http://www.opednews.com/articles/Drug-Companies-Killing-Ki-by-Dr-Stuart-Jeanne-B-110513-689.html
May 30, 2011
By Dr Stuart Jeanne Bramhall
The Myth of Childhood Bipolar Disorder
Practicing psychiatry for eight and a half years in New Zealand has given me a unique perspective on childhood bipolar disorder, in my view the most dangerous "made in America" condition. This, too, is a condition virtually unknown outside the US. My membership in the Royal Australian and New Zealand College of Psychiatrists has led to an acquaintance with Melbourne psychiatrist Dr. Peter Parry and his work exposing a conspiracy by Eli Lilly and other American drug companies to pressure psychiatrists, pediatricians and primary care physicians to prescribe dangerous antipsychotic drugs "off-label" to American children.
Drug Companies Are Deliberately Breaking the Law
Prescribing "off-label" refers to using medication for an indication that hasn't been approved by the FDA. As yet no antipsychotics have been approved for use in children - drugs must meet extremely high safety standards for the FDA to allow their use in children. Moreover it's illegal for drug companies to market medications to doctors or the public for "off-label" uses. However the fines they pay are so miniscule compared to the massive potential profits, that it's considered good business practice to pay the fine and keep on doing it anyway. (see http://www.msnbc.msn.com/id/32694936/ns/business-us_business/, http://www.cheatingculture.com/off-label-marketing/, and http://www.false-claims-act.com/2010/02/09/eli-lilly-settles-for-largest-criminal-fine-in-us-history/
As well as publishing numerous studies on the controversy over childhood or pediatric bipolar disorder (PBD), Dr. Parry has put together a Power Point presentation that he gives at grand rounds and conferences around the world (see http://www.blackdoginstitute.org.au/docs/PaediatricbipolardisorderacontroversyfromtheUSA.pdf ). In addition to summarizing all the academic research on both sides of the issue, Dr Parry has also gained access to internal Lilly and Janssen memos (see slides 91-94 and 98-100) about their innovative campaign to "medicalize" children's behavioral problems by promoting the concept of pediatric bipolar disorder to American doctors and parents.
Diagnostic Criteria for Bipolar Disorder
Parry's slideshow starts with studies comparing US attitudes about pediatric bipolar disorder to those in the UK, Germany, New Zealand and Australia. For the most part, foreign psychiatrists either don't recognize pediatric bipolar disorder as a diagnosis or regard it as extremely rare. According to Dr Parry, the discrepancy revolves mainly around an insistence (outside the US) that both children and adults manifest symptoms of true mania to be diagnosed bipolar. By definition this requires one week or more of continuous euphoria or anger mood, accompanied by rapid thoughts and speech and extreme agitation. Over the past 10-15 years, an increasing number of industry-funded psychiatric researchers have been claiming that extreme temper outbursts, rages and rapidly changing moods are a "manic" equivalent in children. They also claim children with extreme mood swings will go on to develop true bipolar illness in adulthood and that early treatment will minimize the severity.
Increasingly this is proving not to be true, as only a small percentage of children diagnosed with pediatric bipolar disorder (and started on antipsychotics) ever experience genuine manic episodes.
Fortunately an increasing number of American child psychiatrists are also challenging the alarming trend of starting children as young as age two on antipsychotics for severe anger and behavioral problems. They are also increasingly concerned that psychiatrists and pediatricians are making the diagnosis of childhood bipolar disorder without obtaining full developmental histories (to screen for trauma and attachment difficulties, the most common cause of extreme mood swings) or classroom behavior information from teachers. The antipsychotics and anticonvulsants used to treat pediatric bipolar can have quite dangerous side effects. There are scores of deaths associated with their use in children, in addition to serious long term medical complications.
Omitting All-Important Developmental History
Understanding why foreign psychiatrists are so scandalized by their American colleagues' cavalier attitude towards pediatric bipolar disorder (and prescribing dangerous antipsychotic drugs to young children) requires an elementary understanding of the research-validated model of child personality development traditionally used by child psychiatrists and psychologists in assessing emotional and behavioral problems. This approach is based on the premise that accurate assessment of any child's difficulties must always assume that they are a product of their environment. If children with extreme rages and temper outbursts come from a chaotic home where parents are constantly yelling and screaming, these problems must be recognized as a "developmental" problem, rather than mental illness. In other words, a negative family environment has caused some aspects of the child's emotional development to be delayed. Diagnosing a child with a mental illness such as bipolar disorder (commonly known as scapegoating) - when the problem really lies with the parents - does both the child and the family a great disservice.
This developmental approach theorizes that all babies are born without the ability to regulate anger and other extreme emotions. In infancy and early childhood, parents help children regulate their emotions through soothing and calm limit setting. Via a constant repetition of this process, children eventually learn to regulate extreme emotion on their own. Where a problem commonly develops is when parents themselves have never learned emotional regulation and respond to children's anger and distress by losing their temper.
At the same time delays in the ability to regulate extreme emotion can occur for reasons other than inconsistent parenting. The two most common are trauma (physical, emotional and/or sexual abuse) and attachment difficulties (the child fails to bond appropriately with the primary caregiver). Physical and emotional abuse may stem from school bullying or an abusive sibling and have nothing to do with poor parenting.
