What's missing in the Psychiatric Times Article, "Prescribing Psychotropics for Women of Childbearing Potential"?

me and my grandson, Ragnar

I believe disclosures should be at the beginning of any professional journal article. ( particularly in journals and on websites that are basically marketing endeavors operating under the guise of providing continuing education to medical professionals by publishing professional journal articles)

via Psychiatric Times:

Prescribing Psychotropics for Women of Childbearing Potential

March 14, 2014 | Psychopharmacology, Mood Disorders
By Marlene P. Freeman, MD

DISCLOSURES
Dr Freeman is Associate Professor of Psychiatry at the Harvard Medical School; Medical Director, Clinical Trials Network and Institute; and Director of Clinical Services, Perinatal and Reproductive Psychiatry Program at the Massachusetts General Hospital in Boston. She has received research support from GSK and Lilly; is on the advisory boards of Lundbeck, Taleeda, Otsuka, and Genentech; and does medical editing for DSM Nutritional Products. (emphasis mine)

an excerpt:

"For some medications, such as SSRIs, lamotrigine, and benzodiazepines, there are a great number of published studies—some with conflicting results.7 For other medications that are known teratogens, such as lithium and valproic acid, the association with birth defects is clear, but the absolute risk of teratogenicity must be understood to make informed decisions.7 With lithium, which has a known association with a specific cardiovascular malformation—Ebstein anomaly—the absolute risk is low. Approximately 0.1% to 0.2% of pregnancies are affected when there is exposure in the first trimester. In contrast, valproate has a known and common association with neural tube defect, estimated to occur in 1% to 5% of exposed pregnancies.7 "  

Dr. Freeman's article does not even mention neuroleptic drugs, called antipsychotics, which are direct to consumer marketed in the United States as adjunct treatment for mood disorders; this may have been an oversight. It appears to reflect a head in the sand approach to the elephant in the room. Some of Dr. Freeman's statements that appear to undermine FDA warnings about the teratogenicity of FDA approved drugs is, in effect, basically a declaration that the elephant the good doctor is pretending no one sees can't possibly be dangerous; if it is, the elephant is not as dangerous some know it is. 

I don't tend to put much stock in doctors who fail to communicate in a forthright manner. Perhaps I am being harsh, but I don't believe so. A doctors stock in trade is a patient's perception of the doctor, and the real world effect on the patient (from the patient's perspective). It is important for a doctor to be HONEST. Psychiatrists cannot mislead through use of analogies and myths to explain psychiatric diagnoses are "real diseases"; label people who don't trust them with anosognosia, having no respect for authority, paranoid or delusional while simultaneously endorsing forced treatment under color of law on unwilling patients. Involuntary treatment is justified solely by professional opinion. In effect, by stating the person has a psychiatric diagnosis and that it is a "medical necessity" the person must have psychiatric treatment. The Rules of Evidence are not required or followed in the civil commitment process in Washington State. No evidence of the "medical necessity" of psychiatric treatment, no evidence that a patient has an identifiable neurobiological condition or a brain disease; and worse, no evidence that psychiatric treatment will benefit the patient forced under color of law is even required. 

Whether a patient believes a professional is communicating honestly with them, is perceived to have a genuine kind regard for them, and has the ability to treat a patient ethically, is not as important as the psychiatrist being humble and honest enough to practice medicine with ethical integrity. A doctor's primary duty ethical duty is to the patient; regardless of a psychiatrist's biases and beliefs about what causes "mental illnesses," and how to best help the people who are believed to have a psychiatric diagnosis. While it is unfortunate and "challenging to remain apprised of data pertaining to medication use in pregnancy, since the literature is constantly evolving;" it is more unfortunate that there has been so little evidence offered to validate or support psychiatric diagnoses and treatment. 

Why are psychiatrists emotionally defending psychiatric diagnoses and the psychotropic drug treatment regimens that purportedly medically treat them?  Ethical integrity demands psychiatric diagnoses and drug treatment algorithms be empirically validated and supported; not merely believed in and relied upon by consensus. In effect, psychiatry has developed standards of care that protect psychiatrists from being held legally liable for iatrogenic harm caused to patients. The purpose of treatment standards is to protect patients from unethical medical practitioners; why are treatment standards used to refute accusations of iatrogenic harm? Psychiatry's treatment standards serve as a protective legal shield for psychiatrists professionals who wield Police Powers to detain and involuntarily treat patients with drugs  and/or electroshock treatments with serious risks including permanent disability and death. Since psychiatrists are doctors we must believe they are honest, ethical and NO EVIDENCE IS REQUIRED.

via Canadian Pediatric Society:

Selective serotonin reuptake inhibitors in pregnancy and infant outcomes

Principal author(s)Ann L Jefferies; Canadian Paediatric Society, Fetus and Newborn Committee
Abridged version: Abridged version: Paediatr Child Health 2011;16(9):562

