adverse events are NOT "confidential commercial information"

via AllTrials:

 AbbVie rep says info on adverse effects of drugs should be considered commercially confidential

6th September 2013

"On the one hand, some companies such as GSK and Roche are putting a lot of work into making a change to culture and practice that would see transparency become the global norm in drug trials...One of those companies, AbbVie, has just argued that information about adverse effects of drugs “is confidential commercial information because if released other companies could use it to help them get products approved.”" read the rest here

this three minute clip is chilling...

powered by Splicd.com hap tip: Thanks to 1 Boring Old Man a deal-breaker?…"something everyone will want to read."

Conflicts of Interest in children's psychotropic clinical trials

via The Alliance for Human Research Protection:

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

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

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

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

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

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

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

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

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

via Alliance for Human Research Protection:

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

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

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

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

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

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

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

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

via National Association  of Medicaid Directors 2012 Fall Conference:

The Problem

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

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

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

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

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

• States need tools to address these needs.Key Concerns

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

• High psychotropic use and polypharmacy in foster youth.

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

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

• Monitoring and managing metabolic risks of antipsychotics.

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

• MH assessment and services consistent with treatment.

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

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

Without justice, society elevates criminals into virtual Masters over their victims

I guess that rumor that Washington State is going to get rid of the MPC providers  may have been true...I wonder if it is because they won a Lawsuit against the State.  MPC providers are owed back pay with interest. Washington State has ignored the  2007 Washington State Supreme Court Jenkins v DSHS decision the entire time I have been my son's provider, I am owed a few grand in back pay myself...

The Department ignored several Court Orders to act on Isaac's behalf when I brought him home from Child Study and Treatment Center when he was almost 17 in 2005. 

It's how DSHS "does business."

I am utterly disgusted with the behavior of the local Home and Community Services,HCS, and SE Washington Aging and Long Term Care, ALTC. The statements and the actions of Dirk at HCS and the ALTC staff are defamatory and slanderous. Once I had faxed my hand written affidavit correcting the BCCU report which states I had answered question 13 with a "yes," I contacted the ALTC office to be informed by Jackie Klingle that a determination had been made that I am no longer allowed to be Isaac's care provider. She refused to give me any reason whatsoever for the determination. Question 13: "Have you ever has a contract and/or license to care for children, juveniles, or adults denied, terminated, revoked, relinquished, or suspended?"

I was first made aware that there was a problem on the 30th of October when a potential in-home care client called me and told me that Dirk at the Home and Community Care office had called her and told her that I could not be her care provider because my license was revoked due to committing  a crime. I knew that this was not true, and I am horrified that such a thing was told to a potential client. There is no excuse for such unprofessional conduct. I turned in a background authorization to the ALTC office and one to the HCS office on the 24th of October. The ALTC BCCU report is dated the 25th, and there is a note written on it that says, "11/17/2006 Wapato HCS" next to the highlighted statement that I answered "yes" to question 13.  I became Isaac's care provider in 2008, and the BCCU report dated 11/25/2008 makes no mention of question 13.  The HCS ran their report on the 26th. It is more than a little suspicious that in the 4 and 5 day interim between the reports being printed and Dirk slandering me to a client, neither agency made any effort to contact me. 

On the 30th I went to the HCS office to speak to Dirk who was less than polite. He proceeded to tell me three different stories as to why I was not going to be allowed to be a care provider for a potential client who has a care assessment for 29 hours of assistance a month. First, Dirk stated I had been terminated because of my 1994 conviction for 4th degree assault. When I informed him that I knew the conviction was not a disqualifying crime, he then claimed I was disqualified because the BCCU report which states that I had answered "yes" to question 13. It was this second story that made me realize he was lying and he was pissed as hell, although entirely calm. So I pointedly asked who he was and asked him why he had failed to even introduce himself. Pointing out his rudeness, made him angrier. The man did not introduce himself, and he was rude and condescending---it was entirely obvious that he had no respect for me whatsoever; it was equally obvious that he felt no need to hide his contempt. Ultimately, he seemed to become be even more unhappy when I pointed out that he had not even bothered to do any fact checking; and as a result he had stated things which he did not know to be true, that in fact are not true. He did not appreciate me pointing out his blatantly unethical behavior. I asked him if he thought there was anything wrong with telling a client that I had lost my license, when this was not a fact he knew to be true. He said he didn't. It was then that Dirk told me the third story he offered as a reason for terminating my contract. Derik stated that I can not be a provider because my birth mother's ALTC case manager (I forget her name) put me on a Status 4 list(whatever that is).  He told me that he had been reading a report that said I had abandoned my birth mother when I was her in-home care provider, and that I had robbed her and left her barefoot at the mission. These are spurious allegations, and Dirk basically sneered at me while he spat out that he had been reading how I had allegedly committed horrific crimes including abandonment when he was told I was at the HCS office to see him. If this were true why was there no criminal complaint filed with Law Enforcement as required by Law? There was no criminal investigation or prosecution. I was never served with any legal notice that the Department had done an investigation or that the Department had substantiated any of what Dirk told me my birth-mother's ALTC case manager had allegedly reported. I've never been served with any legal notice that a determination has been made which disqualifies me from being a care provider.  

