Tag Archives: pediatric bipolar

Neuroleptics for Children: Harvard’s Shame

In December 2012, Mark Olfson, MD, et al, published an article in the Archives of General Psychiatry.  The title is National Trends in the Office-Based Treatment of Children, Adolescents, and Adults with AntipsychoticsThe authors collected data from the National Ambulatory Medical Care Surveys for the period 1993-2009, and looked for trends in antipsychotic prescribing for children, adolescents, and adults in outpatient visits.  Here are the results:

Age Increase in no. of antipsychotic prescriptions per 100 population (1993-2009)
0-13 0.24-1.83 (almost 8-fold)
14-20 0.78-3.76 (almost 5-fold)
21+ 3.25-6.18 (almost 2-fold)

 

The authors provide a breakdown of the diagnoses assigned to the children and adolescents during the antipsychotic visits.

Diagnosis Visits %
Children
(0-13)
Adolescents
(14-20)
Schrizophrenia 6.0 8.1
Bipolar 12.2 28.8
Depression 11.2 20.9
Anxiety 15.9 14.4
Dev Disorders 13.1 5.0
Disruptive Behavior Disorders 63.0 33.7
Other Dx’s 18.0 16.8

 

Percentages do not total 100, because some individuals were assigned more than one diagnosis.

It is clear that disruptive behavior disorders are the most common diagnoses used in antipsychotic visits for both children and adolescents.

Thirty years ago, the prescription of neuroleptic drugs to children under 14 years of age was almost unheard of.  It was rare in adolescents, and even in adults was largely confined to individuals who had been given the label schizophrenic or bipolar.

By 1993, the first year of the Olfson et al study, about a quarter of 1% of the national childhood population were receiving antipsychotic prescriptions during office visits.  The percentage for adolescents was about three quarters of 1%.  By 2009, these figures had increased to 1.83% and 3.76% respectively.

The devastating effects of these neurotoxic drugs are well known, and it is natural to wonder what forces might be driving this trend.  The authors suggest that:

“Increasing clinical acceptance of antipsychotics for problematic aggression in disruptive behavior disorders may have increased the number of children and adolescents (especially male youths and ethnic/racial minorities) being prescribed antipsychotics.  The increase in the number of clinical diagnoses of bipolar disorder and autistic spectrum disorders among children and adolescents may have further increased antipsychotic use by youths, particularly by boys.”

They also note that:

“The trend in the prescribing of antipsychotics to youths occurred within the context of a dramatic increase in the clinical diagnoses of bipolar disorder among young people.”

The notion that the increase in the prescription of neuroleptics for children is driven by increased use of the bipolar diagnosis is supported by another study:  Most Frequent Conditions in U.S. Hospitals, 2010,  by Plunter et al, January 2013, published by the Agency for Healthcare Research and Quality (a division of the US Department of Health and Human Services).  This study, which analyzed hospital admission data from 1997 to 2010, found that mood disorder, which in 1997 had been in the fourth place (behind asthma, pneumonia, and appendicitis) was by 2010 the most common diagnosis for children aged 1-17.  In the 13-year period admissions for mood disorders had increased 80%, while admissions for asthma and pneumonia had decreased by 30% and 16% respectively.

Most of the increase in mood disorder frequency was for bipolar disorder.  In the period studied, admissions for children for depression rose 12%, but admissions for bipolar disorder rose 434% (from 1.5 per 100,000 population to 8.2).  For children in the age group 5-9, the increase was 696%! – a seven-fold increase.

So, over the last decade or two, we’ve seen a huge increase in the number of children being hospitalized for bipolar disorder and in the number of children being prescribed neuroleptics in office visits.

HOW DID THIS HAPPEN?

Neuroleptics are probably the most damaging drugs used in psychiatry.  The adverse effects, including permanent and extensive brain damage, are devastating, and occur in virtually all of cases where use is prolonged (Breggin, 2011, p 197).  In former decades, their use was confined mainly to adults who had been labeled schizophrenic or bipolar.  It was routinely claimed by psychiatrists that their benefits outweighed the risks, though this contention is not standing up to the increasing scrutiny that has occurred in the past decade or so.

