September 22, 2008

Pediatric Mania: The FDA's Definition

As most of you know, last week the FDA sent me what it's calling the official definition of pediatric bipolar disorder, at least to the degree that the agency will use the definition to approve drugs for the alleged disorder. What the FDA is leaning on for its definition is a paper published in 2007 called "Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder."

Keep in mind that the FDA says it is relying upon "science" in making its determination that pediatric bipolar disorder is a valid diagnosis. I think it's relying upon politics.

As I noted last week, the paper does not discuss or in any way delineate depression in pediatric cases of alleged bipolar disorder. I find that very strange, particular when it comes to discussing bipolar disorder in teens (still technically pediatric cases). The paper, and one assumes the FDA's definition, is almost entirely focused on what the authors call mania or manic-like symptoms. Despite that focus and a lengthy discussion of relevant literature, the authors never arrive at a firm description of the clinical features of "mania" in pediatric cases. In other words, they never trot out in DSM fashion the symptoms of the alleged disorder nor define its precise duration. If that's science, then the FDA also believes in cold fusion.

In reality, I have no problem with the validity of bipolar disorder in 12 year olds or above, so the teen/adolescent piece of pediatric bipolar disorder is non-controversial to me. (How accurate those diagnoses may be in the real world and how much wrong diagnosing is, or isn't going on, is another story.)

It's the juvenile, or child, piece that to me is off the rails. The paper's authors offer the following:

"A consensus conference of experts advised the U.S. Food and Drug Administration (FDA) to only extend medication treatment studies down to age 10 years, given concerns about the challenge of accurate diagnosis in younger children (Carlson et al., 2000). Until the validity of the diagnosis is established in preschoolers, caution should be taken before making the diagnosis in anyone younger than age 6 years."

What about the 6 to 9 year olds? And, to be clear, this is almost entirely about boys:

"Although overall bipolar disorder affects both sexes equally, early-onset cases are predominantly male, especially in cases with onset before age 13 years."

So what is meant by this boyhood mania that gets kids diagnosed with pediatric bipolar disorder?

"Changes in mood, energy levels, and behavior are often markedly labile and erratic rather than persistent. Irritability, belligerence, and mixed manic-depressive features are more common than euphoria. High rates of comorbid disruptive disorders are commonly found. Studies vary somewhat in their descriptions of early-onset cases. Findling et al. (2001) found that bipolar disorder in both children and adolescents is cyclical, had high rates of rapid cycling, and had low rates of interepisode recovery. In a series of studies by Biederman and colleagues (Biederman et al., 2004a,b; Wozniak et al., 1995), children with juvenile mania most often present with mixed episodes (primarily irritability and explosiveness), with chronic impairment, including some patients for whom the illness represents their baseline functioning."

So that's it. The Harvard bipolar child army has won, despite the heavy funding of their research by pharma companies and despite the deep controversy in the field over the existence of mania in children. What's being described here sounds to me more like hypomania than mania per se, except that hypomania, per the DSM, has to last for a week in adults.

How long should an episode of kiddie mania last to be considered mania?

"Using the investigators` criteria that require the presence of elation and grandiosity, a cycle of manic symptoms may be as short as 4 hours, with at least one cycle daily for 2 weeks defined as meeting DSM-IV criteria for mania."

And:

"Recommendation 2. The DSM-IV-TR Criteria, Including the Duration Criteria [i.e., 7 days], Should Be Followed When Making a Diagnosis of Mania or Hypomania in Children and Adolescents."

And:

"Recommendation 3. Bipolar Disorder NOS Should Be Used to Describe Youths With Manic Symptoms Lasting Hours to Less Than 4 Days or for Those With Chronic Manic-Like Symptoms Representing Their Baseline Level of Functioning."

So there you go folks. That's what the FDA considers pediatric bipolar disorder. I don't have much to say for now, but I'm interested in seeing your comments. If you are interested, the paper is here.

Posted by Philip Dawdy at September 22, 2008 12:05 AM
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Comments

They're not even trying. Bipolar means both, you can't have mania without the depression but depression is about being hard on yourself and mania is about being hard on others so who really cares when it's all about legitimizing social control. Behavioral health, Philip, get with the program.

Posted by: flawedplan at September 21, 2008 11:13 PM

The Harvard Bipolar Child Army has not won.

My daughter has.

Posted by: Stephany at September 21, 2008 11:14 PM

"...3. Individual psychotherapy. Based on studies of cognitive-behavioral therapy and interpersonal therapy in adults as well as clinical consensus of therapy with bipolar youths, individual psychotherapies support psychological development, skill building, and close monitoring of symptoms and progress..." (from the paper)

Erm, from this, I take it these studies of adults have revealed that they (the adults), lack certain skills, and "psychological development"? I would want to know who is making that assessment (and why they believe that these skills are relevant/necessary to a fully-functioning human being, and, for that matter, why these people believe that a given person lacks psychological development).