I am sick and tired of DSHS employees who are unethical, dishonest and disrespectful and who abuse their authority with impunity. I am tired of being disrespected and treated as if I am not a human being worthy of respect, but after twenty years, I'm used to it---I figure the fact it still makes me sick, is a good thing. At least I know it's wrong; and I don't have Stockholm syndrome. But this is not about me, or how I have been repeatedly traumatized; it is about my son, Isaac and the countless felony and misdemeanor crimes, ethics violations committed by public servants whose unprofessional behavior and rude disrespectful treatment repeatedly traumatized my son and put him in harm's way again and again. This is about State employees and contracted "care" providers who abuse their authority with impunity due to a lack of accountability that is the accepted norm in the unethical culture entrenched within publicly funded child welfare, mental mental and social service programs. This is about the abject failure to protect or defend children and vulnerable adults who are victimized. 

I find it truly ironic that not once has anyone been held accountable in 20+ years for crimes committed victimizing my son, Isaac. No matter the crime, whether it be assault, battery, medical neglect, using perjury to civilly detain and commit him, or using him in human experimentation---which he described as being tortured. My son thought he'd been kidnapped; and in effect, he was. Washington State made him a Ward of the State in order to claim Federal Child Welfare funds; it's called fraud.  DSHS has repeatedly violated my son's Civil Rights, and has repeatedly violated my Civil Rights, for over twenty years. I want to know why in the hell is it permissible for DSHS to violate the Law, and violate my son's Constitutional Rights on a regular basis, ever since he was beat up and put in a closet while in a foster care when he was three years old? I want to know why it is permissible for numerous Case Workers and mental health "professionals" to perjure themselves in Superior Court? Tracy Dalton in King County, Doug Savelesky, Nancy Sherman, and Jeffrey Jennings, in Yakima County, and Leah Landis in Pierce County these are State employees and mental health professionals who perjured themselves in the last 17 years in Washington's Superior Courts while acting as agents of the State of Washington, Under Color of Law. Gary Peterson lied and cost the State $30,000; he experienced no consequences and was allowed to abuse his authority to punish us over and over again...The Medical Director of CSTC, Jon McClellan, tortured my son; treated my son as if he were a lab animal in Drug Trials. In doing so, he broke State, Federal and International Law. He ultimately "treated" my once brilliant son into a state of profound iatrogenic disability. He is still the Medical Director of CSTC; he is still teaching at UW; and most of all, he still belongs in a Federal Prison. 

The cock and bull story alleging that I have been terminated as a care provider because I allegedly committed heinous crimes that were never reported, investigated or prosecuted is particularly cruel all things considered. 

My hope is that writing about these events will compel others to act on the knowledge that public employees and contracted "care" providers must be accountable for violating the law. If public employees abuse the authority vested in them by society, they must be held accountable by society. If they commit crimes, they must be criminally prosecuted. It is not possible to act in the "best interests" of vulnerable children and adults by committing crimes and being deceitful; it does not serve the public good to allow such criminal behavior to go unpunished. Without justice, society elevates criminals into virtual Masters over their victims, while leaving their victims defenseless. Society becomes complicit by remaining silent. Public employees who are not accountable will victimize those we entrust them to serve with impunity. 

Psychiatry: focused on defending unethical research and clinical care standards instead of real world outcomes

"Currently, there are no pharmacological or psychosocial therapies with enough evidence in youth samples to meet the standards for empirically-supported treatments as defined by Chambless & Hollon (1998; Brown et al., 2008; McClellan & Werry, 2001)." here

via NYTimes:
Use of Antipsychotics in Children Is Criticized
By GARDINER HARRIS

Published: November 18, 2008

a few excerpts:

"From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal."

"At least 11 of the deaths were children whose treatment with Risperdal was unapproved by the F.D.A. Once the agency approves a medicine for a particular condition, doctors are free to prescribe it for other problems."

"Panel members said they had for years been concerned about the effects of Risperdal and similar medicines, but F.D.A. officials said no studies had been done to test the drugs’ long-term safety."

