Market for schizophrenia drugs may be peanuts, but so is the Risperdal settlement

From Bloomberg.com

J&J Said to Agree to $1 Billion Accord in Risperdal Sales
Johnson & Johnson (JNJ) will pay more than $1 billion to the U.S. and most states to resolve a civil investigation into marketing of the antipsychotic Risperdal, according to people familiar with the matter.

J&J, the world’s largest health products company, reached an agreement last week with the U.S. attorney in Philadelphia, according to the people, who weren’t authorized to speak about the matter. Negotiations over a possible criminal plea are still under way, they said.

The U.S. government has been investigating Risperdal sales practices since 2004, including allegations the company marketed the drug for unapproved uses, J&J has said in Securities and Exchange Commission filings (JNJ). The company said it has been in negotiations with the U.S. to settle the investigation.

Read the rest here.

Ablechild and breaking the monopoly on psychiatric treatment with medication

Below is a press release from Ablechild about the prioritizing of issues on the Connecticut Governor’s 2012 agenda.

“The most important thing Connecticut can do now is to break the monopoly on psychiatric treatment,” (co-founder Sheila) Matthews says. “Medication shouldn’t be the first option addressing behavioral or learning issues and it certainly shouldn’t be the only one.”

Some readers may question why a press release about the over-proliferation of medication use in the child foster care population is reprinted in a blog on schizophrenia. While it is true that diagnosing schizophrenia in children is still rare, the diagnosing of ADD, ADHD and bipolar (schizophrenia’s look-alike twin) has grown by leaps and bounds. Most psychiatrists accept and promulgate the notion that there is a rare psychiatric condition called childhood schizophrenia. Up until now, the public has tended to accept this, just as it has accepted the pharmaceutical companies ‘ pronouncement that schizophrenics need antipsychotic medication just like diabetics need insulin. Robert Whitaker’s book, Anatomy of an Epidemic, revealed that pharmaceutical salesmen promoted this self-serving and false comparison in order to keep people from going off their medication.

I strongly suspect that the push to stop medicating children stops at schizophrenia, which is always upheld as a “special case,” just as it is in adults. When the public stops buying into the notion that adult schizophrenia is always a special case, effectively treated by drugs, the childhood schizophrenia diagnosis and the use of drugs to “treat” it will also be questioned. Childhood schizophrenia can be treated and should be treated, like any other childhood emotional disorder like ADD, ADHD and bipolar, without resorting to drugs. Ablechild is doing excellent work. Let’s make sure that treating childhood schizophrenia without drugs is part of its agenda.

Ablechild Urges Adding Overmedication of Children in State Care to Governor’s 2012 Agenda

Parent advocacy group to educate State of CT healthcare providers on the over-prescribing of psychotropic drugs to children in foster care.

WEBWIRE – Tuesday, January 03, 2012

WESTPORT, CONN., JANUARY 3, 2012—Ablechild co-founder Sheila Matthews will brief Connecticut State Healthcare Advocate Victoria Veltri today on the organization’s research into the over-prescribing of psychotropic drugs to children in foster care.

The parents’ rights organization is a sitting member of the Connecticut Behavioral Health Committee that reports directly to Governor Malloy. In today’s meeting, Matthews will share data from last month’s ABC News 20/20 report, which Ablechild helped develop. The show provided a first look at a new Government Accountability Report that found:

• Foster children were prescribed psychotropic drugs at rates nearly five times higher than non-foster children.

• More than a quarter of foster children were being prescribed at least one psychiatric drug.

• Hundreds of foster children received five or more psychiatric drugs at the same time, despite no evidence that this is safe or effective.

The meeting’s agenda includes a report on the $29,766,625,000 spent on psychiatric services by Connecticut’s Department of Children and Families, and Ablechild research showing how making educational, language and vision and hearing/speech solutions available can cut costs while enabling true informed consent for parents. “The most important thing Connecticut can do now is to break the monopoly on psychiatric treatment,” Matthews says. “Medication shouldn’t be the first option addressing behavioral or learning issues and it certainly shouldn’t be the only one.”