Abstract

Adequate treatment of depression during pregnancy is very important for maternal, fetal and neonatal health. Selective serotonin reuptake inhibitors (SSRIs) are commonly used antidepressants. According to one American study, approximately 7% of pregnant women were prescribed an SSRI in 2004-2005. First trimester use of SSRIs, as a group, is unlikely to increase the risk of congenital malformations. Paroxetine may be associated with a small increased risk of cardiac malformations, but evidence remains inconclusive. Fetal exposure to SSRIs closer to time of birth may result in respiratory, motor, central nervous system and gastrointestinal symptoms in about 10% to 30% of newborns (SSRI neonatal behavioural syndrome). These symptoms are usually mild and transient. Persistent pulmonary hypertension of the newborn is an extremely rare consequence of fetal exposure. This information should be used to make individual risk-benefit decisions when considering the treatment of depression during pregnancy. Newborns with late- pregnancy exposure to SSRIs should be observed in hospital for at least 48 h. read here

Recovery and Psychiatry: Dirk Corstens, Chair of Intervoice responds to Allen Frances

@yobluemama2 I do support Intervoice but also support meds when needed. Complementary-no one right way http://t.co/I5HBJIoZVZ
— Allen Frances (@AllenFrancesMD) September 16, 2013

Allen Frances responded to the open letter by writing, "Reconciling Recovery and Psychiatry: Response to Open Letter" for his blog in Psychology Today.  I find Allen Frances' criticism of those harmed by psychiatry insulting; frankly, I find his professional posturing in this instance, resembles juvenile bullying. Frances claims his criticism is motivated by concern for people with psychiatric diagnoses; apparently, he is afraid people may believe and be inspired by the hearing voices movement. Why is the idea that people with a diagnosis of schizophrenia may feel hopeful for recovery is something to fear? Frances states he is concerned that "trying to follow Ms Longdon's path might help some, but may harm others." 

I, on the other hand, am concerned that Frances did not "cover the waterfront of possibilities" accurately or ethically in his response. The hearing voices method, "could not possibly serve as a model for everyone who hears voices," so Frances claims he wants to prevent people from thinking Eleanor Longden's personal story is "a blanket condemnation of all psychiatric treatment"?!  I'm skeptical of the veracity of this claim since Frances is promoting the medical model as "essential," while decrying the harm done by "Big Pharma and the physicians who over prescribe."  My skepticism arises from Allen Frances's failure to disclose his collaboration with Big Pharma, the widely disseminated Expert Consensus Guidelines; which are still marketed as treatment standards meant to inform pediatricians, GPs, Internists, etc. to guide how they treat people using current psychiatric standards of care.  There's no concern about patients being disabled and killed as a direct result of being diagnosed and treated according to a consensus of expert opinions...

Doctors rely on guidelines to inform treatment decisions believing the guidelines are based on valid evidence of treatment safety and effectiveness; not a drug marketing strategy! 

I want to share the comment left by psychiatrist, Dirk Corstens, the Chair of Intervoice, in response to Allen Frances's blog post answering Intervoice's Open Letter:

Recovery and Psychiatry
Submitted by Dirk Corstens on September 17, 2013 - 12:41am.


Dear Professor Frances,

Thank you for your prompt response to the open letter sent to you from Intervoice. I would like to take this opportunity to continue the dialogue by offering some of my own reflections on your recent article.

You reiterate that people diagnosed with schizophrenia need medication, because you witnessed "dozens of lives ruined" by people coming off it. That is what I also learned during my psychiatric training, something that was systematically confirmed by colleagues. Proceeding with that mind-set, I also saw dozens of people struggling to come off medication, often unsuccessfully - but mostly due to lack of support (e.g., "when you don't take your medication we stop treatment").

After more than 25 years of experience working in clinical and social psychiatry, much reading, and much meeting and collaborating with many voice hearers, like Eleanor, who bravely took their own roads to recovery, I have definitively changed my mind and practice.

My present mind-set - my most accurate and honest conclusion about psychosis and medication - is that I really don't know who needs medication and who does not. I now believe it is better to prevent prescribing medication whenever possible.
Modern psychiatric practice tends to endorse that people with psychotic experiences - or what psychiatrists believe are psychotic experiences - rarely get access to psychological therapies, and almost never as a first-response treatment (despite robust evidence that it works). Without much communication, and almost automatically, antipsychotics are prescribed. As you may know, in some European countries young patients are even prescribed three different medications at a time. Modern psychiatric practice is ruled by a fundamental fear of psychotic experiences and the objectively false premise that antipsychotics eliminate it. There is abundant reason to change this mind-set: communicate, care, and support. Wait, create a safe environment. Wait and listen. Try to make sense of experiences. Only prescribe low doses when necessary and stop when possible.