"Dr. Dure said he was concerned that doctors often failed to recognize the movement disorders, including tardive dyskinesia and dystonia, that can result from using these medicines."

“I have a bias that extra-pyramidal side effects are being under-recognized with these agents,” Dr. Dure said.

"Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects." here

via Archives of General Psychiatry:

Original Article | June 2006

National Trends in the Outpatient Treatment of Children and Adolescents With Antipsychotic Drugs

Mark Olfson, MD, MPH; Carlos Blanco, MD, PhD; Linxu Liu, PhD; Carmen Moreno, MD; Gonzalo Laje, MD

an excerpt:

Child and adolescent mental health visits that include antipsychotic treatment occur disproportionately among publicly rather than privately insured patients. After adjusting for patient diagnosis and other background characteristics, mental health visits by publicly insured children and adolescents were significantly more likely to include prescription of an antipsychotic medication. This finding is in line with higher youth antipsychotic prescription utilization among populations covered by Medicaid^2 - 3 compared with commercially insured populations.⁴ The basis of this is unknown but may relate to differences in public and private payer reimbursement schedules for pharmacologic or psychological interventions, insurance-related variations in parent or child acceptance of antipsychotic treatment, or selection of patients in different insurance plans by physicians for treatment. Because Medicaid covers children and adolescents with Social Security Income and young people who are medically needy or in foster care, illness severity may account for differences in antipsychotic medication use across insurance groups.²⁹ Additional study is needed to understand the factors that contribute to insurance-related differences in child and adolescent antipsychotic treatment.

Approximately one third of the child and adolescent visits with prescription of antipsychotic medications were by young people with mood disorders. In addition, approximately one third of antipsychotic visits included coprescription of an antidepressant medication and one third included coprescription of a mood stabilizer. At present, there is a dearth of empirical evidence to support these prescribing patterns. 

In office-based practice, almost all of the antipsychotic treatment among children and adolescents is provided by psychiatrists. Although the NAMCS data suggest that primary care physicians and other nonpsychiatrist physicians provide care in approximately half of the youth mental health visits, they seldom prescribe antipsychotic medications. (emphasis mine) here

via American Journal of Psychiatry:

November 01, 2008 

Double-Blind Comparison of First- and Second-Generation Antipsychotics in Early-Onset Schizophrenia and Schizo-affective Disorder: Findings From the Treatment of Early-Onset Schizophrenia Spectrum Disorders (TEOSS) Study

Linmarie Sikich; Jean A. Frazier; Jon McClellan; Robert L. Findling; Benedetto Vitiello; Louise Ritz; Denisse Ambler; Madeline Puglia; Ann E. Maloney; Emily Michael; Sandra De Jong; Karen Slifka; Nancy Noyes; Stefanie Hlastala; Leslie Pierson; Nora K. McNamara; Denise Delporto-Bedoya; Robert Anderson; Robert M. Hamer; Jeffrey A. Lieberman

Am J Psychiatry 2008;165:1420-1431. doi: 10.1176/appi.ajp.2008.08050756

a couple of excerpts:
Finally, different choices could have been made with regard to the specific medications studied. At the time the trial was initiated, olanzapine was widely used in the pediatric population, whereas quetiapine had a small market share. Ziprasidone and aripiprazole, both of which may have fewer metabolic side effects, were introduced subsequent to the initiation of the study. Efforts to introduce them partway through the study were not supported by the FDA or NIMH. We also considered utilizing a placebo for comparison, as opposed to a first-generation antipsychotic. We expected that this would increase the demonstrated efficacy of the second-generation antipsychotics, but it would not address the fundamental comparative questions. Distributing the sample among four treatment conditions rather than three would also have reduced statistical power. We also considered requiring a drug-free baseline to minimize the likelihood of finding no apparent benefit of substituting one partially effective treatment for another. However, concerns about the long-term consequences of delaying effective treatment and associated recruitment difficulties argued against including a placebo treatment group or a drug-free baseline. At the time the study was initiated, there were significant ethical concerns about utilizing any first-generation antipsychotic in comparison with second-generation antipsychotics, because second-generation antipsychotic treatment was the standard of care for early-onset schizophrenia and schizoaffective disorder. We felt any traditional medication selected as a comparator would have to provide a strong potential advantage to maintain therapeutic equipoise. Molindone was chosen as the best option among first-generation antipsychotics based on its low propensity for both weight gain and extrapyramidal side effects. Despite this advantage, molindone is not commonly used in clinical practice. A more frequently used medication, such as perphenazine or haloperidol, might have facilitated comparison with adult studies and acceptance in the community. Failure to require a drug-free baseline may have reduced response rates and led to earlier treatment discontinuation.

