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How can this be? Don’t bother asking because privacy laws shield the drug company applications for PBS listing from public scrutiny.

by Dr Martin Whitely

ADHD drug Concerta is a slow release form of methylphenidate (the active ingredient in Ritalin) that can be taken once daily.  It was first licensed for use in Australia by the Therapeutic Goods Administration (TGA) in 2003 and subsidised via the Pharmaceutical Benefits Scheme (PBS) for use by children in 2007.

Recently Concerta’s manufacturer Janssen-Cilag (a subsidiary of Johnson and Johnson) applied to “extend the current Authority required listing” on the Pharmaceutical Benefits Scheme for Concerta “to include use in patients diagnosed with attention deficit hyperactivity disorder (ADHD) after the age of 18 years”. The Pharmaceutical Benefits Scheme Advisory Committee (PBAC) “rejected the application on the basis of uncertain efficacy and safety in the proposed PBS population and hence uncertain cost-effectiveness, and high and highly uncertain cost to the PBS.”[1] In response Janssen Cilag commented that “Concerta is already available on the PBS for use in adults who were diagnosed with ADHD ≤ 18 years. This submission requested the same access for all adult patients regardless of the age at which they were diagnosed. We will consult with the PBAC with regards to a future resubmission.”[2]

Janssen Cilag raise a valid point; How can Concerta be ok for children and yet have “uncertain efficacy and safety” for adults? Read the rest of this entry »

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by Martin Whitely

8 July 2012

An article in today’s Sunday Age, available at http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html, highlights the results of a prescribing audit of Patrick McGorry’s Orygen Youth Mental Health Service.  It found the service “prescribed medication to a majority of depressed 15 to 25-year-olds before they had received adequate counselling, despite international guidelines advising against the practice.”[1]

The audit of 150 patients treated in 2007 found “75 per cent of those diagnosed with depression were given the drugs too early. Clinical guidelines recommend that in most cases antidepressants should only be given to young people after they fail to respond to four to six sessions of psychotherapy, which usually takes about six weeks. However, the audit, carried out by Orygen’s own researchers, found on average patients received the drugs after just 27 days. It also showed that fewer than half were followed up to see whether their symptoms had improved or to check for side effects, which can include an increased risk of suicide.”[2]

It is commendable that Orygen[3] published the results of the audit, however the results make a mockery of Professor Patrick McGorry’s often repeated assertion that drugs are not the first-line treatment in any but the most serious cases.

In response Professor George Patton, director of adolescent research at the Centre for Adolescent Health at the Royal Children’s Hospital, told The Age, ”This paper illustrates how much we need to be looking at these new services [EPPIC and headspace] to determine the extent to which we’re following best clinical practice and to ask the questions, are we getting value for money out of these investments, and are we actually seeing better clinical outcomes?”[4]

At the very least there is an obvious need for an independent scientific review of the EPPIC and headspace programs identified for national rollout and for tight real time program wide auditing of medication practice.

 

Note: The issues raised in today’s Age article reinforce similar concerns I voiced last year about antidepressant prescribing at Professor McGorry’s other favourite project headspace.  I raised my concerns in the WA State Parliament and on my blog last year titled “Is Patrick McGorry’s and the Independent Mental Health Reform Group’s $3.5b blueprint for Australian mental health the way forward, or a prescription for more ‘psychiatric disorders’, ‘off label’ prescribing and youth suicide?” available at http://speedupsitstill.com/patrick-mcgorry%e2%80%99s-independent-mental-health-reform-group%e2%80%99s-3-5b-blueprint-australian-mental-health-forward-prescription-%e2%80%98psychiatric-disorders%e2%80%99-%e2%80%98off-label

[1] Jill Stark, Youth mental health team too free with drugs: audit, The Sunday Age, July 8, 2012

http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html

[2] Jill Stark, Youth mental health team too free with drugs: audit, The Sunday Age, July 8, 2012

http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html

[3] Orygen runs a range of youth mental health services, including EPPIC (Early Psychosis Prevention and Intervention Centre), PACE (Personal Assessment and Crisis Evaluation), YMC (Youth Mood Clinic) and HYPE (Helping Young People Early, for people with emerging borderline personality disorder).  In addition, Orygen is a partner in headspace.