The most important reasons:
- The diagnosis of schizophrenia is scientifically unreliable (see for example Richard Bentall and Mary Boyle - not anti-psychiatrists, but research-psychologists who think in a scientific way) and more stigmatising than helpful. And of course, there are no specific symptoms nor tests that confirm if the diagnosis is accurate or not.
- It is more and more uncertain that antipsychotics improve the long-term prognosis of psychosis. Many colleagues now state that the prognosis is not better or worse than before chlorpromazine was administered to patients. Functional recovery seems better when people don't take antipsychotics or only in low doses (e.g., Harrow, Wunderink, Mosher, Ciompi).
- There is good reason to believe that antipsychotics often do more harm than good (e.g., Breggin, Whitaker, Healy, Moncrieff, Lehmann).
- There are a lot of promising alternatives: Open Dialogue, Soteria, CBT, psychosocial therapies, hearing voices networks, self-help groups, trauma-informed therapies. These alternatives have existed a long time; are well documented; propagate the cautious and sparse use of medication - and give good results.
- More and more people who utilise psychiatric services openly state that they prefer a personal approach and need a say in their treatment and choice.
It is really exciting and rewarding to operate as a psychiatrist from this alternative mind-set with people who report subjective experiences that overwhelm them.

Eleanor's story tells us professionals that meeting the person behind the symptoms, communicating about the real personal story, creating a safe environment, and supporting family members and other allies are the most fundamental ingredients of good psychiatric care and cure. She didn't say what other people should do or not. It is not a story about medication at all - she only tells it didn't help her, and after taking it for a while came off it. It is a story of struggle and hope. A real and personal story.

I really don't understand why you feel the need to censor her.

Dirk Corstens, consultant psychiatrist
Chair of Intervoice
www.intervoiceonline.org

photo credit here

PHARMABATE: Ethics and Transparency in the Pharmaceutical Industry

PHARMABATE from Barry Durkin on Vimeo.
hat tip: pharmagossip

Almost 2 million Americans are addicted to prescription opiates; addiction is not rare

Washington Post

There is no justification for corrupting the medical evidence base, 

undermining the ethical integrity of the medical profession, 

and causing the deaths of countless patients.

There are only excuses like this one:

“Because the primary goal was to destigmatize [opioids], 

we often left evidence behind." Dr. Russell Portenoy

The primary goal of medicine is to ethically treat patients, 
using sound medical judgement.  

Sound judgement requires careful consideration of all the available evidence. 

via The Alliance for Human Research Protection:

Rising Painkiller Addiction Shows Damage From Drugmakers’ Role in Shaping Medical Opinion

Tuesday, 01 January 2013
“You could say these marketing tactics are merely concerning. But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives,” said Phillip Prior, MD

"Below is the latest in the Washington Post series--Can Medical Research be Trusted? its focus is the continued rise in painkiller addiction and the decisive role played by corrupt pharmaceutical marketing practices.

"Of note, more than a decade ago, in 2002, the US Drug Enforcement Administration (DEA) reviewed medical examiners' toxicology reports from 32 states. The DEA reported that OxyContin was involved in 464 overdose deaths, few included alcohol consumption.

"But, over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients. The label on the drug, which was approved by the FDA, said the risks of addiction were “reported to be small.”The New England Journal of Medicine, the nation’s premier medical publication, informed readers that studies indicated that such painkillers pose “a minimal risk of addiction.” Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.

"Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast.

"The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics.

“Around here, we call it ‘pharmageddon,’ ” said Lisa Roberts, the public health nurse for the town, whose primary job is to reduce the fatalities associated with drug use. “This has been absolutely devastating to Appalachia. From what we’ve seen, the risks of addiction were tremendous.”

· “It turns out that the doctors didn’t know what they were talking about,” said Barbara Howard, whose daughter Leslie, a home-care nurse, died of an overdose in 2009 in this small Appalachian town devastated by the epidemic. She had developed a habit after knee surgery. She left behind a 9-year-old son.

· “Leslie trusted the doctors. We thought the doctors knew what was best. But they didn’t. We — and lots of the other victims — had no warning.”

“You could say these marketing tactics are merely concerning. But I think of them as satanic. What the data are telling us is that these drugs are ruining people’s lives,” said Phillip Prior, MD

"To refine its policy on opioids, the FDA convened a key meeting in 2002 and invited 10 outside experts for advice. Five of them reported having served as speakers or investigators for Purdue. Three others reported working as speakers for or as advisers and consultants to other pharmaceutical companies.

"One of those FDA advisers, Dr. Russell Portenoy, who was then the chair of the Department of Pain Medicine and Palliative Care at the Beth Israel Medical Center in New York, has since expressed regret for his evangelism on behalf of opioids.

"He was “trying to create a narrative so that the primary care audience would . . . feel more comfortable about opioids,” Portenoy said in a 2010 interview, “Because the primary goal was to destigmatize [opioids], we often left evidence behind. (emphasis mine)

“To the extent that some of the adverse outcomes now are as bad as they have become in terms of endemic occurrences of addiction and unintentional overdose deaths, it’s quite scary to think about how the growth in that prescribing driven by people like me led in part to that occurring.”