The increase in the prescription of neuroleptic drugs for children is a direct consequence of the increased use of the bipolar label in that population.  And most of the responsibility for that increase can, in my view, be laid at the door of one person:  Joseph Biederman, MD, of Harvard Medical School and Massachusetts General Hospital.  Dr. Biederman will go down in history as the inventor of pediatric bipolar disorder.

DSM-III-R was published in 1987.  It makes no reference to the existence of childhood bipolar disorder.  The total entry under Prevalence is:

“It is estimated that 0.4% to 1.2% of the adult population have had bipolar disorder.” [emphasis added]

DSM-IV, published in 1994, greatly expanded the concept of bipolar disorder, essentially by removing the requirement of a manic episode or a mixed (manic-depressive) episode.  References to age are vague – e.g.:

“Approximately 10%-15% of adolescents with recurrent Major Depressive Episodes will go on to develop Bipolar I disorder.”

It is not clear whether this “development” might occur in late adolescence or in adulthood. There is no suggestion that bipolar disorder can occur in a pre-adolescent child.

By 1996, however, Dr. Biederman and his colleagues at Harvard were promoting childhood bipolar disorder as an accepted psychiatric diagnosis that needed to be treated with pharmaceutical products, including neuroleptics.  This was accomplished primarily by selling the notion that childhood temper tantrums could legitimately be regarded as symptoms of mania.  This blatant distortion of the traditional concept of mania was facilitated by the “not otherwise specified” (NOS) qualifier which has been a component of almost all diagnostic categories since DSM-III.  The purpose of the NOS diagnoses is to enable psychiatrists to assign the diagnosis in question to an individual even though he doesn’t actually meet the criteria.  The fact that this renders the criteria somewhat pointless is generally lost on psychiatrists, but that’s a different story.

What the Bipolar Disorder NOS diagnosis enabled Dr. Biederman and his colleagues to say was essentially this:

We know that temper tantrums aren’t really an integral component of bipolar disorder as it is traditionally conceived.  But we believe that that’s how bipolar disorder presents itself in young children, and so that’s what we’re going to call it.

This is on a par with dermatologists deciding that pattern baldness is a symptom of psoriasis!  In real medicine, this isn’t how it’s done, but in psychiatry it’s the norm.  The “diagnoses” are fictitious.  They can be created, modified, and eliminated with strokes of a pen.  This is what Dr. Biederman and his Harvard colleagues did, and American psychiatry followed.  The neuroleptics-for-children spigot was opened, and is running freely to this day.

The creation and promotion of pediatric bipolar disorder has been described and critiqued by several writers.  Joanna Moncrieff, a British psychiatrist, provides an excellent account in her book The Bitterest Pills (2013 , p 200-205).  Here are some quotes:

“Although it is the adult market that accounts for the bulk of sales of atypical antipsychotics, it is the use of these drugs in children alongside the emergence of the diagnosis of paediatric bipolar disorder that best illustrated the way in which a severe mental disorder can be morphed into a label for common or garden difficulties, as well as the role that money plays in this process.”

“Moreover, by locating the problem in the brain of the child, it seemingly detaches it from the situation within the family.”

“Academic psychiatry fuelled this craze, with added financial incentive from the pharmaceutical industry…”

“In the 1990s, a group led by child psychiatrist Joseph Biederman, who was based at Massachusetts General Hospital and the prestigious Harvard Medical School, started to suggest that children could manifest ‘mania’ or bipolar disorder, but that it was frequently missed because it was often co-existent with other childhood problems like ADHD and ‘antisocial’ behaviour…  In a paper published in 1996 the group suggested that 21% of children attending their clinics with ADHD also exhibited ‘mania’, which was diagnosed on the basis of symptoms such as over-activity, irritability and sleep difficulties…  A year later the group were referring to bipolar disorder in children as if it were a regular, undisputed condition, and emphasized the need for ‘an aggressive medication regime’ for children with the diagnosis…”

“Neither Harvard nor Massachusetts General Hospital nor any other psychiatric or medical institution has commented on the fact that prominent academics were found to be enriching themselves to the tune of millions of dollars through researching and promoting the use of dangerous and unlicensed drugs in children and young people.  Although some individual psychiatrists have expressed misgivings…academic papers continue to discuss the diagnosis, treatment and outcome of bipolar disorder in children as if no controversy existed, with more than 100 papers on the subject published in Medline-listed journals between 2010 and 2012.  Notwithstanding…the disgrace of Joseph Biederman, the practice of diagnosing children with bipolar disorder and treating them with antipsychotics remains alive and kicking.”