Another potential limitation of the study is the 8-week duration of treatment. Different patterns of response or risk of side effects might have emerged over a longer trial. Some young people may require more extended therapy to adequately respond, and it is likely that some aspects of the illness, such as negative symptoms, neurocognitive function, and associated anxiety, may require longer periods to recover (44, 45). However, published standards of care for early-onset schizophrenia and schizoaffective disorder recommend the use of 6- to 8-week trials (1). A longer acute phase trial would have increased the risk of exposing subjects to prolonged ineffective treatment. Furthermore, antipsychotic medication trials in adults with schizophrenia suggest that nonresponse as early as 2–4 weeks after initiating treatment predicts nonresponse up to 12 weeks later (46–49).

The results question the nearly exclusive use of second-generation antipsychotics to treat early-onset schizophrenia and schizoaffective disorder. The safety findings related to weight gain and metabolic problems raise important public health concerns, given the widespread use of second-generation antipsychotics in youth for nonpsychotic disorders. here

Let's be real, using neuroleptic drugs for any psychiatric diagnosis is not supported by any definitive evidence; calling the drugs "effective treatment" is more than stretching the truth---Indeed, the evidence clearly demonstrates neuroleptic drugs are minimally effective for a small minority of children and adults experiencing symptoms of psychosis; and have significant disabling and fatal risks particularly for  children and the elderly.  The standards used in clinical practice are not supported by or derived from empirical data from clinical trials, or data collected from the decades long use of neuroleptic drugs off label in clinical practice---begging the question, how did prescribing these drugs to children "off label" become a "standard practice?"  This experimental use is a standard of care only because it was discussed, and adopted as a "standard" by psychiatrists. It is not because the prescription of neuroleptics is supported by, or derived from any empirical data of the safety or efficacy for the symtoms the drugs are being prescribed to children and youth to treat. In psychiatry, there are standards of care that are without support from any ethical scientific psychiatric research.  Since they are not derived from or supported by the evidence base, these so-called "standard practices" are not ethical medical standards. The drugs are used off label as a "standard" treatment due to the hubris of psychiatric professionals who have determined that consensus will suffice in place of the objective evidence that theoretically is required for a particular practice to become a clinical care "standard." 

I have been reading 'peer-reviewed' psychiatric journal articles for over ten years and I am still amazed at the lack of critical thinking exhibited by the psychiatrists who do the research and write the articles.  The utter lack of of ethical integrity of "RESEARCH PSYCHIATRISTS" is truly stunning.  The commonality is that all of them continue to repetitively state more evidence is needed to support psychiatric standards of care that are the standards psychiatrists disseminate to other professionals for clinical use; and teach to students and other medical professionals! When reporting trial results that don't support the standards used, which are the recommended 'first line treatments' that comprise the Standard of Care---does it not occur to any of these geniuses that the standards are not ethical medical standards!?  Apparently, psychiatric research and clinical practice requires no critical thought...

For example, in the TEOSS drug trials, 12% of patients enrolled were "effectively treated."  97 out of the either 116 or 119 enrolled experienced a serious adverse event; the Olanzapine arm was stopped due to the number of adverse events---At the time, Olanzpine was the most widely prescribed neuroleptic drug in the pediatrics population!  BUT there were no warnings for professionals to stop prescribing the drug to children...Exactly how many more children need to be subjected to what are harmful teratogenic neurotoxic drugs which may in fact disable and kill them, before "external forces" put a stop to these dorktors conducting research in their attempt to validate unethical standards of care? 

As a society we need to recognize that Human Experimentation on people given a psychiatric diagnosis is not an ethical standard of care; nor is it a benificent act. 

The BEST INTERESTS of the patient must come first---even if the patient is unpleasant, and even if we have been taught that the some psychiatric diagnoses mean that a patient's Human Rights can be ignored or revoked--in the interests of society... It is immoral, and it is unconstitutional.  It is also the same ignorant reasoning used to implement Eugenics laws in this country that brutalized tens of thousands, and unlike the Germans in WWII, we didn't keep track of those we killed.  America's program wasn't as 'successful' as Germany's, but it has left a stain.  Worse than that, the fundamental social control strategies and bigotry that propelled eugenics as public policy remain embedded in our publicly funded social service and mental health programs.  Sadly, the lessons learned have not remained in the general public's collective conscience...  