"In 2003, Purdue Pharmaceuticals, the manufacturer of OxiContin--whose sales reached $1.3 billion--had the gall to sponsor advertisements warning about prescription drug abuse!

Vera Sharav here

By Peter Whoriskey,

Rising painkiller addiction shows damage from drugmakers’ role in shaping medical opinion

  December 30, 2012    

"Portsmouth, Ohio — Over much of the past decade, the official word on OxyContin was that it rarely posed problems of addiction for patients.

"The label on the drug, which was approved by the FDA, said the risks of addiction were “reported to be small.”

"The New England Journal of Medicine, the nation’s premier medical publication, informed readers that studies indicated that such painkillers pose “a minimal risk of addiction.”

"Another important journal study, which the manufacturer of OxyContin reprinted 10,000 times, indicated that in a trial of arthritis patients, only a handful showed withdrawal symptoms.

"Those reassuring claims, which became part of a scientific consensus, have been quietly dropped or called into question in recent years, as many in the medical profession rediscovered the destructive power of opiates. But the damage arising from those misconceptions may have been vast. 

"The nation is confronting an ongoing epidemic of addiction to prescription painkillers — more widespread than cocaine or heroin — that has left nearly 2 million in its grip, according to federal statistics." read here

The Rise and Fall of Atypical Antipsychotics: The belief in pharmaceutical marketing messages

 

via BJPsych:

Editorial

The rise and fall of the atypical antipsychotics

TIM KENDALL

Declaration of interests:
T.K. receives about £1.4 million per year from the National Institute for Health and Clinical Excellence (NICE) to develop clinical practice guidelines for the National Health Service in England and Wales. He also receives funding/grants from other bodies including the Academy of Medical Royal Colleges, the Department of Health and NICE International to undertake systematic reviews or guideline development. T.K. is a co-opted member of the Council of the Royal College of Psychiatrists and contributed to the development of the College Report CR148 on psychiatrists’ relationship with the pharmaceutical industry

the final two paragraphs:

In the recently updated NICE schizophrenia guideline we also found that there were no consistent differences between atypicals and typicals, SGAs and FGAs; there were no important differences between any of the antipsychotics in terms of clinical or cost effectiveness (except for clozapine in treatment-resistant schizophrenia); the side-effects varied from drug to drug and were not determined by class; and all the antipsychotics were associated with potentially serious dose-related and other side-effects. 4 Although some of the newer drugs are associated with lower rates of EPS/tardive dyskinesia, they are also linked to different and equally severe side-effects such as diabetes, and some other newer drugs may have similar rates of EPS to the older drugs. From Girgis et al in this issue, it now seems unlikely that there are any longerterm benefits for using atypicals or SGAs in the first episode.

In creating successive new classes of antipsychotics over the years, the industry has helped develop a broader range of different drugs with different side-effect profiles and potencies, and possibly an increased chance of finding a drug to suit each of our patients. 4 But the price of doing this has been considerable – in 2003 the cost of antipsychotics in the USA equalled the cost of paying all their psychiatrists. The story of the atypicals and the SGAs is not the story of clinical discovery and progress; it is the story of fabricated classes, money and marketing. The study published today is a small but important piece of the jigsaw completing a picture that undermines any clinical or scientific confidence in these classes. With the industry reputation damaged by evidence of selective publishing and its deleterious effects, 15,16 and the recent claims that trials of at least one of the new atypicals have been knowingly ‘buried’, 2 it will take a great deal for psychiatrists to be persuaded that the next new discovery of a drug or a class will be anything more than a cynical tactic to generate profit. In the meantime, perhaps we can drop the atypical, second-generation, brand new and very expensive labels: they are all just plain antipsychotics. here

As interesting as the above article is, I found what the editor of the British Journal of Psychiatry, Peter Tyrer said about the SGAs interesting, and the response to Tim Kendall's editorial from The Last Psychiatrist, illuminating.