The Dangers of Checklist Diagnosis
PBD Checklist by WebCalcSolutions
In Europe and here in the South Pacific, child psychiatrists argue that to demonstrate the presence of a mental illness such as pediatric bipolar disorder (PBD), the treating psychiatrist must demonstrate (by taking a careful developmental history) that the child previously had the ability to regulate extreme mood swings that was lost when the "illness" developed. Clearly this isn't being done, as many PBD aficionados, claiming that developmental and school histories are unnecessary, are making the diagnosis based on mood checklists alone. A checklist approach to diagnosis is extremely dangerous in children. The tendency for all children under stress to n to manifest extremes in mood and behavior (as all parents of young children will agree) makes it impossible to define the limits of normal mood and behavior.
What foreign and some American child psychiatrists find particularly horrifying about is the large number of children in the foster care system - who clearly have developmental issues based on abusive and neglectful homes - receiving the diagnosis of PBD and being put on antipsychotics to control anger and behavioral problems. In most cases this involves a cocktail of three to four drugs. In my experience, it's quite rare for them to be given a single medication (the reality is that antipsychotics don't work that well in children - they have little therapeutic effects other than sedation). Typically, in addition to the antipsychotic, they will be given an anti-seizure medication (used commonly in adult bipolar patients), an antidepressant, lithium, and/or clonidine (a blood pressure medication that calms children by dropping their blood pressure).
Why Are American Psychiatrists Diagnosing PBD
Dr Peter Parry puts the blame for the dangerous fad of prescribing unapproved antipsychotic drugs for children squarely where it belongs: on multinational drug companies and US insurance companies. While internal memos (see http://www.blackdoginstitute.org.au/docs/PaediatricbipolardisorderacontroversyfromtheUSA.pdf slides 91-94 and 98-100) show that drug companies deliberately set out to expand sales of antipsychotics by persuading doctors to prescribe them off-label to kids, the intrusion of for-profit insurance companies into US health care delivery has clearly played a role in perpetuating the barbaric practice. Even where a child has severe emotional problems, insurance companies refuse to pay for psychiatric visits or hospitalization without a diagnosis of mental illness. Moreover only drug treatment is covered, even if the difficulties result from family problems.
Psychiatric Researchers on the Drug Industry Payroll
Meanwhile child psychiatrists who feel uneasy prescribing dangerous antipsychotic medication to children are cheered on by pre-eminent researchers in their field, who issue stern warnings about ruining a child's future life by "missing" the diagnosis. Unfortunately most of the self-proclaimed pediatric bipolar disorder (PBD) experts neglected to disclose that they had a conflict of interest, in the form of hundreds of thousands of dollars in research grants and consultant fees from the drug companies who produce antipsychotics. This has only come out in subsequent lawsuits (see http://www.psychsearch.net/lawsuits.html) and ethical investigations (http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/).
In addition to pressure from insurance companies and PBD experts, child psychiatrists and pediatricians also experience major pressure from parents, owing to massive direct-to-consumer marketing -- in the form of dozens of books, magazine articles and TV documentaries promoting PBD as the only explanation for severe behavioral problems -- and a magic pill as the easy answer. Many of these parents, convinced by all the media hype, feel justified in demanding doctors prescribe these wonder drugs for their kids. Pity the poor child psychiatrist who stands firm on recommending the appropriate, evidence-based treatment - a lengthy course of family or behavioral treatment that isn't covered by insurance.
Death and Other Dangerous Complications
The complications of antipsychotic treatment in children fall into four broad categories: death, severe medical complications, social exclusion and delayed emotional development.
1. Death
As Dr Parry points out in his slideshow, fifteen years of FDA adverse incident reports (which typically capture only 1% of adverse drug events) reveal that antipsychotics are directly implicated in the death of scores of children:
2000-2004: 45 deaths (source http://www.usatoday.com/news/health/2006-05-01-atypical-drugs_x.htm)
2006: 29 deaths (source http://www.nytimes.com/2007/05/10/health/10psyche.html?pagewanted=1)
2. Severe Medical Complications
Antipsychotics tend to cause massive weight gain -- often as much as 100 pounds -- which commonly leads to diabetes. In addition a disfiguring neurological disorder called tardive dyskinesia that occurs in 6-9% of children who take antipsychotics. The tics and writhing movements associated with tardive dyskinesia often persist permanently, even after the medication is stopped.
3. Social exclusion
Labeling a child with a mental illness, particularly if they are taking a medications that cause sedation, extreme weight gain and/or tics has an extremely detrimental effect on their social relationships, which are absolutely vital to normal child development.
4. Delayed emotional development
Sedating a child who has difficulty regulating anger and extreme moods only further delays the process of learning to regulate their emotions themselves.
Do Child with PBD Grow Up Bipolar?
The main argument used for aggressive diagnosis and treatment of PBD is that treating bipolar illness early gives a child a better chance of leading a normal adult life. However now that increasing numbers of children with so-called PBD are in their twenties and thirties, it turns out that the vast majority "outgrow" PBD in adulthood. These results have led some American researchers to reach the same conclusion developmental psychiatrists and psychologists reached a decade ago: that the extreme mood swings being labelled PBD are actually a developmental problem that improves with brain maturation.
http://www.sciencedaily.com/releases/2008/10/081006180654.htm
http://www.sciencedaily.com/releases/2009/09/090929141530.htm