16:21:49 EDT

Military and Veterans Affairs Department physicians often prescribe medication to ease the symptoms of combat-related post-traumatic stress disorder, even though only two antidepressants — Paxil and Zoloft — are approved specifically by the Food and Drug Administration to treat the disorder.

But little data exists on which “off-label” medications work and which don’t. 

The Army is hoping to change this, launching a major research initiative next year on the effectiveness of commonly prescribed medications for PTSD.

Speaking at the American Psychiatric Association meeting in Philadelphia on Monday, Army Maj. Gary Wynn of the Walter Reed Army Institute of Research and Col. David Benedik, associate director for the Center for the Study of Traumatic Stress at the Uniformed Services University of the Health Sciences, said the service will start clinical trials next year to evaluate commonly prescribed PTSD medications such as the antidepressant Cymbalta, mirtazapine, prazosin, and atypical antipsychotics like Seroquel.

VA and the Defense Department published joint guidelines in 2010 to provide doctors with assessments of the known research on many psychiatric medications used for PTSD.

But the guidance, which recommends strongly against the use of benzodiazapines like Valium and Xanax and several other medications, is not absolute. Physicians still assess their patients and treat their symptoms based on their own medical experience as well as patient history and treatment preferences.

Often this means prescribing medications developed to treat other mental conditions.

The Army research will test commonly prescribed medications over the next several years at multiple sites with hundreds of service members and veterans.

“We’re trying to advance the science to catch up with clinical practice,” Wynn said. “This effort will seek to provide clinicians with a higher level of evidence when choosing a drug.”

Wynn and Benedik hope their efforts will lead to better treatments for PTSD in both combat veterans and civilians.

“For pharmaceuticals that show benefits in treating combat-related PTSD, the Department of Defense may work toward a new indication or change in labeling,” Wynn said.

Published results from the first trial are expected by 2016.

First-Line Pharmacological Treatment For PTSD: Developed From Insufficient Evidence

Do neuroleptics like Seroquel and Risperdal, have a valid medical purpose used "off-label"?

Champions of Change? God Bless America and Protect Her Defenders...

FYI:

I'm certain my soul has turned into steel...

It is difficult, if not impossible, to reconcile the impact of so-called, psychiatric 'medical treatment' on my son. The neuroleptic and other psychotropic drugs have had, and continue to have, a devastating impact on his over-all health and functioning. I don't believe it is, or ever was, right or good treatment; nor do I believe any longer that the treatment was ever intended to be for his benefit.  I am only a mother, not a doctor or social worker.  I know that harm is not 'help;' it never was.  My son's "treatment" was inhumane, it never seemed that the primary focus of any psychiatrist prescribing drugs was doing what was in my son's best interest.  My precious son, Isaac, was first a victim of violent crime; then a Risperdal victim, which caused him further trauma; ultimately, he was used in Federally funded neuroleptic Drug Trials and disabled before he was an adult...

I was never asked if I wanted to sacrifice my traumatized son on the altar of corporate greed. No one asked me if Jon McClellan could use my son as a guinea pig. Quack Master Jack said he didn't need my approval or consent, he told me repeatedly I had NO SAY, because my son was 13 and that talking to me at all was a "courtesy."  Quack Master Jack needed only his own approval when he was an co-investigator funded by NIMH in the TEOSS seeding trials. The TEOSS drug trial was conducted to support FDA approval, in order to expand the neuroleptic drug market, but failed to support the use of any of the drugs trialed. Quack Master Jack didn't have time to quack to me in order to obtain my Informed Consent for my son to be used in the TEOSS drug trials. McClellan sure didn't seem to know what human rights are or even care that he was inflicting additional trauma on a trauma victim. I wonder if Jon McClellan cares that my son describes his "care" as "torture?"  I somehow doubt that he does.

FDA AERS

Year	Death	Serious
2000	19,445	153,818
2001	23,988	166,384
2002	28,181	159,000
2003	35,173	177,008
2004	34,928	199,510
2005	40,238	257,604
2006	37,465	265,130
2007	36,834	273,276
2008	49,958	319,741
2009	63,846	373,535
2010	82,724	471,291

"Johnson & Johnson worked closely with NAMI and other advocacy groups in order 

to integrate pro-atypical information into their literature and speaking engagements."