Anyway, back to the point. And it is this: if skills are learnt (and they are), then how has it come to be that these supposed bipolar sufferers lack these basic skills? Moreover, are we to take from this that bipolar is, in essence, a lack of basic social (ie, interpersonal) skills? On whose assessment?

Matt

Posted by: Matthew Holford at September 22, 2008 02:21 AM

Mental illness's are behaviours. To designate a behaviour as an illness is to judge the behaviour wrong. The behaviour may have been in humans from the dawn of man, as children mature. Chemical manipulation of the child-person does not teach the child how to become an adult.
I agree with Szasz as he says
"...Each belief is a manifestation of the adults' annoyance by certain ordinary childhood activities, their efforts to control or eliminate the activities to allay their own discomfort, and the medical profession's willingness to diagnose disturbing childhood behaviors, thus medicalizing and justifying the domestication of children by drugs defined as therapeutic.

Formerly, quacks had fake cures for real diseases; now, they claim to have real cures for fake diseases"

Posted by: mark p.s.2 at September 22, 2008 03:10 AM

Dear Philip:

By now we have pretty much established that the FDA is in the deep pocket of Big Pharmaceutical at extraordinary and unparalleled levels. So whatever data, diagnostic criteria, and evidence they are using to support any claim to their supreme egocentric diagnostic outcomes has to be viewed through the tainted lens of corruption, with great suspicion, and as erroneous in all reasonable measure. The fact is that these greedy SOB's want every child in America medicated in countless and immeasurable numbers just for being a normal developing kid.
We have seen time and time again the adverse effects the mental heath establishment has had on the care of adults with mental health disorders. Now in the name of pure and unadulterated greed they have decided it is to their greatest benefit in creating a market they can rope and dope with life altering medications from the cradle to the coffin. This is undoubtly big pharmaceuticals great marketing genius at its very best and worst; and a pure social travesty going beyond the bounds of criminal, and into the realm of intended unconscionable torture.
As we have learned and witnessed with much of the corruption and travesties incurred throughout corporate America, we all have paid for those crimes and greedy money grabs associated with these criminal activities, the fix rarely is even looked at until the horrendous damage has already been done.
Unfortunately in this case we are putting on the sacrificial alter the next generations of America. We have lost our moral, ethical road, and footing in the name of the all mighty dollar and profit margin. Without swift and decisive action we are the next great civilization to crumble from within. History is both are guide, warning signal, and witness to this cold stark reality. I have said this before, and will say this again and again, short of a bloody revolution the opportunity for a rational dialogue and reasonable change has gone and past now. It has really come down to our basic primal human instincts to stay afloat! The only question now is: will it be fight or flight?

You want to see the real life tragedy of our system? Go to SOULFUL SEPULCHER blog and look directly into those eyes of this child and victim; and please try to tell me we have done her justice with the heartless and criminal system we to endure day after day in American and around this world. Believe it or not, just because we are not the direct perpetrators of these crimes, this does not in any way take away our responsibility to act as moral and responsible citizens in each of our communities, and in this nation as a whole.
If there was ever a time to stop the infighting and bickering that goes on here; is there any more just a cause we can unite behind and make our voices heard from in deed and action?
Yours truly
Stan

Posted by: stan at September 22, 2008 06:30 AM

If only more kids had a Stephany. This means that boys who have temper tantrums are bipolar? That those kids who are abused will be labeled bipolar, or simply those kids whose parents spend little time with them and good luck to the 3 year old that tries to explain to a psychiatrist that he's being abused. Obviously if these drugs cause brain shrinkage in adults, at least the adult brain already got to mature, but children whose brains begin to shrink before they're even finished growing will likely have damaged brains but no one will attribute it to the drugs it'll all be blamed on bipolar disorder. This is horrible.

Posted by: Sally at September 22, 2008 07:28 AM

Philip, awesome post. If I could just point out a distinction. Classical Bipolar disease is still uncommon in adolescence. Its more of a young adults disease, the classical form. Of course the disorder could occur at any age, like almost any condition, but it is still uncommmon 12 and up. Part of the problem, is that by saying it isnt a problem for adolescents is that everyone is applying Biederman criteria to them also. And if they don't present with the "narrow phenotype" they will probably never develop the disorder. I guess my point is, the Biederman criteria are being applied to all age groups, adolescents, even adults (think Bipolar II). But obviously children can't protect themselves... so, thanks for a great post and great analysis.

peace

Posted by: JC at September 22, 2008 07:33 AM

I'd like to point out that this mania for drugging kids (a new market) isn't limited to mental health diasnoses. In my Sunday paper was an artfully placed little story about how doctors now want to test *8-year old kids* for cholesterol and put them on medication. At aged eight!!! My understanding of statins is that once you're on them you can't get off them. Sound familiar? A lifetime customer.