I believe the fact that medical care is supposed to be in the best interests of the patient, has been lost in the debate about how to help 'the seriously mentally ill' altogether.  Patients are being used as research fodder and Human Experimentation is standard psychiatric clinical practice.  In Medicine, a "standard practice" is theoretically supposed be derived from and well-supported by empirical evidence that is ethically gathered and reported in an unbiased manner.  In psychiatry, standards are discussed in committees and "validated" by a vote; these are not scientific methods, so the "standards" are unethical.  Without empirical evidence to support a particular "standard practice" or treatment protocol it is not a "standard of care," it is nothing more than an affirmative defense for psychiatric fraud and medical malpractice.  

The academic elite, Key Opinion Leaders who are members of the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry are unethical psychiatrists who are desperately defending what are obviously gross departures from ethical scientific methods and ethical medical practice, inexcusable errors in judgement, and blatant abuse of power and authority.  Ironically, these medical professionals are doing this while claiming it is not their ethical medical duty to treat the iatrogenic neurological impairments brain damage and physical diseases psychiatrists inflict upon their patients.  It is medical neglect; it is criminal.  Psychiatrists are doctors, doctors should treat the illnesses they cause instead of spending so much time defending their so-called "professional integrity."  Perhaps treating the iatrogenic illnesses and injuries they are causing will remove the scales of prejudice from their eyes...

It is certain that continuing to deny the iatrogenic harm psychiatrists are causing patients while simultaneously medically neglecting the victims and frantically tryiing to validate unethical clinical care standards with federally funded seeding trials, are desperate, dishonest acts that serve only to further undermine the integrity of psychiatry as a profession.  It's sheer hubris to vehemently defend unethical "standards of care" and "professional integrity," (which is sorely lacking) while maligning psychiatric survivors; adding insult to iatrogenic injury.  It's not possible to regain trust  with the same dishonest, unethical behavior that destroyed it. 

via Vitals NBCNews.com:
Docs: Antipsychotics often prescribed for 'problems of living'
by Sandra G. Boodman Kaiser Health News  March 18, 2012

"Adriane Fugh-Berman was stunned by the question: Two graduate students who had no symptoms of mental illness wondered if she thought they should take a powerful schizophrenia drug each had been prescribed to treat insomnia."

"In 2010 antipsychotic drugs racked up more than $16 billion in sales, according to IMS Health, a firm that tracks drug trends for the health-care industry. For the past three years they have ranked near or at the top of the best-selling classes of drugs, outstripping antidepressants and sometimes cholesterol medicines. A study published last year found that off-label antipsychotic prescriptions doubled between 1995 and 2008, from 4.4 million to 9 million. And a recent report by pharmacy benefits manager Medco estimated that the prevalence of the drugs' use among adults ballooned more than 169 percent between 2001 and 2010."

"Wayne Blackmon, a psychiatrist and lawyer who teaches at George Washington University Law School, said he commonly sees patients taking more than one antipsychotic, which raises the risk of side effects. Blackmon regards them as the "drugs du jour," too often prescribed for "problems of living. Somehow doctors have gotten it into their heads that this is an acceptable use." Physicians, he said, have a financial incentive to prescribe drugs, widely regarded as a much quicker fix than a time-intensive evaluation and nondrug treatments such as behavior therapy, which might not be covered by insurance."

"Medco is asking doctors to document that they have performed diabetes tests in patients taking the drugs. "Our intention here is to get doctors to reexamine prescriptions," Muzina said."

"In the short term, I don't see a change in this trend unless external forces intervene." here

Neurotrauma and Psychological Health Project and Cooperative Studies

Violating the Hippocratic Oath and the Oath to preserve and defend the Constitution.

Broken Warriors

via Stars and Stripes:

Army, VA partner for PTSD drug study

By COURTNEY MABEUS

The Frederick News-Post

Published: July 15, 2012

Studies show the average person with PTSD waits 12 years before being treated. Col. Charles Engel, a Walter Reed National Military Medical Center doctor, said each month 100,000 soldiers are screened for PTSD.

RUSSELL MIDORI/DVIDS

"An Army office at Fort Detrick and a veterans program are teaming up to study drugs that could help treat combat-related post-traumatic stress disorder.


"The U.S. Army Medical Materiel Development Activity's Neurotrauma and Psychological Health Project Management Office has signed an agreement with the Department of Veterans Affairs Cooperative Studies Program that will help guide the studies, which could begin in about a year.


"Clinical studies at locations across the U.S. will take an additional 24 to 36 months to complete, according to Maj. Gary Wynn of USAMMDA, which is based at Fort Detrick.


"We're not just looking to do a study, we're looking to do a program," Wynn said.


"Wynn, a research psychiatrist who also works at Walter Reed National Military Medical Center in Bethesda, is chairing the effort for the Department of Defense.