The spurious creation of childhood bipolar disorder has been critiqued also by Mickey Nardo, MD, a retired psychiatrist who blogs under the name 1 Boring Old Man (which, incidentally, he isn’t).  On July 2, 2011, he published a post called bipolar kids: an all too familiar lingo…  Here are some quotes:

“What happened in that second half of the 1990s is that they created a new diagnosis – Pediatric Bipolar Disorder. Looking at these articles…or at the COBY Study [started right around this time], Bipolar Disorder in children was becoming a common diagnostic term, but the diagnostic criteria bore little resemblance to the familiar symptom complexes from the Manic Depressive Illness of old. It was something new masquerading as something old [or vice versa]. These kids weren’t euphoric, they were irritable.”

“…the Biederman-led movement to broaden the category to call all kinds of difficult and disruptive children Bipolar had little to no scientific basis. It felt like a rationalization to use the new atypical antipsychotics to control difficult behavior-disordered kids – a trick.”

“And even without knowing what we know today about what happened, at the turn of the last century there was plenty of reason to smell a rat [named pharma]. The articles had all the tell-tale phrases – “urgent public health problem” “emerging new treatments” “need for more research” – an all too familiar lingo that pointed down a well-traveled yellow brick road. And this time it didn’t lead to Oz, it lead to Harvard University. And the guy behind the curtain was Joseph Biederman …”

Ultimately Dr. Biederman was disgraced – not for the spurious expansion of a diagnostic category.  Diagnostic expansion has been psychiatry’s primary agenda for the past 60 years.  A small minority of psychiatrists might have had reservations concerning Dr. Biederman’s work, but the mainstream psychiatry-pharma alliance embraced the new development with their customary zeal and self-serving enthusiasm.

Nor was Dr. Biederman disgraced because he had deliberately encouraged the exposure of thousands of children to neurotoxic chemicals.  Again, that’s just business as usual.  And in fact, he received awards and accolades for drawing attention to the plight of these tragically “underserved” children.  Here are some of the awards and honors he has received since his ground-breaking work on childhood bipolar disorder:

  • NAMI Exemplary Psychiatrist Award
  • NARSAD Senior Investigator Award
  • ADHD Chair of World Psychiatric Association
  • Outstanding Psychiatrist Award, Massachusetts Psychiatric Society
  • Excellence in Research Award, New England Council of Child and Adolescent Psychiatry
  • Mentorship Award, Psychiatry Department, Massachusetts General Hospital
  • William A. Schonfeld Award for outstanding achievement and dedication
  • Distinguished Service Award, MGH/McLean Child and Adolescent Psychiatry Residency

He was disgraced for under-reporting to his employers at MGH and Harvard the amount of money he was receiving from the pharmaceutical industry for conducting research that was used to promote their products.  Here again, there was nothing particularly unusual in this.  The so-called Key Opinion Leaders (KOL’s) in psychiatry have been awash in pharma money for decades.  But Dr. Biederman’s take ($1.6 million) was on the high side, and came to light at a time when the corrupt psychiatry-pharma alliance was being exposed nationally, largely through the efforts of Iowa Senator Charles Grassley.

Dr. Biederman was also criticized for promising Johnson & Johnson a positive result for their neuroleptic drug risperidone in pre-school children before he had actually conducted the research.  Obviously this makes a mockery of the research, but psychiatric research was hijacked by pharma marketing decades ago.  It has long since ceased to be a source of genuine scientific information, and much of it instead is little more than marketing material bought and paid for by the pharmaceutical industry.  Dr. Biederman’s error in this area was that he committed his promises to writing (in the form of slides that he presented to Johnson & Johnson executives), and these slides and other correspondence came to light during lawsuits against Johnson & Johnson for fraudulent marketing of their products.  These are the same lawsuits that Johnson & Johnson recently settled for $2.2 billion.