In a November briefing with Malloy’s legislative aide, Michael Christ, Matthews also pressed for action on Proposed Bill 5007. If passed, the landmark legislation would require the state to inform parents of their rights regarding diagnosis and treatment of behavioral and mental health disorders in children.

Since 2005, Proposed Bill 5007 has remained stalled in the Connecticut Legislative Education Committee subject to reintroduction by long-time committee chair, State Representative Andy Fleischmann. Matthews says, “It’s extremely frustrating that no action has been taken on this bill for over five years while special-interest and industry-backed legislation not only moves through committees rapidly, its backers have been given fast-track access to the legislative process itself.”

Malloy is preparing his 2012 agenda, which will be announced shortly before the legislature convenes in February. “Ablechild is pleased to support Governor Malloy as he sets his course for the year ahead,” says Matthews. “Connecticut was the first state to prohibit schools from recommending the use of psychotropic drugs, three years before it became federal law. We hope Connecticut will continue to show leadership through best-practice guidelines that protect its most vulnerable residents.”

About AbleChild

AbleChild is a nationally recognized nonprofit organization dedicated to parents, caregivers, and children’s rights alike. The organization is a clearinghouse for objective information regarding ADD, ADHD, and other behavioral issues. All services AbleChild provides are free to the public. To learn more, visit www.ablechild.org.

Acting helps soldier cope with post-traumatic stress disorder

I’m holed up here in my vacation pad (LOL) with only my Blackberry to link electronically to the blogging world. There is an interesting story in ocala.com on the value of acting for overcoming PSTD. Schizophrenia is essentially post-traumatic stress disorder, except the trauma that precipitates the psychosis is the former case is usually less obvious in the latter case. There is a time and a place for acting as part of a person’s recovery. As the article states, recovery is individualistic. People have to go with what works for them. My son, Chris, was introduced to acting classes in his two year recovery program, and his psychiatrist observed that Chris really “came alive” in this class. But it was only four or five years later that Chris started to seek out activities that put him on the stage. Recovery is personal. A good approach to it is the holistic one. Try a little bit of everything.

3 New Year’s resolutions

Most of these resolutions have to do with the memoir I have been writing and rewriting going on seven years now.  My writing has gotten better, or at least more precise, thanks to the freelance editor who is helping me whip the chapters into shape. Right now I’m working on the chapter on Family Constellation Therapy. I’m a bit like a plumber who has completely torn apart the kitchen sink in order to determine where the leak is. All the sentence nuts and bolts are strewn on the floor and I’ve got to figure out how to put them back in the right order to avoid taking the chapter apart again.

New Year’s Resolutions

1. Finish editing my book.

2. Finish editing my book.

3. Pepper my posts liberally with LOL.

Reason: I’ve been resisting introducing LOL into my posts ’cause I generally hate using popular and geographically based slang. It’s fine for other people who seem to know how to use LOL appropriately. I also fear a sense of humor doesn’t come across as well as I would like it to in my writing. Hence LOL. It will also make me look more carefree, almost as carefree as I feel these days.

Oh, yes, and Happy New Year everyone!

The placebo effect and the diagnosis effect

There is an article in the Dec. 19 edition of The New Yorker magazine about how the placebo effect is gaining new found respectability. The Power of Nothing: Could studying the placebo effect change the way we think about medicine? The subject of the article, Ted Kaptchuk, Director of the Program in Placebo Studies and the Therapeutic Encounter at Harvard’s Beth Israel Medical Center, believes that if the patient gets better, not because of a drug, but due to the placebo effect, shouldn’t the placebo be considered a useful took in the medical tool kit, as useful as any drug?

The article states that simply believing in the treatment can be as effective as the treatment itself. In several recent studies, placebos have performed as well as drugs that Americans spend millions of dollars on each year.