"The goal is to identify drugs already on the market that may help in treating PTSD and seek U.S. Food and Drug Administration approval for their specific use in treating the disorder, Wynn said. In some cases, health care providers may already be using certain drugs off-label to help, Wynn said, but they are not approved for use.


"Providers have found certain drugs help aspects of (PTSD), but nothing has been studied to the FDA level," Wynn said.


"Only two drugs, paxotene, known as Paxil, and Zoloft, are approved for the treatment of PTSD, Wynn said.


"The disorder's symptoms include flashbacks, loss of sleep and nightmares. Its cause is unknown, according to the National Institutes of Health.


"Studies have shown that 10 to 15 percent of soldiers who deploy in a given year may develop PTSD, Wynn said.


"Researchers are eyeing 10 to 20 drugs that might be helpful for treatment, Wynn said, including Seroquel, an antipsychotic, and Lunesta, which is used to treat insomnia." here

This announcement comes less than three months after the Army Surgeon General and Army Medical Command warned doctors against using psychotropic drugs for PTSD; citing fatal risks and lack of efficacy.

The question is why is the DoD and the Department of Veterans Affairs partnering to study drugs that are known to have fatal risks when it is known the drugs are not effective treatment for PTSD? The answer is given by Major Gary Wynn; a psychiatrist, who reports the purpose of the drug trials will be to, "seek U.S. Food and Drug Administration approval for their specific use in treating" PTSD.  This is not a valid ethical purpose for conducting a drug trial using human subjects. It is what is referred to as a 'seeding trial,' the primary purpose of which is to expand the market for a particular drug; or in this case, multiple drugs.  Why is the US Government planning on conducting and paying for research which is obviously unethical, and plainly nothing more than a part of the pharmaceutical industry's drug marketing strategy?

Why is the DoD and Veterans Affairs not announcing that it is going to make it a priority to fund the type of treatment that has empirical evidence of being effective for treating PTSD?  Apparently, ensuring that the military continues to be a source of revenue long term for the pharmaceutical industry takes precedence over providing effective non-lethal treatment for our troops with Post Traumatic Stress Disorder.

Major Gary Wynn is a psychiatrist and is going to head this project.  Since the drugs are already known to be ineffective, and multiple warnings have been issued cautioning against using them to treat PTSD due to risk of fatality and the drugs inefficacy; it is a violation of the ethical guidelines of the medical profession, to even prescribe them for PTSD. "First, do no harm..." These drug trials are not for the primary benefit of the troops who have PTSD. It is obvious that the preservation and defense of the individual rights; i.e. Constitutional Rights, of the troops who will be used as research fodder in what is clearly Human Experimentation is not even a concern; it's morally reprehensible. 

last month in Navy Times:
DoD cracks down on off-label drug use

"The message from Air Force Lt. Gen. Brooks Bash informed White that U.S. Central Command had decided in March to remove the powerful antipsychotic drug Seroquel from its approved formulary list." here


via Air Force Times: 
Army launches study of PTSD meds

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." here

via NextGov Broken Warriors April 25, 2012:

ARMY WARNS DOCTORS AGAINST USING CERTAIN DRUGS IN PTSD TREATMENT


"The Army Surgeon General's office is backing away from its long-standing endorsement of prescribing troops multiple highly addictive psychotropic drugs for the treatment of post-traumatic stress disorder and early this month warned regional medical commanders against using tranquilizers such as Xanax and Valium to treat PTSD.

An April 10 policy memo that the Army Medical Command released regarding the diagnosis and treatment of PTSD said a class of drugs known as benzodiazepines, which include Xanax and Valium, could intensify rather than reduce combat stress symptoms and lead to addiction.

The memo, signed by Herbert Coley, civilian chief of staff of the Army Medical Command, also cautioned service clinicians against prescribing second-generation antipsychotic drugs, such as Seroquel and Risperidone, to combat PTSD. The drugs originally were developed to treat severe mental conditions such as schizophrenia and bipolar disorder. The memo questioned the efficacy of this drug class in PTSD treatment and cautioned against their use due to potential long-term health effects, which include heart disorders, muscle spasms and weight gain."  read here

via NextGov Broken Warriors August 2011: 

VA SPENT $717 MILLION ON A DRUG DEEMED AS EFFECTIVE AS A PLACEBO

"Over the past decade, the Veterans Affairs Department spent $717 million for an anti-psychotic drug to treat post-traumatic stress disorder that a recent study shows is no more effective than a placebo."