From the Editor's desk

1. Peter Tyrer

Spotlight on antipsychotics

The act of prescribing an antipsychotic drug in psychiatry is like sex; it is almost universal in practice yet indiscriminate use can lead to multiple pathologies. Where it differs from sex is that the act is almost completely devoid of pleasure for most parties involved. Patients tend to hate these drugs because of their panoply of adverse effects – not for nothing was chlorpromazine named Largactil – and practitioners, unless they are avid psychopharma- cologists, feel their prescription is a necessary evil that is likely to change the relationship with their patients from a cooperative to a coercive one, particularly in a hospital environment.^1,2 We would all feel a lot better if this range of drugs was replaced by one that was at least equally effective and did not have the potential to attack every organ system in the body when it wasn’t looking, or even looked for, in clinical and research practice.³ Six papers in this issue touch on this subject from different angles. After looking at the similarities between the long-term benefits of clozapine and chlorpromazine in schizophrenia (Girgis et al, pp. 281–288), Kendall (pp.266–268) goes for the full frontal assault on the way guidance has been distorted by the pharmaceutical industry, ‘a story of fabricated classes, money and marketing’, with most changes being no more ‘than a cynical tactic to generate profit’. I have to declare my own interest here; I cannot see any justification for separating first- and second-generation antipsychotics and think these terms should be dropped far, far away from rediscovery by gullible psychiatrists.⁴ But Leucht & Davis (pp. 269–271) rightly emphasise the variability of antipsychotic drugs and that prescription should follow a ‘shared decision-making process’ with the patient, provided, some would add, that this is an honest and genuine one.⁵ Frighi et al (pp. 289–295) show that in those with intellectual disability, adverse effects are not usually major. My own explanation of this somewhat surprising finding is that because shared decision-making is much more difficult with this group than with those of normal IQ and that a minority of patients is unduly sensitive to these drugs, much lower doses are prescribed than in others and so there are fewer adverse consequences. Suzuki et al (pp. 275–280) confirm my own impressions from clinical practice that if there is no clinical response to an antipsychotic drug fairly soon after prescription (within 6 weeks) then its further prescription should be questioned, and long-term usage regarded as rare. (emphasis mine) here

via The Last Psychiatrist:
The Rise And Fall Of Atypical Antipsychotics [sic]

His point is that the atypicals aren't really better than the typicals (duh.)  Of course he's right, but in being factually accurate he is being deliberately deceitful.  

To be clear: I am obviously aware of the buried data and the obfuscatory shell games of Big Pharma, but the truth of these medications has been available even without resorting to studies no one would have read anyway.  But in order to hide the fact that no one really paid much attention to the actual data that was in front of them (they took the word of the local thought leader and figured that was that) they pretend that the problem is the buried data. (empasis mine) here

photo credit

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...

Conflicts of Interest: Washington State's mental health planning and advisory council

Photo Credit: bobverill

HISTORY AND PURPOSE OF PLANNING COUNCILS

These federal laws require states and territories to perform mental health planning in order to receive federal Community Mental Health Services Block Grant funds.

These laws further require that stakeholders, including mental health consumers, their family members, and parents of children with serious emotional or behavioral disturbances must be involved in these planning efforts through membership in the Council. here  

Consumers, family members, parents of children worth serious emotional or behavioral disturbances are supposed to comprise half the membership on planning councils... There are 39 members and the vast majority of them are State employees, some are mental health service providers with a major conflict of interest--they make their living by billing Medicaid for mental health services provided to people on Medicaid.  Eleanor Owen,  represents NAMI Seattle and is a founding member of NAMI Washington. NAMI affiliates throughout Washington receive State, Federal, County and grants as well as being funded and advised by the pharmeceutical industry. 

1. Annabelle Payne Community Member 3/1/2015 Director and County Coordinator at Pend Orrielle County Counseling Services  

2. Armando Herrera Community Member 3/1/2015

3. Becky Bates Community Member 3/1/2014 Director of Passages part of Volunteers of America in Spokane

4. Carolyn Cox Community Member 3/1/2015 The Family Support Coordinator for Three River's Wraparound program with Lutheran Social Services and a contracted provider for Medicaid Mental Health Services for Benton/Franklin Human Services.

5. Carrie Huie-Pascua Community Member 3/1/2014 Was hired by Yakima County as the Director of Yakima Valley Systems of Care a SAMHSA Children's Mental Health Initiative grant project. Her job prior to this was the director of Benton-Franklin Department of Human Services. Immediately after quitting this job, she was appointed to be the consumer advocate representing Yakima County on this planning council. However, prior to her job with Benton/Franklin Human Services, she was Clinical Director at Nueva Esperanza one of the community providers for mental health services that Benton/Franklin Human Services contracts with. This agency had repeated irregularities with annual audits; in fact the agency was found to have committed fraud in the amount of $500,000 in  one 'irregularity.' The thing is, there is no way that Ms. Huie-Pascua could not have known about the 'irregularities' while employed as the Clinical Director at Nueva Esperanza.  The inappropriate billing went on for a while. As the director of Human Services for Benton/Franklin Counties, she was responsible for holding her former employer accountable, or at least stop the payments. If she was unaware, her lack of awareness is a strong indication of her unsuitability for being an administrator of a publicly funded program. Ms. Huie-Pascua, ethically speaking, would not be a desirable employee if she had been aware, yet failed to act; or unaware entirely. Both  scenarios could only be attributed to carelessness and/or negligence. In her role as the Director of Human Services, she recommended renewing Benton/Franklin Department of Human Services contract with Neuva Esperanza.  When she was questioned in regards to her ill-advised  recommendation, she claimed to be unaware of any "red flags" which would have prevented her making the recommendation. I don't find her claim credible at all. I'm still trying to figure out how she quit an administrative job unexpectedly, (just when the fraud $$ bomb was exploding) and within a couple weeks started representing Yakima County on a State committee as a consumer representative.  Within a month she was hired by Yakima  County as the director of the Yakima Valley Systems of Care. It seems orchestrated...