The New Yorker article started me thinking about how the placebo effect, which we all tend to positively associate with healing, could also be used in the opposite sense – being told you are not going to get better. The placebo effect is often used to demonstrate how amenable the human mind is to suggestion – if people believe they are going to get better, they often do. What then do we make of the mental illness diagnosis, the label that the psychiatrist hands out? The mental health diagnosis, critics charge, opposes the expectation of recovery. The worst mental health diagnosis, the one with the least prospect for recovery (for people who believe what the doctor tells them) is a diagnosis of schizophrenia.

Patients are told by the doctor that they have a life long illness, that can be managed by drugs. They are told there is no hope of being cured. Therefore, the patient correctly internalizes the diagnosis and his actions henceforth tend to uphold the diagnosis. It is my experience that people who reject the diagnosis and/or do not succumb to the medical model of the so-called disease are the ones who cure themselves. Looking at recovery incentives in the hard nosed context of money, the article states: In several recent studies, placebos have performed as well as drugs that Americans spend millions of dollars on each year, one might logically ask, well, why not give schizophrenia patients the equivalent of a placebo – the expectation of being cured? The patient’s mind will take over from there.

The diagnosis effect is much more sinister than the placebo effect, at least from what little we know of how the placebo effect is being manipulated in drug trials so far. The New Yorker article IMHO shows that in the future, it is possible that the placebo effect can be manipulated for noble and not so noble ends. The diagnosis effect, when it comes to a mental health label, casts a spell over the patient, his family, and anyone who connects the diagnosis to the patient.  I have heard people parrot exactly what the doctor tells them — that schizophrenia is life long, that not taking meds leads to relapse, that the disease itself, not the effect of the meds or the natural course of the illness at a certain point, dulls the mind. The family begins to treat the patient as a mental and emotional cripple. Whatever the patient may believe about the course of his condition is negatively reinforced every day by the family and others who believe that the original diagnosis is scientifically factual, and not something that can be tweaked by the power of suggestion.

Adults are not harmed by DSM labels

There is an excellent article by Paula Caplan, Ph.D.  in Psychology Today (Dec. 19).

 In “Who Will Protest Against the DSM Harm?”, Dr. Caplan points out the hypocrisy of some well known psychiatrists who have suddenly  (but not really) “seen the light” when it comes to societies most vulnerable citizens (children and the elderly.) We are only too aware that society’s vulnerable adults have been harmed for decades by the labels and the drugging, but a petition  by The American Psychological Association that is gaining huge momentum tellingly omitted adults from its list of those harmed, until Caplan pointed out this rather gaping hole to the petition’s coordinator.

The good news: More people than ever before are learning that psychiatric diagnosis is not grounded in good science and causes a vast array of harm to people who have turned for alleviation of their suffering to those who are called helping professionals. The bad news: The forces keeping the psychiatric diagnosis juggernaut rolling and misleading the public are more powerful than ever.

IMHO, psychiatry’s new found zeal to right past wrongs for certain groups is merely sensing which way the wind blows, but it is hoping to keep the public focused on cute children and elderly parents in nursing homes in order to divert attention away from the bulk of its clients, namely adults. Here’s a confession of mine, which I think I have already confessed to elsewhere in my blog. If an organization wants to be at the receiving end of warm fuzzies from the public while simultaneously enriching its own bottom line, focus on children. Psychiatry is no different from charities in that respect. What, no adults in need of our support? I ask myself before flicking the remote or failing to drop a coin or two into a cardboard box at the check-out counter. The widely promoted concept of “child poverty” is a particular bugbear of mine. Child poverty, I often snort. Children aren’t by themselves poor. They have poor parents. Bah humbug.

Caplan writes:
You may have heard about the petition started by several divisions of the American Psychological Association, who express concern about possible harm to children, adolescents, and the elderly and ask for an external group (the DSM is published by the American Psychiatric Association) to evaluate the proposals for the next edition, called DSM-5. This petition has garnered thousands of signatures and the support of additional American Psychological Association divisions. Although it is wonderful that these brave divisions have at last spoken out about the devastation caused to untold numbers of people over the many decades of the DSM’s existence, it is stunning that they would specifically omit mention of harm to adults who are not elderly.