The great irony with regard to Dr. Biederman’s premature promise of a positive result for Johnson & Johnson is that he was absolutely correct!  If you give a neuroleptic drug to a misbehaved child, the incidence of misbehavior will indeed decrease.  If you give him enough, he’ll go to sleep and won’t misbehave at all!  That’s why these drugs used to be called major tranquilizers.  Dr. Biederman could accurately predict this result in advance because that’s what major tranquilizers do.  If you conduct a study to see if alcohol will make people drunk you’ll get a positive result.  If you conduct a study to see if major tranquilizers subdue childhood temper tantrums, you’ll get a positive result.  Dr. Biederman couldn’t use this defense, however, because he, like psychiatrists in general, has to play along with the big fiction:  that childhood temper tantrums are a symptom of an illness, and that the drugs are medicines targeting specific faults in neural circuitry or chemical imbalances or whatever.  Dr. Biederman’s proposed study would have produced a positive results for Risperdal in the same way that most industry-sponsored studies obtain positive results:  by limiting outcome criteria to the known effects of the drug, by keeping follow-up times short, and by ignoring adverse effects.

Dr. Biederman’s ethical lapses were thoroughly investigated (for three years) by his bosses at MGH and Harvard, and in 2011 they gave him and two of his colleagues (Thomas Spencer – total take:  $1.0 M, and Timothy Wilens – total take:  $1.6 M) very, very severe slaps on the wrists.  The Boston Globe covered this story.  Here’s a quote:

“The three psychiatrists apologized in their letter for the ‘unfavorable attention that this matter has brought to these two institutions.’  They called their mistakes ‘honest ones’ but said they ‘now recognize that we should have devoted more time and attention to the detailed requirements of these policies and to their underlying objectives.’

They said the institutions imposed remedial actions, requiring them to refrain from all paid industry-sponsored outside activities for one year, with an additional two-year monitoring period during which they must obtain approval before engaging in paid activities. They were also required to undergo unspecified additional training and suffer ‘a delay of consideration for promotion or advancement.'”

The notion that the ethical lapses of these three psychiatrists were “honest mistakes” is a little hard to credit, given that the total dollar amount was more than $4 M!

Today Dr. Biederman is fully rehabilitated and is back in business. He’s receiving research funding from ElMindA, Janssen, McNeil, and Shire, and is once again churning out research papers on topics such as ADHD and, guess what? – pediatric bipolar disorder.

THE BIG QUESTIONS

The two big questions in all of this are:

1.  Why do Harvard and Massachusetts General Hospital stand for this kind of blatant corruption and deception in the upper echelons of their psychiatry department?

2.  Why does the APA not take a stand against the medicalization and drugging of childhood temper tantrums – a problem that parents of previous generations simply took in their stride as an integral part of normal childrearing?

With regards to the APA, it’s really not much of a question.  Their agenda has always been: more psychiatric drugs for more people, and the neuroleptics-for-children development is really just business as usual.  They have dulled their ethical sensibilities through decades of prescribing benzodiazepines, SSRI’s, methylphenidate, and various other neurotoxins for an ever-widening range of human problems, and prescribing a neuroleptic to a 1½ year old for temper tantrums is a short step.

The APA, however, did express some mild concern about the spurious extension of the bipolar label to children.  In DSM 5 (p 132) they state:

“In individuals with severe irritability, particularly children and adolescents, care must be taken to apply the diagnosis of bipolar disorder only to those who have had a clear episode of mania or hypomania – that is, a distinct time period, of the required duration, during which the irritability was clearly different from the individual’s baseline and was accompanied by the onset of Criterion B symptoms.”

But rather than risk losing the pediatric business, hard-won by Harvard’s psychiatrists, they created a new diagnosis:

“When a child’s irritability is persistent and particularly severe, the diagnosis of disruptive mood dysregulation disorder would be more appropriate.”