"While the paper on risperidone published earlier this month reported the results of the first large trial measuring the effectiveness of second-generation anti-psychotics in the treatment of PTSD, previous research found little evidence the drugs were effective and VA's own clinical practice guidelines, first published in 2004, when the department spent $66 million on risperidone and $56 million on Seroquel, warned against using the drugs to treat PTSD." here


In 2011 it was announced that Venlafaxine became a "First- Line Treatment" for PTSD even though it is not FDA approved to treat PTSD.

via Clinical Psychiatry News 3-11-11
Venlafaxine Becomes First-Line PTSD Therapy in Latest VA Guidelines


"The new Veterans Affairs/Department of Defense (VA/DoD) evidence-based guidelines strongly recommend that all adults with PTSD be offered pharmacotherapy with a first-line agent. That means either an SSRI, for which the strongest evidence of benefit exists for sertraline, paroxetine, and fluoxetine, or a serotonin norepinephrine reuptake inhibitor (SNRI), among which venlafaxine has the strongest supporting evidence, said Dr. Villarreal, a psychiatrist at the University of New Mexico, Albuquerque, and the New Mexico VA Health Care System." here

The Entire Broken Warriors Series from NextGov

Soldiers who have committed suicide / homicide while on psychiatric drugs

mental illness is like any other illness? not in my family's American experience

I have wondered for years, why are reports and data from research paid for with Government Grants, is not readily accessible to the American people,  Is it because it is more difficult to defraud people when you put the actual information in front of them; not just the biased press releases and public service announcements developed by marketing departments?  Journalists, at one time used to independently verify information before "going with the story;" reporting the news.  There are studies conducted paid for by NIMH, and not published in this country.  How often is this happening?  It is not unusual, I have found.  In effect, the American people pay for research, and do not have ready access to the results.

Most of the research that is published here in the US is published in 'peer-reviewed' professional journals that restrict access.  Yet, we are expected to accept that the research was done correctly and ethically, our acceptance is to be based solely on a report, not the data itself. (reports can be biased and offered by someone with a Conflict of Interest)   Propaganda passes for news and press releases from marketing departments for 'news in the public interest.'  Major media news outlets use these press releases as 'news.' News can be reported along with a heavy dose of direct-to-consumer advertising for a product that is in the news. Biased reporting of medical studies being presented alongside copious direct to consumer marketing results in a seriously misinformed populace. Seems to me, it would increase the risk for harm.

It is a free country and any one who chooses to take the willfully blind and/or ignorant route is free to do so.  I am not one of them, and I am so totally outraged by how my family has been treated by people who are public servants and public employees, theoretically, working for us, but acting against us illegally at times, actually committing Federal Crimes, violating our civil rights.  Some public servants have committed perjury in Courts of Law, and retired with pensions.  These crimes were reported; and covered up,instead of being investigated or prosecuted.   I have been slandered and maligned by some of these people; so has my son.  In vain, I have desperately sought Justice for my youngest son; fought for my Constitutional Rights as a parent, and for my son's Human Rights as a trauma victim since 1993.  I have been treated with disrespect by public servants who have abused their authority and power people who have committed the felony crimes of perjury, forgery, Medicaid fraud. The worst of all, were those who medically neglected, tortured and physically abused my traumatized son, with impunity.  These events traumatized all of us--and disabled my brilliant son.

Jon McClellan, psychiatrist, "Quack Master Jack,"  i.e. the thug in a white coat who drugged my kid into a state of disability without Consent (Informed or otherwise).  He repeatedly told me I had NO SAY.  Quack Master Jack gets 1.8 million dollars bi-annually from the State of Washington.  I asked my State Senator and both State Representatives, to help me.  I have been given the silent treatment.  Good ol' boys, that I actually voted for.  I asked them to look into this knowing it is germane, I know that my concerns are valid.  The State of Washington's foster children, kids in treatment, in group homes and correctional facilities are not protected from the risks of the kind of iatrogenic harm that disabled my son.

Is it not a priority to protect children who are in the State's custody?

One of them the two representatives actually asked what I wanted him to do?!  I suggested he represent his constituents, namely my son, and myself.  I then suggested perhaps maybe the kids in state custody, even though they don't vote yet; are in need of his representation.  There are 47 children in Child Study and Treatment Center, consistently, at least 50 %, if not more are in fact Wards of the Court. Kids who do not have families involved to offer support, or Informed Consent.

My son spent more than 5 out of 10 years of his childhood in this facility.    He was "traumatized over and over and over;" it was none too easy on his brother and myself, I assure you.  He asked me in agony, "how could they take so much from me mom?"  I have no answer.  I know I will remember the sound of my child's terror-filled pleas echo in my memory for the rest of my life.  I know I tried to stop that prick.  I know I can not do anything to change what happened.  I know I have a duty to do whatever is in my power to stop it from happening to anybody else.