There’s lots to ponder in her article. Please read it.

Calling all First Episode Schizophrenia Torontonians

FIRST-EPISODE SCHIZOPHRENIA
ALTERNATIVE MENTAL HEALTH TREATMENT
ONTARIO OUTREACH PROJECT
 
Raymond J Pataracchia ND, BSc © 2011/2012
Clinic Director, Naturopathic Medical Research Clinic
December 7, 2011

Our outreach project, localized to the geographic catchment of Southern Ontario and US vicinity, aims to provide an advanced drug-free treatment regimen that offers hope for first-episode schizophrenia (FES). First-episode schizophrenia is identifiable in people with consistent psychotic symptoms lasting 6 to 24 months. It is in this FES group that researchers believe early treatment offers the most benefit. Indeed it is in this group that there exists the greatest potential to bring brain chemistry back to a state of normalcy.

We are currently accepting patients for a one year open-label clinical trial (where everyone knows what the treatment is) and we encourage all interested to call our Toronto clinic toll free at 1-877-ORTH-871 or locally at 416-944-8824. Although medical referral is not mandatory, we work with an array of medical professionals and encourage inter-professional collaboration.

In this international outreach effort, the Naturopathic Medical Research Clinic (NMRC), located inToronto, Ontario, will use an advanced drug-free nutrient-based protocol with a central nutrient foundation that has been used successfully over the past half century.

We intend to report on the effectiveness of this unique first-episode treatment method in the sample of patients. Reporting will not only help future research efforts, but will also help society appreciate the value of a drug-free approach considered to offer profound hope.

It is important to note that FES patients taking drug medication can safely and simultaneously use this nutrient-based protocol. In society, we see a high drug drop-out rate in FES. Indeed many patients (upwards of 40%) opt not to take drug medication at all. With this existing demographic sample we aim to determine the comparative effectiveness of an advanced nutrient-based protocol in drug-naïve versus drug-medicated FES. Although the fact that the benefit of using neuroleptic drugs in FES is not established, the majority of modern day psychiatric researchers will assert: 1) that medication benefits outweigh apparent risks, 2) that maintaining medication while implementing an alternate treatment method does not negatively alter results or study validity and, 3) that drug sedative effects play a paramount role in maintaining socially acceptable society decorum.
 
We all look forward to the day when FES patients will be given the opportunity to live life free of major sedation. The NMRC treatment protocol archive on first-episode and chronic schizophrenia encompasses a comprehensive array of nutrient targeted patient data. Our archive supports the use of an exceptional model of wellness in FES. In considering the protocol of choice in first-episode cases, we have taken into account sixty years of evidence-based archives and a decade of in-house data on alternative clinical treatment outcomes in schizophrenia. The chosen FES protocol is a clinical nutrition vitamin and mineral regimen that combines adjunct thyroid treatment when indicated. The clinical nutrition component is an advanced and novel clinical nutrition (orthomolecular) regimen that addresses core nutrient deficiencies and dependencies. We consider this approach to provide the best treatment outcome scenario in FES.
 
There will be a comprehensive lab testing component integrated in this trial as we aim to determine the metabolic and biochemical factors that define good responders. There will also be a comprehensive component that assesses symptoms and quality of life functional recovery aspects. An international
outreach effort of this quality will facilitate an understanding of the most effective alternative treatment model for FES, and thereby offer hope to a segment of society that so drastically needs it.

This outreach project is considered an ‘in-house’ open-label research endeavor and as such does not
require grant funding or natural health product regulatory body approval. In this case, under this research design, eligible participants will be required to pay for a portion of assessment and treatment services and supplement costs. A four-part service package fee covers one year of assessment and treatment services. Monthly supplement cost estimates are available and vary depending on body weight and protocol allocation at the 6 month mark. At the 6 month mark, participants are allocated to either the thyroid or the multi-EPA treatment stream, and iron deficient cases are supplemented as indicated.