Craig Malisow in Down the Hatch

My son is ill again, physically. This is the third time in less than a year and a half. He so rarely got sick, that it seemed like he never got sick when he was a kid...It is so very hard to accept the reality of why it is so different now. He has a much better attitude than I. He pities those who did this to him. A couple days ago, he told me, "I know I'm sick because of the drugs, and I'm ok with it." I think he was trying to make me feel better. I can't help but to be utterly and completely grief-stricken and so very, very angry. Seeing my son's health continue to decline, with no way of stopping it; I have no hope of getting anything close to adequate medical care for the iatrogenic cognitive impairment and neurological damage that the drugs continue to cause my precious son. There's nothing fucking thing right about it. 

via Nature.com
US bioethics panel urges stronger protections for human subjects
Present regulations are adequate but not optimal, report says.
Meredith Wadman 15 December 2011

"The report says that individual subjects should be compensated for their medical care if they are harmed during research, and that the government should study whether “a national system of compensation or treatment for research-related injuries” may be required. The idea is not new a new one: in 2002, the Institute of Medicine, part of the US National Academies in Washington DC, also called for compensation of research-related injuries. For some, the Bioethics Commission report does not do enough to advance the issue.

“No recommendation is made for the sponsor to pay or for the government to pay, just a recommendation to study the issue. This simply shelves the issue of compensation to collect dust,” says Vera Hassner Sharav, the president of the Alliance for Human Research Protections in New York.

"Gutmann says that the commission “unequivocally states that there is a strong ethical case” for compensation, a practice that is common to almost all other developed nations. But, she adds, “we also think it’s very important that the federal government study how best to create a system that would ensure such compensation. We want the government to get it right.” read the entire article here.

via HoustonPress

Down the Hatch: The Rothman Report
A scathing, 86-page report called out doctors who "subverted scientific integrity" for money.
Craig Malisow Wednesday, Dec 14 2011
"In its quest to quantify the collusion between Janssen and the proponents of the Texas Medication Algorithm Project, the Texas Attorney General commissioned David Rothman, a professor of social medicine at Columbia University's medical school, to produce an expert witness report. The resulting analysis, completed in October 2010, is an 86-page bitch-slap of doctors who Rothman says "subverted scientific integrity" in their rush to line their own pockets. Some highlights are listed below." read the rest here. 

I'd say, more than a 'bitch slap' is warranted...

but then, I am biased by experience... 

I'm certain my soul has turned into steel...

"Not Dark Yet"

Bob Dylan

Shadows are fallin' and I've been here all day

It's too hot to sleep and time is runnin' away

Feel like my soul has turned into steel

I've still got the scars that the sun didn't heal

There's not even room enough to be anywhere

It's not dark yet but it's gettin' there.

Well, my sense of humanity has gone down the drain

Behind every beautiful thing there's been some kind of pain

She wrote me a letter and she wrote it so kind

She put down in writin' what was in her mind

I just don't see why I should even care

It's not dark yet but it's gettin' there.

Well, I've been to London and I been to gay Paris

I've followed the river and I got to the sea

I've been down on the bottom of the world full of lies

I ain't lookin' for nothin' in anyone's eyes

Sometimes my burden is more than I can bear

It's not dark yet but it's gettin' there.

I was born here and I'll die here against my will

I know it looks like I'm movin' but I'm standin' still

Every nerve in my body is so naked and numb

I can't even remember what it was I came here to get away from

Don't even hear the murmur of a prayer

It's not dark yet but it's gettin' there. 

God help me...help me to help my son. Amen

first posted 12-16-2011

photo credit 

It is Criminal: Doctors Do Not Disclose Risks of Psychiatric Drugs

Isaac before Risperdal

Psychiatric Mythology: Evidence-Based Diagnosis and Treatment

The fraud and corruption of Johnson and Johnson, and all the other pharmaceutical industry thugs could not have been done without the willing participation of psychiatric researchers who conducted biased trials that were part of a drug marketing agenda, then published biased reports in 'peer- reviewed' professional journals.  The research was structured and conducted to serve the marketing agenda and profit goal of the Pharmaceutical industry. This formula became psychiatry's gold standard, since the marketing goals were spectacularly achieved using these unethical methods. Apparently, the ends justified the means.

I am disgusted by the errors of attribution, flawed methodology, half-truths and outright lies; essentially what amounts to 'psychiatric mythology' which was developed to 'standardize' psychiatric diagnoses and psycho-pharmacological treatment.  All of this was done to institute a bio-disease paradigm in the diagnosis and treatment of emotional and behavioral issues within the publicly-funded mental health treatment system.  No genetic defect or dysfunction, no neuro-biological pathology of known or unknown etiology had been identified; yet this lack of empirical evidence does not stop these 'doctors' of psychiatry from authoritatively stating psychiatry is in fact treating 'brain diseases' that are incurable.  Why would this be done?

Apparently, it is done to coerce and manipulate patients and their family members to gain their cooperation and maintain 'treatment compliance.'  Stating false claims in order to alter through the use of deception a person's behavior, is fraud.  It is a crime. It is not an ethical method to medically diagnosis and prescribe medical treatment to a suffering patient.