I found myself wondering if something's happened to our gene pool in the past twenty years of so. How is it that 8-year olds are now in such danger that you'd need to medicate them to prevent heart disease??? This cholesterol business is by no means settled in adults. The first line of attack is *supposed* to be diet and exercise. But my husband had to ask his doc to try that first (he was successful, by the way). If we really do have a sudden influx of kids in danger of heart attacks, the first thing to do would be to stop taking them to McDonald's, not drug them with pills.

Sheesh. 1984 has come--and stayed. At a time in which US society is perhaps its most "child centered", our children have become mere prey animals for corporate America. We are focusing on one part of the problem. It behooves us to remember this so we can seek out potential allies labouring in other areas.

Posted by: Sherry at September 22, 2008 08:39 AM

It all makes me feel terribly sad -- sad for the kids who are tagged as seriously mentally ill and placed on medications with disturbing negative side effects, sad for the parents who get suckered into this model because they feel desperate, sad for all of us because these kids who are now on long term medication will grow up., sad for what it means about us as a society that we are willing to allow this to happen to our kids. And glad that my kids are grown up. And that I no longer see children in my practice.

Posted by: Cheryl Fuller. PhD at September 22, 2008 09:17 AM

I take a more historical perspective on this bipolar diagnosis in children. First of all, children, especially boys, are naturally manic. They love to run, jump, skip and play and can be quite irritable when confined either by physical environments or psychological environments.

In the olden days, children worked very hard on farms, in factories and even in coal mines. They didn’t have time to be “manic” because they were too busy trying to survive and all their physical energies went toward this goal.

Even with the advent of the governments child protection laws regarding the workplace, these children were still required to work hard on the farm and, if they lived in towns, to have some kind of work after school [if they went to school] usually delivering newspapers, shoveling snow, cutting grass, working in their father’s store, etc.

Then in the 1920’s the U.S. began to see a good bit of affluence. This decade became known as the “Roaring Twenties” and people, because of the affluence, were allowed to act “goofy” up to a certain point. I suppose Al Capone would be diagnosed “bipolar” if he were alive and active today.

Skip a generation with the Great Depression & World War II and the next big period of affluence was the mid to late 1950’s. This produced the “beat” generation with Alan Ginsberg and Jack Kerouac of the book, “On the Road” published in 1957. This generation was inspired by jazz, poetry and drugs. I am pretty sure that the “beats” would be diagnosed as bipolar today.

Then in the 1970’s came the Vietnam War and the protesters. They turned to the illegal drugs and one of their more famous members, Abbie Hoffman of the Chicago Seven, later committed suicide on Prozac. I am sure that today he would be diagnosed as bipolar. His case is on www.SSRIstories.com

In the 1980’s with the advent of Prozac and masses of people taking antidepressants, the diagnosis of manic depression was changed to bipolar to accommodate the huge numbers of people going insane on the SSRIs. Doctors didn’t know what to do with these people so they were given the diagnosis of bipolar.

This caused the “trickle down” theory. If all these adults were now bipolar, then surely the children were also bipolar. Eric Harris of the Columbine school shooting was even diagnosed posthumously as bipolar. Three experts reported this in the Denver Post and it can be viewed at http://www.ssristories.com/show.php?item=190

This is my take on what is happening. It is truly a National Tragedy and will go down in history as one of the saddest periods in the history of psychiatry.


Posted by: Rosie C. at September 22, 2008 10:02 AM

AND A DISEASE IS BORN!
Thank you FDA, Harvard, Pharmas... and psychiatrists!

Where are the psychiatrists?
Those who are aware of what does it means to treat a child this way should be raising their voices!
Where are you?
Those who share their experiences in countless meetings supported by labs?
Are you going to stay quiet and silent as you use to do when a patient report a side-effect or a withdrawal effect?
Are you going to keep on receiving money as kols, ghostwriters and all the money you... blah blah blah...

All of you who are trying hard to drug children I have to say clearly because I cannot stand anymore seeing people suffering the hell because inadequacy of diagnosis and terrible side-effects, iatrogenic diseases, people committing suicide or homicide... all you know:

You belong to jail!

Yes, I'm angry and sad.
I have to express this because I can't take anymore feeling like crying because of the consequences of these people trying hard to drug a nation and the world.