[4] Jill Stark, Youth mental health team too free with drugs: audit, The Sunday Age, July 8, 2012

http://www.theage.com.au/national/youth-mental-health-team-too-free-with-drugs-audit-20120707-21o29.html

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By Dr Martin Whitely

The central characteristics of ‘Disruptive Mood Disregulation Disorder’ proposed for inclusion in DSM5 are childhood “irritability” and “temper outbursts” occurring, ”on average, three or more times per week”.[1] Disruptive Mood Disregulation Disorder represents a disturbing evolution of the absurd and dangerous practice of diagnosing children, even very young children, with ‘Juvenile Bipolar Disorder’.  Although not an official psychiatric disorder Juvenile Bipolar Disorder was enthusiastically and successfully promoted by disgraced Harvard University Professor of Psychiatry, Joseph Biederman.

Biederman, who was also Director of the Johnson & Johnson Centre for Paediatric Psych-Pathology research at Massachusetts Hospital and according to the New York Times is the “the world’s most prominent advocate of diagnosing bipolar disorder in even the youngest children and of using antipsychotic medicines to treat the disease”.[2] He is largely responsible for the enormous growth in US antipsychotic prescribing rates to children including Johnson & Johnson’s very profitable antipsychotic Risperidone (brand name Risperidal).  In April Johnson & Johnson were fined US$1.2Billion by an Arkansas court for making misleading claims about the safety of Risperidal. This followed similar outcomes in other US states.[3]

In 2011, US congressional investigations led by Iowan Senator Charles E. Grassley exposed that Biederman received at least US$1.6m in undisclosed fees from drug-makers from 2000 to 2007 and only revealed a tiny fraction of this income to Harvard University.[4] The New York Times reports “court documents dating over several years that Dr. Biederman wants sealed showed that he told the drug-giant Johnson & Johnson that planned studies of its medicines in children would yield results benefiting the company”.[5]

Taking and not disclosing drug company money and planning beneficial research results is reprehensible behaviour. Harvard University’s decision to effectively give Biederman little more than a rap on the knuckles brings discredit to one of the world’s most prestigious universities.[6] Perhaps Harvard was motivated more by the funding that Biederman and his cronies attract to the university than by the damage they bring to the university’s reputation. Harvard’s failure to take strong ethical action against Biederman has meant that his influence, although waning, is still considerable.

Thankfully Juvenile Bipolar Disorder is not officially recognised as a diagnosable condition in the current DSM (DSMIV). Supporters lobbied to have it included in the DSMIV, however the DSMIV development committee “found scientific support unconvincing and refused to do so”.[7] Regardless, hundreds of thousands, possibly millions, of children have been diagnosed with the unofficial disorder and treated with anti-psychotics like Johnson & Johnson’s Risperidal.[8] These medications “can cause serious complications – major weight gain, obesity, diabetes, cardio vascular disease and possibly shortened life expectancy.  Sudden death has occurred in a few cases where excessive doses and/or multiple drugs were given to very young children.”[9]

The proposal to include Disruptive Mood Disregulation Disorder is in part a reaction to criticisms of the use of anti-psychotics for Juvenile Bipolar Disorder.  The authors of DSM5 are proposing Disruptive Mood Disregulation Disorder as an alternative to the diagnosis of Juvenile Bipolar Disorder, using the rationale that this will help curb anti-psychotic prescribing rates to children.  In effect, they are proposing a “juvenile bipolar light” disorder.

Given the unrestrained enthusiasm for prescribing psychotropics ‘off label’ to children exhibited by many clinicians, particularly paediatricians, the opposite is likely to occur.[10] The inevitable outcome is that more children will be diagnosed and experience tells us the more children diagnosed with a ‘psychiatric disorder’, the more children are subjected to the cheap and convenient practice of speculative ‘off label’ prescribing.

The only sensible course of action for the American Psychiatric Association is to reject out-of-hand the notion of Juvenile Bipolar Disorder or any lighter version thereof including Disruptive Mood Disregulation Disorder.  Failure to do so will drag the American Psychiatric Association into another epidemic of childhood drugging for which, unlike ADHD, they currently bear no responsibility.