Misinformation that psychiatrists have falsely claimed is medical knowledge, specifically, the disease metaphor; i.e. Psychiatric Mythology, became the foundation of Public Policy for the diagnosis and treatment of emotional and behavioral difficulties and extreme states experienced by people given psychiatric labels.  Legislation depriving people with psychiatric diagnoses of basic Human Rights and individual protections people without a psychiatric label take for granted have been passed in 46 states.  Rules of Evidence are not required, so gossip, innuendo and even perjury are allowed.

Involuntary Treatment Laws "deal with the mentally ill" who are purported by bio-psychiatry to lack insight; and cannot know whether psychiatric treatment hurts or helps them--and supposedly this is the primary reason they must be forced by Court Order.  Bio-psychiatry practitioners and advocates who are proponents of drugging emotional distress and behavioral difficulties as diseases, are seemingly not troubled by the fact that a significant percentage of individuals diagnosed and targeted by their teratogenic treatment, do not experience an appreciable reduction in symptoms from taking these dangerous psychiatric drugs; but do experience the iatrogenic diseases and disabilities.  The traumatizing, disabling effects of the drugs and the dishonest, coercive and manipulative methods used to gain 'treatment compliance' are why treatment is unwanted and avoided by some; OBVIOUSLY.  It is unwanted and avoided according to these all-knowing (apparently psychic) 'medical advocates,' and psychiatrists, because their unwilling patients/victims just  'don't know what's good for them!'

Proponents of forced treatment do not even acknowledge the people who have experienced lasting harm from the negative impact of neuroleptic and other psychiatric drugs; or the coercive and manipulative methods used to trick patients.  The fact that some, like my son, have been "treated" without consent, into states of cognitive and physical disability; is criminal.  This damage is compounded by the failure of mainstream advocacy groups, Federally-funded Protection and Advocacy Attorneys, and Assigned Counsel, appointed to represent people facing involuntary psychiatric treatment under Court Order. Rarely, are victims of psychiatric abuse even acknowledged by public servants who have a duty to protect, serve and defend them.

Pretending that these survivors, and those who were killed by inefficacious and unethical "treatment" do not exist, is morally reprehensible.  My son is real, and so are all people with a psychiatric diagnosis; whether they are complying with psychiatric treatment or not.  All of us have Human Rights.  A psychiatrist claiming an ability to discern accurately when and if a diagnosed person lacks insight, is ludicrous.  There is no statistically relevant empirical data, evidence of 'disease' so this merely a ploy used to justify abuse of authority.  Standard Practice and Treatment Protocols and algorithms are based on subjective opinions, e.g. biases, errors of attribution and prejudices included.  Psychiatry continues to use treatments and treatment protocols developed using fraudulently collected and/or reported data.  This being the case, the assertion that treatment refusal is due to a person's 'lack of insight' is truly ironic; ethically questionable, all things considered.

Neuroleptics are called antipsychotics, but for a significant percentage of people who experience symptoms of psychosis, the drugs are in fact not 'anti' psychotic.  Neuroleptics are in fact terotagenic drugs which can cause multiple biological systems to become dysfunctional, and lead to disability.  The risk of taking neuroleptics includes sudden death--even children have died from taking them as prescribed.  Long term use can cause brain damage and decrease life expectancy by 25 to 30 years.   Proponents of forced treatment also do not talk about the rampant fraud in academia, which has propelled the prescribing of the newest and most expensive drugs to Medicaid and Medicare beneficiaries, often "off-label" in spite of the lack evidence justifying making indiscrimiate use of teratogenic drugs off-label a "Standard Practice."  This is not ethical  medicine; and when 'off-label" prescribing is coupled with not being given complete and accurate and information, it is a massive betrayal of trust and negligent.

My son is now twenty-four and the vast majority of the drugs he was prescribed as a minor, were prescribed "off label" and not approved for pediatric use at all---I was not ever told this; nor was I ever told of the risks which are inherent with neuroleptic use:  Risks which include dependency, diabetes, obesity, heart damage, neurological impairment, cognitive impairment, akasthisia, and tardive dyskinisia.  The deleterious effects of the drugs on my son's health were attributed to his diagnosis; even though the adverse effects are documented in the professional literature.  I am so angry about the enormous betrayal of being lied to by psychiatrists, who are 'medical professionals.'   The negative effects of neuroleptic and other psychotropic drugs were the symptoms used by psychiatrists to diagnose co-morbid metal illnesses and behavioral disorders.

There is no doubt that there are those who need help accessing effective treatment and support services.  Proponents of "Court Ordered Treatment" whether inpatient or in the community focus on psychiatric drugs, to the exclusion of other Evidence-Based treatments and rehabilitative services.  Psychiatric drugs are not "safe" in any real sense of the word, and are not medicinal treatment in the Hippocratic tradition. They are more like the drugs used in oncology yet are marketed widely to particularly vulnerable people as safe and effective.  All psychiatric drugs have very serious risks; risks which are rarely discussed openly and honestly.  To this day neither I, nor my now grown son has ever had even one respectful or honest dialogue with a psychiatrist who has ever prescribed neuroleptic or other psycho-active drugs to him.