Kids who don't yet know that they have Constitutional Rights and that if these Rights are not defended, there is no equal protection under the law.  I bet a lot of those kids know they are not "protected."  I can't forget.

In Washington State, adolescents at the age of thirteen have the legal right to give consent for mental health services and substance abuse treatment.  Parental permission or consent is not required.  This law was passed to enable kids who have a desire to get help, who do not have their parent's support to get the help they need.  This law is in fact being used to exclude parents---in effect, denying parental rights to make medical decisions,  for their children.  This is happening in families who are not involved in "the system."   Reading the law it is clear to me that while it gives minors the right to consent to treatment--it does not diminish, or imply that a parent's Constitutional Rights are as a result diminished.

What is happening in real life is professionals are telling kids, "your parents do not need to be involved at all--we don't need them here.  You are old enough to make these choices for yourself."  In reality, an intelligent mature adult would have difficulty; since in order to provide Informed Consent, one needs to be given accurate unbiased information, and make a decision without being coerced.  Unless it is an emergency, a person is to have an opportunity to consult with others before receiving the prescribed "treatment" (drug or drugs)  Much of what is known about the drugs used for emotional and behavioral symptoms is based on a tainted and biased evidence base.  Rampant fraud and corruption in the FDA approval process and in the marketing of psychiatric drugs, puts everyone at risk.  It is obvious this law places children at risk. How many thirteen to eighteen year olds would know what kind of questions to ask about possible risks, potential benefits, and ask if there is anything besides drugs to help them? (that won't possibly cause dangerous negative effects, possibly disable them and/or cause their untimely death?) 


In the FDA AERs database, #574579 is Rebecca Riley, there is another 4 year old's death listed in 2007 from Seroquel--no gender is  listed and that is more that a little sad. A child who is reduced to a nameless, faceless statistic...I wonder did anyone cry over that child's death besides me?

How many kids (or parents) are actually told of the risk of fatality or heart damage from the drugs used to "treat" ADHD?  Are they told the drugs are in fact addictive, and that some have the same effect on the brain as illicit drugs?  Antipsychotics are being used for behavior control, for "bipolar" the most recent diagnosis de jour.  They are addictive, potentially disabling, and/or fatal; used as directed---even when the drugs appear to be 'helping' and are perceived as beneficial by the person taking them, used long term can cause serious iatrogenic diseases and brain damage.  I know this NOT because any psychiatrist or other mental health professional ever told me, but, because I made it my business to start researching when Quack Master Jack's behavior caused me to mistrust him.

Deceptive practices allow psychiatry and pharma to continue to do a smoke and mirrors snake oil medicine show with our psyches, our tax dollars, our Police, our Courts, AND our fundamental freedoms; our Human Rights.  Fraud, corruption and Human Rights crimes committed against individuals who are given a diagnosis. When diagnoses are adjudicated in Courts of Law, court procedures do not adhere to the same standards appplicable in any other court proceeding.  Civil Commitment laws virtually eviscerate the Rules of Evidence standard. The reason this is done is because diagnostic criteria and treatment standards rely on subjective opinions and are Standardized for clinical use by a quasi-democratic process. It is impossible to submit evidence in compliance with the Rules of Evidence that any psychiatric diagnosis is caused by a disease---such an attestation could not be supported with scientific evidence in compliance with the Rules of Evidence.

The treatment can be disabling or lethal...no biggie...at all.

NAMI says 'mental illness is like any other illness' 

A teacher in grade-school taught me about the Constitution of the United States of America. This document is gospel.  It is The American Gospel; it is why people seek refuge, and their own American dream here more than two hundred years after The Constitution was written.  I wonder... when I am once again struck by the injustice, the utter disregard for the law, and the manner in which our individual rights were neither preserved, nor defended; I (still) wonder, if I am naive?

I do not believe so.  I am grievously disappointed in my fellow man, and in My Country.  My sons and I are not victims; we are survivors.  The Constitution of the United States of America is Our American Gospel.  We know there just aren't enough people who understand exactly what is at stake.  We have elected representatives, and paid public servants who swear solemn oaths, yet fail to fufill their sworn duties.

It is a failure that has altered the course of my family's American experience.

"Whenever a doctor cannot do good, he must be kept from doing harm." 
Hippocrates


“Justice without force is powerless; force without justice is tyrannical.”  

Blaise Pascal

"Watch out for people who begin with another's concern to end with their own." 

Balthasar Gracian

"God grant me the courage not to give up what I think is right 
even though I think it is hopeless."

Chester W. Nimitz

The bible verse associated with my name

My Dad's Army Air Corps Unit's Motto

"Sustineo Alas" translation: "I sustain the wings"  

portions of this were first posted February 2011