6. Cassie Undlin Community Member 3/1/2014 Chief Financial Officer Centers for Medicare and Medicaid Services in 2003 went to work at Tatum LLC in 2008. Hired by Gold Coast April 3, 2012 Ventura County Medi-Cal Managed Care Commission (VCMMCC) dba Gold Coast Health Plan; as of July 23, 2012 still the CEO.

7. Dawn Maloney Community Member 3/1/2015 works at Link, a program of the Toutle River Boys Ranch

8. Dorothy Flaherty Community Member 3/1/2015 Professor At Evergreen State College Social Work Native American Studies

9. Eleanor Owen Community Member 3/1/2014 NAMI Mother  

The picture is from The NAMI National Convention program that took place in Seattle at the end of June.  The reason I'm sharing it because it struck me how much and how little can be conveyed in a few sentences .  It is an announcement that four men have been given  new identities and learned skills which enabled them to do things, "by themselves."  Doing things by themselves doesn't include telling their own stories however...which is strange and disturbing. By the time I read that the audience would get a chance "to dialogue face-to-face" with them, I thought, "not nice at all, they are not an exhibit;" and wondered, "why they weren't important enough to acknowledge their accomplishments using their names?"   

10. Jo Ellen Woodrow Community Member 3/1/2014 Volunteers of America

11. Mary O'Brien Community Member 3/1/2015 Clinical Services manager for Yakima Valley Farm Workers Clinic Behavioral Health A Medicaid contracted provider

13. Phillip Gonzales Community Member 3/1/2014 (DSHS/JRA) Business Analyst at State of Washington

14. Sandy Gregoire Community Member 3/1/2015 Family Support Specialist at OptumHealth a for profit health entity that has the contract with Pierce County RSN

15. Stokely Leggett Community Member 3/1/2014 Works at Twin River Community Facility (DSHS/JRA)

16. Susan Kydd Community Member 3/1/2015 Boeing Employees Credit Union

17. Glen Ludwig Community Member 3/1/2015  

Evidence for the Neurotoxicity of Antipsychotic Drugs

22 State Employees 

Melodie Pazolt DBHR-MH Treatment
Michael Langer DBHR-Prevention/Promotion
Steve Kutz IPAC Tribal Representative
Cindy Robison IPAC Alternate
Mark Freedman Regional Support Network
Jalane Christian-Stoker ACHS Chair
Vacant Division of Vocational Rehabilitation
Marci Arthur Division of Developmental Disabilities
Bianca Stoner Insurance Commissioner's Office
Barb Putnam Children's Administration
Greg Williamson Office of the Superintendent of Public Instruction
Pamala Sacks-Lawlar Division of Juvenile Rehabilitation
Kathy Morgan Division of Home/Community Services
Kathleen Arnold Department of Corrections
Tory Henderson Department of Health
Jeanette Barnes DBHR
Beth Dannhardt CD Residential Services
Tim Smith CD Youth Residential
Heather Maxwell MH Quality Review Team
Anita Gallagher Problem Gambling Provider

"How to Recognize a Bad Psychiatrist"

Dr. David M. Allen's recent blog post entitled, "How to Recognize a Bad Psychiatrist," in Psychology today offers some advice, along with some astute and humorous observations about 'how psychiatry is done' by bad psychiatrists; this and a couple of blunt opinions, make it well worth the read.  I am going to share what he had to say about bp magazine, because in this case, Dr. Allen shared information about the publication, and allows his readers to draw any conclusions.

Via Psychology Today: 

A Matter of Personality

From borderline to narcissism.

by David M. Allen, M.D.

How to Recognize a Bad Psychiatrist

Don’t Count Symptoms That Don’t Count
Published on April 16, 2012 by David M. Allen, M.D. in A Matter of Personality
AN EXCERPT:

I was not able to find much online about the publishers of this magazine, and what I found may be faulty, but apparently the publisher, Green Apple Courage Inc., was founded by one Bill MacPhee, a patient with schizophrenia who was finally stabilized on medication and became productive again.

The primary advertisers for BP Magazine were listed on one web site as "Platinum sponsor Pfizer Inc. and Gold sponsors Bristol-Myers Squibb Company, Otsuka America Pharmaceutical, Inc. National mental health association advertisers include the Child and Adolescent Bipolar Foundation, Depression and Bipolar Support Alliance, Mental Health America and the National Alliance on Mental Illness."

I receive the magazine in the mail for free unsolicited, which usually means a pharmaceutical company is paying for producing a publication and distributing it to psychiatrists like me. Draw your own conclusion about whose interest the magazine might be best serving. (emphasis mine) read here

Washington State NAMI Agenda 2012

“Integrity without knowledge is weak and useless, 

and knowledge without integrity is dangerous and dreadful.”