The facts are ugly:

1. The risks, once known, were hidden on purpose--lied about and covered up by psychiatric researchers, and their pharmaceutical industry co-conspirators and financial benefactors.

2.  The harm done to countless thousands (millions actually) has in fact been minimized as the "necessary risks" of "effective treatment," or worse, dismissed as, "tolerable side effects" by psychiatrists and others who prescribed the drugs.  This is why it is claimed the patients lack insight, and their complaints are ignored !

3.  The drugs are dangerous; neuroleptics and other psychiatric drugs are known to cause cognitive and intellectual decline---and we Court Order people to take them based on psychiatric fraud and deception. Brain damage occurs with long-term use;  I've seen it happen, suddenly and profoundly as well...

Given these facts, how is is justifiable that children are being given these drugs, to treat symptoms for which there is no valid medical justification to prescribe them?  Why are parents and guardians, or adult patients not being given the information necessary to determine whether the potential benefits outweigh the possible risks?  Given the serious risks, how can we as a society, justify forcing people to take drugs which can cause them to develop serious debilitating  metabolic and neurological illnesses, that can be disabling, and lead to early and/or sudden death?  This does not "help" those who are vulnerable, in crisis, and in need of kind, compassionate care.  It is not "helpful" to force people to take drugs which cause parasympathetic nervous system dysfunction, cognitive decline, and limits their abilities; putting them at further risk of sudden or early death.  Just because a drug is prescribed, does not mean the drug is "medicinal," "therapeutic," or even ethical treatment that is being provided to the patient.  Without Informed Consent, it is in fact criminal.

I am only a mother whose child was prescribed neuroleptic drugs "off-label" in a surreal horror story:  It is as if some very twisted combination of a marketing scheme and a pseudo-medical horror movie about Psychiatry. The goal is convince people that symptoms of emotional distress and behavioral difficulties, regardless of their etiology, are symptoms of a life-long biological diseases or genetic dysfunction.  The "treatment," is always drugs and/or electroshock which can and does cause disease and dysfunction.

Patients are purposely misinformed when they are told they have a disease or imbalance; then when drug-induced dysfunction is recognized it is attributed to the progression of the "disease."  Psychiatrists have told family members that their loved one with a psychiatric diagnosis has a "brain disease;" and just don't know they should take their medicine; they have 'no insight.' Telling parents and other family members that, 'the 'side effects' are unpleasant, but your loved one must take the drugs is a social control tactic.  Implicit is the idea/judgement/"support" to help you believe  you need to use manipulation and coercion; you need to lie to them,  'for their own good.'  Is it really surprising the lack of trust many people have for "mental health treatment providers" and for psychiatry? Why would anyone trust an individual who lies; let alone a group of professionals whose knowledge base is riddled with falsehoods and believe lying to and about patients is ethical and is necessary to implement a 'medical treatment' strategy?  These are in reality, bullying tactics.

Outcomes for the patients are obviously not as important as never questioning the medical model of "mental health treatment," and being compliant---Consent, or a psychiatrist or other mental health professional ethically sharing information about the risks and potential benefits of psychiatric drugs with adult patients or parents of diagnosed children, is not necessary---people with a psychiatric diagnosis, and family advocates are to be told no more than necessary to gain compliance with the chosen Practice Parameter and Treatment Protocol.  Charles Huffine, M.D. told me, "Parents who objected to medical treatment they (psychiatrists) would see as at best ill informed and at worst impaired themselves."

There it is Ladies and Gentlemen: The unvarnished, unadulterated truth of bio-psychiatry:  Parents who do not agree to drug their children must be ill-informed, or impaired themselves!  Ironic really, when you consider parents may be ill-informed by the psychiatrists who are making this judgment! Implicit in this statement is the belief that parents have no right to refuse consent to psychiatric treatment on behalf of their children, or make any decision for their child which a psychiatrist or other mental health professional disagrees with.   In effect, the risk vs. benefit analysis and consent is solely the provenance of the psychiatrist, or other mental health professional?!

When a prescriber fails to fully inform adult patients and/or parents of child and adolescent patients, and fails to engage the diagnosed person and support persons in an honest, respectful dialog which culminates in a shared decision---there is no consent, let alone, Informed Consent!  In this way, parents are effectively denied their Constitutional Rights as parents to make medical decisions about mental health treatment for their children without Due Process of Law; and often don't even know this has occurred. In fact it continues to be a threat---even though I have the legal authority to act on my son's behalf, when he is unable.  Parental Rights and Family Rights mean nothing to some psychiatrists or "mental health professionals" in my experience.

Judi Chamberlin Debates E. Fuller Torrey



First published June 11, 2011 edited and links added