The effect of all this is that psychiatrists can go on prescribing drugs for childhood temper tantrums, but instead of calling them bipolar disorder, they should use the new label:  disruptive mood dysregulation disorder – but they can continue to use the bipolar diagnosis also, with a few caveats, couched in the APA’s characteristically vague language.

Harvard’s stance on the scandals is a little harder to fathom.  After all, Harvard is hallowed ground – America’s Oxbridge.  It has acquired an image as a center of learning where educational and research standards eclipse all other considerations.

And in fact, there are legal and medical ethicists at Harvard who clearly recognize the implications of the psychiatric scandals.

Earlier this year, the Journal of Law, Medicine & Ethics (Vol 41, Issue 3) published a symposium of 17 papers written by members of Harvard’s Edmond J. Safra Center for Ethics.  Here are some of the titles:

Here are some quotes:

“The pharmaceutical industry has corrupted the practice of medicine through its influence over what drugs are developed, how they are tested, and how medical knowledge is created.” (Light et al)

“In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests.” (Cosgrove and Wheeler)

“Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behavior and decision-making.” (Sah and Fugh-Berman)

Clearly these papers are addressing important and relevant topics.  But what’s particularly noteworthy, from the present perspective, is that they originated in Harvard – the same institution in which senior psychiatry faculty members were hand-in-glove with pharma in the production of fraudulent research and advertizing.  How are we to understand this contradiction?  How are we to understand the minimal response from Harvard’s management, and incidentally from the other academic departments, given that such a wealth of ethical resources was there on their own campus, presumably available and willing to be consulted on these kinds of matters.

BUSINESS ETHICS VS UNIVERSITY ETHICS

In America, it is becoming increasingly recognized, and even accepted, that big businesses are frequently amoral.  Considerations of right and wrong are routinely subordinated to bottom line accounting.  Many big pharmaceutical companies are perceived in this light.  Indeed, the recent $2.2 B  penalty levied against Johnson & Johnson was discussed in some media outlets quite simply as a “cost of doing business.”  The question of whether it is a good thing to promote the use of neuroleptics for children doesn’t even come on the radar.  The perverse calculus is reduced to the difference between the projected profits from the drugs sales, and the fines and lawsuit settlements that might ensue.

Has Harvard’s Psychiatry Department, in concert with their pharmaceutical allies, crossed this line?  Have they now, implicitly or explicitly, adopted the ethical standards of the business world?  Have they subordinated their sense of decency and shame to considerations of prestige and revenue?

And what of the MGH/Harvard leadership?  Do they actually believe that the sanctions imposed on Dr. Biederman and his colleagues are adequate?  Or do they reckon that the years of past and future pharma revenue are worth the cost?  Have they crossed the line into the shady realm of business ethics?

And as we ponder these thorny questions, let’s not forget that the Johnson & Johnson lawsuit listed psychiatric researchers at other renowned universities, including Johns Hopkins, Stanford, UCLA, University of Illinois at Chicago, University of Texas at Austin, Georgia Regents, University of Toronto, and Dalhousie University.

Meanwhile the destructive prescribing continues, and Dr. Biederman is still at MGH, where he is Chief of the Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, and at Harvard, where he is a full Professor of Psychiatry, a position, which, by his own account, ranks just below God!

Psychiatry’s primary agenda for the past 60 years has been the expansion of their diagnostic net to embrace an increasing range of ordinary human problems, and the unscrupulous prescribing of more and more psycho-pharmaceutical products to more and more people.  In the final analysis, Dr. Biederman’s problem was that he was particularly good at this job.  He was, in effect, a Model Psychiatrist – the perfect embodiment of everything that the APA stands for.

CLARIFICATION OF TERMINOLOGY

My frequent use of the term bipolar disorder in this article should not be interpreted as an endorsement on my part of the ontological validity of this expression, much less its status as an illness or disease.  I use the term bipolar disorder (and the various other so-called diagnoses) for the sake of readability and linguistic convenience.  What I mean by “bipolar disorder” is:  the vaguely defined and loosely clustered behaviors, thoughts, and feelings that psychiatrists call bipolar disorder.