Samuel Johnson

Washington State Capitol 

via NAMI Washington:

NAMI Washington 2012 legislative agenda

Submitted by editor on Sun, 01/15/2012 - 11:20am

a couple of excerpts:

"Medication access — NAMI Washington opposes any defunding of Medicaid or other state medical prescription benefits, any “generics only” formulary, and any “fail first” requirements in any prescription formulary for people with serious mental illness- especially for atypical antipsychotics. Medications are an important part of the treatment plans for those living with mental illnesses. Taking away access to medications in general or even forcing those who are in recovery with non-generic medications to change to possibly ineffective medication in order to change to a generics only system is dangerous and counterproductive."

Guiding principles

NAMI-WA’s 2012 Legislative positions are guided by the following principles:

• Early intensive care and treatment - including hospitalization in some cases - has proven to reduce long-term illness and disability. It is the best way for the State to reduce its long-term costs for the mental health system and, most importantly, to promote the potential for recovery for as many people as possible. In order to ensure the highest possible quality of service, the State should require programs, treatments and other services to be evidence-based or promising practices."

via Clinical Psychiatry News.com:

Broad Analysis Refuels Debate on Atypicals

a few excerpts:

“The spurious invention of the atypicals can now be regarded as invention only, cleverly manipulated by the drug

industry for marketing purposes and now only being exposed,” Dr. Tyrer and Dr. Kendall wrote. 

“On present evidence from all sources, it is difficult not to conclude that the trials of the second-generation antipsychotics seem to be driven more by marketing strategy than to clarify their role for clinicians and patients.”

The investigators criticized pcriticized previous literature reviews and meta-analyses that compared second- and first-generation antipsychotics, aside from Cochrane Reviews, for not assessing side effects thoroughly, even though they are important criteria in drug choice. 

They also faulted previous attempts at distilling the results of trials for analyzing only one global efficacy outcome, despite claims that the main advantage of second-generation antipsychotics is their broad efficacy spectrum, especially for negative symptoms, depression, and quality of life. read here

It is plain that NAMI Washington's 'medication access policy' contradicts NAMI's 'guiding principle,' which state, 'the State should require programs, treatments and other services to be evidence-based or promising practices.'   Washington State has adopted the same 'first line treatments' used in the State of Texas, using treatment algorithms developed for a marketing program known as TMAP.   TMAP was developed to sell the newer more expensive drugs---not because they were better, but because they made more money for the drug companies and their share holders. TMAP, is nothing more that a fraudulent drug marketing strategy developed to facilitate Medicaid fraud and illegal marketing of psychotropic drugs.  It is not 'evidence-based' or a 'promising practice.'  Washington State's Medicaid formulary for psychiatric drugs is modeled after this corrupt program; and it requires Medicaid providers to prescribe the newest neuroleptic and other psychotropic drugs, which are more expensive, but are not any safer, or more efficacious. 

The decision to have ONLY the newest neuroleptic and other psychotropic drugs listed as 'preferred' was not based on valid empirical evidence; and neither is NAMI Washington's medication access agenda.  It is an agenda that NAMI's primary funding source, the drug industry, will benefit from; while the people of the State of Washington continue to be defrauded through it's publicly funded health care programs...

via Alliance for Human Research Protection:

Rolling Stone - Marketing a Phony "Miracle" Drug

a few excerpts:
"Now mainstream professors at Yale and Harvard are acknowledging the marketing success of antipsychotics are not justified by the evidence. None of the drugs used to treat schizophrenia work very well—and they all produce debilitating irreversible physical and neurological damage. The drugs’ failure is related to the lack of understanding about schizophrenia. Scientists acknowledge, “We actually have a profound ignorance of the specific molecular mechanism of schizophrenia.”

“We tend to think of drugs as solving discrete problems — penicillin to eliminate bacteria, insulin to modify diabetes — but the antipsychotics are shooting at an invisible target. With schizophrenia,” says Dr. William Eaton, chairman of Johns Hopkins, Department of Mental Health, "we don't know what the hell is going on."

"It is well to remember that effective drugs, such as antibiotics, don’t need multi-million marketing campaigns.

Wells sought to understand how, Zyprexa, a drug created to treat schizophrenia—in a very tiny population mostly inhabiting county jails and state prisons—wound up being used on depressed moms and misbehaving kids—and how Eli Lilly turned a flawed and dangerous drug into a $16 billion a year bonanza."