Eligible Candidates are those who:

i) have a diagnosis of FES or who through a collaborative effort in assessing symptoms are provided with a solid FES diagnosis; participants must be moderate to severely symptomatic and functionally semi-independent in society; diagnostic uncertainty excludes participation but candidates with prodromal symptoms of 1-2 years will be considered for a separate open-label trial with a streamlined treatment intervention;

ii) are on, off, or have never taken neuroleptic medication; if on medication, participants are not to discontinue or withdraw unless directed under psychiatric supervision; if progress is substantial and withdrawal from medication is indicated, this is to be done only as recommended under psychiatric supervision with the aim of maintaining the lowest effective dose to avoid receptor related confounds to treatment outcome (dose reductions should thereby not exceed 15% of the ‘stabilized’ dose ofneuroleptic every 3-6 months during the one year study protocol);

iii) are less than 2 years post-onset at the time of starting the protocol;

iv) are age 18 to 40; those aged 14-17 or 41-55 will be considered for a separate open-label trial with similar treatment intervention;

v) are willing to allow their progress to be documented by providing disclosure to report data on their case up to 5 years post-treatment (anonymity is respected in all cases);

vi) are committed to adhering to the protocol to ensure compliance; participants are excluded if they use other alternative treatments during the one year study protocol; participants must be able to form an alliance with the research team to comply with protocol structure; where possible, patients should be accompanied by caregivers to provide a support network that ensures compliance; a compliance contract is mandatory;

vii) are willing to pay for treatment and participate without subsidization; a heavily discounted rate applies to encourage access to all socio-economic populations; participants must be able to afford transportation to and from the Toronto clinic and other miscellaneous out-of-pocket expenses;

viii) do not have a history of a chronic condition that is a confound to treatment response; for example, active liver disease such as active hepatitis, illicit drug use, alcohol abuse, peptic ulcer, assaultive or flagrant uncooperative behaviour, or moderate to severe destructive behaviour.

____________________
Many thanks to Duane Sherry for spotting this study.

Worth repeating

Gianna Kali at Beyond Meds has posted some links to the inspiring work of Jungian analyst Maureen Roberts. I wanted to highlight just one of them for this post. Please read the rest of the article for an in-depth shamanic interpretation of schizophrenia.

from Schizophrenia: Your Questions Answered, by Maureen Roberts, Ph.D.

What is Schizophrenia?

A good question, with no simple, short, or straightforward answer, since each sufferer is unique and schizophrenia is a complex phenomenon. In general, schizophrenia is an extremely introverted, psychospiritual mode of perception, or way of relating to the world; or state of consciousness involving (what I have called) ‘extreme empathy’. This simultaneous blessing and curse is due to a fragile, fragmented, dead, or lost ego, or conscious personality structure. The normal, ego-enforced boundaries between the self and the world have broken down, such that schizophrenia sufferers – for better and worse – find themselves identifying with everything within their scope of perception. It is because of this ego loss, or ‘dis-integration’ that psychosis, shamanic initiation and mystical experience are so inextricably bound. The schizophrenic person may appear to family, friends and doctors to be lacking in emotion, but in reality is in a state of intense empathy, such that extreme sensations of joy and fear are usual. Because of their fragile personal boundaries, schizophrenic folk typically see, hear, sense, perceive and understand things that others are unaware of. Secret, or symbolic meanings are seen and heard in everything, and the schizophrenia sufferer typically feels responsible for the fate of the world.


Further reading: “Schizophrenia: The Shaman Sickness” by Sam Malone (former sufferer). Visit his website, which includes testimonies by schizophrenia sufferers. http://www.geocities.com/johnny_crowseed/sands/skzlike.html
(Editor’s note: The link provided does not work and I can find no trace of this website on the Internet.)