 

[1] For a full description of the proposed diagnostic criteria see http://www.dsm5.org/proposedrevision/pages/proposedrevision.aspx?rid=397

[2] New York Times Topic Page for Professor Joseph Biederman available at http://topics.nytimes.com/topics/reference/timestopics/people/b/joseph_biederman/index.html]

[3] Companies belittled risks of Risperdal, slapped with huge fine, Los Angeles Times 11 April 2012. Michael Muskal available at http://articles.latimes.com/2012/apr/11/nation/la-na-nn-risperdal-arkansas-20120411

[4] New York Times Topic Page for Professor Joseph Biederman available at http://topics.nytimes.com/topics/reference/timestopics/people/b/joseph_biederman/index.html

[5] New York Times Topic Page for Professor Joseph Biederman available at http://topics.nytimes.com/topics/reference/timestopics/people/b/joseph_biederman/index.html

[6] For more detail see http://speedupsitstill.com/world-leading-adhd-%e2%80%98expert%e2%80%99-harvard-professor-joseph-biederman-sanctioned-hidden-drug-company-money-allegations

[7] Dr Allen Frances, Huffington Post, The false epidemic of Childhood Bipolar Disorder available at http://www.huffingtonpost.com/allen-frances/children-bipolar-disorder_b_1213028.html

[8] There are no reliable estimates of child prescribing patient numbers. In the U.S. outpatient office visits for children and adolescents with bipolar disorder increased 40-fold from 20,000 in 1994–95 to 800,000 in 2002–03. http://www.thedailybeast.com/newsweek/2011/06/19/mommy-am-i-really-bipolar.html

[9] Dr Allen Frances, Huffington Post, The false epidemic of Childhood Bipolar Disorder available at http://www.huffingtonpost.com/allen-frances/children-bipolar-disorder_b_1213028.html

[10] A recent study of psychiatrists in Christchurch New Zealand revealed that 96% of them prescribed antipsychotics off label. While it is unlikely that rate is replicated across the globe it is nonetheless an alarming statistic and indicates the practice is very common. M. Slezack, Psychiatry Update, 26 April 2012, 96% of psychiatrists prescribe off-label anti-psychotics  http://www.psychiatryupdate.com.au/latest-news/off-label-anti-psychotics-almost-universally-presc

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“As opposed to the ‘ongoing disability’ or ‘impending doom’ assumptions inherent in the Americanisation and  Preventative Psychiatry approaches, the Recovery approach is more optimistic about the capacity for recovery and less reliant on pills.  It supports mentally ill patients with housing, educational, employment and psychosocial support – building blocks for a healthy and happy mind that can’t be replaced by drugs.”

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The Scientific American recently published an article suggesting that “cognitive and behavioral therapies that help young people reduce impulsivity and cultivate good study habits are costlier and take longer to administer [than ADHD drugs], but may be more efficacious over time”.

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On May 2, 2012, the American Psychiatric Association announced changes to its proposed DSM5.[1. see http://www.dsm5.org/Pages/Default.aspx ]  Psychosis Risk Syndrome, or as it was officially proposed to be called, Attenuated Psychosis Syndrome, has been dropped. This is great news because as has been highlighted on this website numerous times, Psychosis Risk Disorder was a flawed concept with the potential to be an iatrogenic health disaster. In addition most of the dangerous changes proposed for the already absurdly broad ADHD diagnostic criteria have been abandoned.  Four extra ADHD criteria had been identified for inclusion in the DSM5. They were:

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A review of the medical records of 937,943 Canadian children showed that children born in December, the last month of their school year intake, were much more likely to be diagnosed and medicated for ADHD than their classmates born in January.

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The world’s most popular independent online news service, The Huffington Post, recently published two significant blogs suggesting that Western Australia and France offer lessons on how to tackle the global ADHD epidemic.

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When researchers expressed concern about ECT induced long term memory loss he scathingly dismissed them, despite having eleven months earlier proposed that pharmacological interventions may be warranted to alleviate that same side-effect.

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Anecdotal evidence indicates that too many Western Australian children in the care of the state that are managed rather than cared for.  Managed with a range of psychotropic drugs including, antidepressants, anti-psychotics, amphetamines and anti-anxiety ‘medications’ as a cheap substitute for the intensive support they so desperately need.

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