"But when those who conduct the trials sell their professional integrity, signing secret confidentiality agreements which prevent them from publishing the actual research findings; and when influential academics pen their name to industry-sponsored ghostwritten reports in those journals; and when prominent physicians are recruited to promote the drugs as “safe and effective” for unapproved uses--thereby broadening the number of patients exposed to the drugs’ harmful effects; the result is even worse than the deception by the tobacco industry. After all, smokers were not urged to “ask your doctor” if smoking is right for you… Prominent doctors with impressive academic credentials did not serve as paid consultants helping tobacco companies to promote smoking."
"To accomplish the extraordinary marketing feat and generating “irrational exuberance” among clinicians, drug manufacturers took control of the drug testing process—including data analysis, authorship (penned by prominent academic psychiatrists), publication placement in key journals—and key academic psychiatrists were recruited for their professional influence to persuade clinicians and public policy officials that a class of drugs—the new ‘atypical’ antipsychotics—were better and safer than the old drugs, despite evidence contradicting such claims. FDA’s impotence vis-à-vis this powerful industry was accomplished after the Reagan administration made it a policy to gut the FDA: “Simply put, the FDA was no longer in a position to independently evaluate the effectiveness — and risks — of a drug like Zyprexa.”
"It is understandable that well-meaning psychiatrists who treated patients with schizophrenia, sought better treatment without the debilitating side effects of the older drugs which they by then recognized as so painful that patients simply stopped taking them, were excited by the promise of an alternative. However, the marketing hype did not make sense from the very beginning: a top Lilly executive announced that its new schizophrenia drug, Zyprexa, has "the potential to be a billion-dollar-a-year drug." Dr. William Wirshing, a psychiatrist at UCLA, is quoted saying: "I almost pulled off the road and crashed into the side rail." At the time, the entire market for atypical antipsychotics was only $170 million. "How the hell do you make $1 billion? I mean, who are we gonna give it to? It's not like we're making any more schizophrenic brains.

"It would be nine years before a comprehensive government study (CATIE) would reverse many of the claims that surrounded Zyprexa and other atypical antipsychotics, and raise disturbing questions about their risks. And nine years, in the pharmaceutical industry, is a lifetime.

"An influential player missing from the Rolling Stones article, is Steven Hyman MD PhD, the Director of the National Institutes of Mental Health, a leading neuroscientist, and a Harvard Professor whose enthusiastic endorsement of both the SSRI antidepressants and atypical antipsychotics, was expressed in widely publicized 1998 letter to the Director of the Center for Medicaid State Operations at HCFA, in which he expressed concern that the high cost of the atypical antipsychotics might constrain their use:
"‘In some parts of the country, we understand that health care systems will not routinely allow new patients to be started on atypical antipsychotic medications until they have failed a course of the standard (less expensive generic) antipsychotic medications. We see no scientific justification for such a practice and consider it particularly ill advised. . . This is a situation in which HCFA and the NIH institutes working in concert can have a substantial beneficial effect on the health care of the American people.
"But in 2002, Allen Jones, an investigator in the Pennsylvania inspector general's office, became convinced that government officials had been enrolled in marketing the drugs. Jones uncovered evidence showing that TMAP promoters included not only prominent psychiatrists, but government officials who set state mental health policies. These officials served as paid “experts” declaring the new antipsychotics “superior.” Though contradicted by the scientific evidence, their opinions had the mantle of government authority, thus ensuring a market and a continuing flow of sales. 

“Between 2000 and 2004, the deaths of 45 children were linked to the atypicals. Some were strikingly young. An eight-year-old boy died of cardiac arrest. A four-year-old boy died of complications from diabetes. Perhaps most vivid of all was the case of a 15-year-old boy in South Florida referred to by social workers as a "runner," a kid who kept fleeing his exasperated foster parents to return to his birth mother. Admitted to a psychiatric hospital by a judge, the boy was tethered to a chair and pumped full of atypical antipsychotics, presumably to calm him. When his lawyer came to visit him, she found the boy not only sedated, but suffering from another acknowledged side effect of the atypicals: His breasts had become engorged and started to leak milk. The boy was lactating.” (emphasis mine)

“Visiting the most celebrated mental-health centers in the United States, it is hard to conclude that, even after the innovation of the atypicals, the drugs make a decisive difference in care.” It is difficult, therefore, to brush off the profession’s failure to recognize the disparity between clinical evidence and marketing hype as “overbright enthusiasm” or “irrational exuberance” or to accept the excuse offered by prominent psychiatrists such as, Dr. Peter Tyrer, Imperial College in London: “Almost the whole scientific community was conned into thinking — as a consequence of good marketing — that this was a different and better set of drugs. The evidence, as it's all added up, has shown this to be untrue."
"If the whole scientific community was “conned,” they should hand in their license as they do not merit the status of “learned intermediaries.” Furthermore, leading psychiatrists who concealed their significant conflicts of interest, serving as industry’s consultants and promoters, who conducted rigged clinical trials and penned their name to fraudulent reports—reports that have polluted the scientific literature—continue to hold sway as prominent leaders within the profession. Shame on the psychiatric establishment for its failure to say, enough of the lies, enough corruption!

"The devastating consequences of deregulation--which gave free rein to predatory profit seekers—is demonstrated in both, the economic meltdown and the transformation of medicine from its therapeutic mission into an accomplice for Big Pharma. The dire consequences of predatory market manipulation are borne by American consumers and taxpayers.

"TIME Magazine has named 25 People to Blame for the Financial Crisis (24 men and one woman). Who will name the names in the medical community who are to blame for the drug-induced mental health crisis?" read here