Posted by: Ana at September 22, 2008 10:05 AM

Cheryl,

I just wanted to point readers here towards your blog. It's excellent.http://www.jung-at-heart.com/jung_at_heart/

Posted by: Sally at September 22, 2008 12:44 PM

I want to thank so many people here who have shown and given me support on behalf of my daughter. I am truly touched, and it lifts my spirits, beyond words.

I hope, by raising awareness by sharing her story, it can prevent at least one child from being injured wrongly on psych medications due to a wrong diagnosis or other reasons.

I applaud JC, who is the same age as my daughter, for speaking up and raising awareness, based on his/her experience that appears to be so similar to my daughter's. Yet, is able to communicate and talk about it.

Yes, Sally, Cheryl's site is a great one, and I appreciate her professional comments here too.

Posted by: Stephany at September 22, 2008 02:20 PM

I would like to thank the poster who pointed out that manic depression is a young adult onset condition. Both my children demonstrated full blown manic psychotic symptoms at the age of twenty, though there were some (unknown to me) earlier symptoms. Though I have received many arguments about this point, it is a highly genetic, heritable condition. For example, my father, my first cousin, my great aunt Fanny who ended up sticking her head in the oven. And thus it goes. If I were to meet Dr. Biederman, it would be as dangerous an encounter as would such a meeting with Mr. Lechleiter, CEO of Lilly. I would be very tempted to strangle them both.

The greed and meltdown going on now in our country will be and are affecting the Pharma Industry. I suspect rafts of jobs being off shored, while jobs in this country are being cut. Hard to know what the outcome of this will be. But those of us who care and who have suffered loss must never give up the fight.

Posted by: Sorrowful at September 22, 2008 09:27 PM

They are just making shit up at this point. Anything to cover their arses so it seems like they tried. They are just throwing words together into complete gibberish, essentially. Hamsters would do a better job. Plankton, even.

Posted by: Jordan at September 24, 2008 01:08 AM

I am extremely uncomfortable with the rapid cycling concept in the diagnosis of pediatric bipolar disorder. It can be applied to almost any mood or high energy activity and it’s a huge departure from prior diagnostic schemes. The process of diagnosing children ought to be held to very rigorous standards. I have worked with colleagues who adhere to that philosophy. But, I have also worked with psychiatrists who confide that they start medication based on their perception that the child’s behavior has the “flavor” of bipolar disorder. When I pressed for clarity, I have been told that such things as wearing unconventional clothing (btw, the sort of things on can buy at the mall at Hot Topics, we’re not talking psychotic displays here) or black nail polish or “the light in their eyes” were all evidence of pediatric/adolescent bipolar disorder. So, being moody or angry at your parents or at the healthcare providers is “evidence” of bipolar disorder. And without any further ado, these kids were placed on initial medication regimens involving multiple drugs such as mood stabilizers, atypical antipsychotics and then the “combos” were “tweaked” with various other psychopharm or antiseizure drugs AS IF we really know just what is needed and AS IF we really can precisely control what is happening at the level of subsets of neurotransmitter receptors. This is really an example of traveling faster than our headlights can illuminate. The state of the science does not warrant this practice.
I have seen severe, chronic and quite tragic manifestations of mental illness present in childhood. But I think that before labeling a child as suffering from a disabling psychiatric illness, one should be able to document over time a clear pattern of psychopathology AND either an EXTREMELY child-hostile environment or an extreme biological burden (strong family history of major psych disorder, which of course, may create that child-hostile environment). The existence of an alcoholic uncle, some dramatic dark poetry which upset the creative writing teacher, and screaming at your mother should not be sufficient. Again, careful observation over time might reveal a mood disorder which might be helped by treatment.
These medications have potent side effects and we have no long-term data regarding their effects on the developing brain. (Not to mention the 70 pound weight gain and onset of diabetes and lipid disorders …. Getting fat and having the chronic illness of middle age won’t do much for anyone’s self-esteem or social functioning). Before these drugs are used on kids at all, it would be nice to have some evidence of EFFICACY (sorely lacking for kids). And before any individual child or adolescent is diagnosed as bipolar and started on meds, it would be nice to have a clear diagnosis and sensible management plan (Have you noticed that drugs are almost never discontinued? A rational plan would call for evaluating for treatment plan efficacy and making a decision to change to something else. Most often the initial drugs are maintained and others added. This is irrational prescribing. The result is a patient on a completely irrational combination of meds. What are the target symptoms and what response did you expect from the med you chose? Now I’m ranting!

Posted by: psychRN at October 17, 2008 12:04 PM
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