Welcome Om*

Our family will be escaping shortly to spend Christmas in a small village about a three hour drive from our city. This post is a bit of a seasonal wrap-up of family events and some observations on my part.

I picked up our youngest son, Taylor, at the airport on Sunday after depositing my husband, Ian, in time to catch his flight. Taylor was exhausted after his transatlantic flight and slept the rest of the day. Then, all three “boys” played video games till midnight. Taylor’s got one semester left of university before he takes on the challenges of a job and independent living. Alex, our middle son, is taking time off over Christmas from his current job. He, too, needs the rest. I managed to snag him into replacement ushering (for Ian) at our church but I had to resort to laying some heavy guilt on him. “You live at home, your rent is minuscule, you can offer to help out occasionally,” says Mom. Alex doesn’t do guilt. Never has. I admire him for that quality. Still, it took some pestering on my part to get him to don at least a sports jacket for the occasion.

On the other hand, we have Chris, who does do guilt, but is getting much better at questioning why he feels he has to take on the burdens of the world. To boost his resiliency in this area and others, Ian and I bought him a pre-Christmas gift – 36 hours of DVD lectures on Why Evil Exists, and 36 hours of lectures on Christian theology. I felt he needed a rush job, to have all his questions answered (LOL) before his first Saturn return 28th birthday in January. If all goes well, according to the Evil description, these 36 lectures offer you the unique chance to approach the subject of evil through numerous lenses and to refine your view of this central question of human life, giving you a broad and deep resource for your own thought and action. (Don’t tell Chris, but I also got him The Portable Nietzsche as a gift.) Chris’s problem/opportunity is that he thinks too much.)

Despite the guilt feelings, Chris is gaining lots of confidence in his voice. He turned in a strong performance as a soloist during the Nine Lessons and Carols service on Saturday evening.

“I am finding that I like the attention, Mom.”
“Great,” says Mom. “Keep doing more of what you like.”

The first Saturn return period (ages 28 to 30 or so) is a encouraging time for young men who may have been having mental health difficulties up until now. I was heartened to read how well Randye Kaye’s son is doing. In her post Randye does a superb job of describing how to support an individual through psychosis with humor.

At its best, humor creates partnership. At its worst, it is ridicule and bullying. The difference is often a matter of simple courtesy, but also a decision based on your sharpest instincts when it comes to those close to you. Tread carefully – but if results are encouraging, then proceed with joy. The results can be amazing.

What Randye describes is the humor variant of concept of Low Expressed Emotion. Although treating a person with respect appears obvious to getting positive results with someone else, in practice, many of us give into our darker impulses and we tear the person down by our looks and comments. In practice, it takes quite a while to learn how to get it right. I like what she writes “if results are encouraging, then proceed with joy.” Eventually, continuous respectful treatment becomes second nature to us.

Chris, on his own initiative, is beginning a Transcendental Meditation course. I had been gently suggesting for years that he may find peace in meditation, but, he wasn’t emotionally ready to take that step until now. Learning to meditate seems a fitting way to for him to end the year and to enjoy the mysteries of the years to come. I was delighted to read this Beyond Meds post from Will Meecham about meditation and building mental health resiliency:

Ever since starting this blog, I’ve sung the praises of meditation and right attitude as tools for building mental health. Not that many years ago I felt horribly familiar all the adjectives that open this post. I had tried many types of therapy and many different pharmaceuticals without much improvement. Eventually, I turned attention inward and began to work with my thoughts and feelings directly.

By clearing out misconceptions and misperceptions, I found clarity and readiness to accept whatever happens in life. I am not immune to grief and disappointment, but I am much more resistant to despair. Meditation succeeded where medication failed.

_____________
*Om
“The goal which all the Vedas declare, which all austerities aim at, and which men desire when they lead the life of continence … is Om. This syllable Om is indeed Brahman. Whosoever knows this syllable obtains all that he desires. This is the best support; this is the highest support. Whosoever knows this support is adored in the world of Brahma.”
~ Katha Upanishad I