Furious Seasons

August 14, 2008

FDA Psychiatry Chief Refuses To Address Questions About Pediatric Bipolar Disorder

Two weeks ago, the FDA announced that pediatric bipolar disorder--aka, child bipolar disorder, juvenile bipolar disorder, etc.--was a valid diagnosis, despite the fact that it doesn't exist in the DSM and child psychiatrists cannot even agree amongst themselves whether the disorder exists, whether it's a proxy term for something else, and what its exact symptomology might be much less its supposed pathology. The announcement occurred in an odd way--one of the inventors of child bipolar disorder, Harvard's Janet Wozniak, asserted in a letter to the editor of the Boston Globe that the FDA considered "pediatric bipolar disorder"--her term--a valid diagnosis. That was news to me, so I queried the FDA and was told that, why yes indeedy, the agency considered the diagnosis real. Despite approving two drugs (Risperdal and Abilify, both atypical antipsychotics) for the treatment of pediatric bipolar disorder in kids aged 10 to 17 in the last year, the agency had not taken any sort of public stance on the existence of the disorder in kids and teens. Now it has.

So, for the last two weeks, I've made repeated requests of the FDA to interview Thomas Laughren, director of the FDA's psychiatry products division. He was the official in whose name Sandy Walsh, an FDA spokeswoman, said the diagnosis was valid and I felt it was important for Laughren to come to the phone and answer some questions about the diangosis, what scientific criteria the FDA had used to determine the validity of same or was this just the opinion of some doctors at Harvard, and why Laughren had made this determination in the face of heated opposition from some credible figures in child psychiatry. In other words, my request was pretty straightforward journalism. Walsh and I traded some emails, but yesterday she told me by email--does the FDA not use phones?--that my request was being denied.

You see, according to an earlier email from Walsh, the FDA doesn't seen a controversy at all:

"It is the FDA's position that there may be some debate in the psychiatric community about the prevalence of pediatric bipolar disorder, but not about its validity as a diagnosis. As noted in our recent email exchange, the FDA does accept the validity of pediatric bipolar disorder."

This is simply crazy talk, as there is more than a little debate and disagreement within the psych world about the validity of the diagnosis. Last year, Jon McClellan of the University of Washington, said, they "can do the same diagnostic interview on 100 children and come up with five or 20 bipolar disorders, and I might do the same thing and find only one or none." Last year, McClellan also told KUOW-FM:

"Many kids have periods where they are quite irritable and they don't want to go to bed at night and they brag....[Classically,] they never would've been called manic. That changed in the last decade. Those kids are now being called manic."
Why?

"Well, that's a good question. Probably because some fairly influential research centers nationally decided that was the proper way to apply the diagnosis."

More pointedly, McClellan told me earlier this year that the kids and teens he was seeing (he sees some very intense kids and teens at two Seattle-area hospitals) who had been diagnosed with bipolar were in fact kids with oppositional defiance disorder and conduct disorder who were largely the product of extreme, and extremely dysfunctional, environments. The leader of the Harvard group, Joe Biederman, has said kids are born this way.

McClellan is far from the only one flying red flags around the bipolar child business. Steven Hyman, a Harvard psychiatrist and former NIMH head, has publicly expressed his concerns about the meds these kids are given: "We don't know the first thing about safety and efficacy of these drugs even by themselves in these young ages, let alone when they are mixed together."

In 2006, Thomas Insel, NIMH director, also pointed to the meds being given bipolar kiddos as being a concern, telling the New York Times, "There are not any good scientific data to support the widespread use of these medicines in children, particularly in young children where the scientific data are even more scarce."

In an op-ed, Larry Diller of UCSF noted: "Biederman shocked the child psychiatric world in 1996 by announcing that nearly a quarter of the children he was treating for attention deficit hyperactivity disorder also met his criteria for bipolar disorder. Up until then bipolar disorder was rarely diagnosed in teenagers and unheard of in prepubertal children. Biederman could justify his findings by simply broadening the semantic definitions of a previously more circumscribed condition contained within American psychiatry's bible -- the 'Diagnostic and Statistical Manual of Mental Disorders'."

So, yes, there would seem to be some controversy around the diagnosis and huge concerns around the meds kids are being given. In fact, I recently detailed just how dangerous some of these drugs have proven in real world, off-label use in children and teens. I certainly wanted to ask Laughren how he could approve meds to be used in children when there was such an uproar over the diagnosis--which adult psychiatrists I know shake their heads at--and when there was evidence that the meds aren't as safe as the approval trials for Risperdal and Abilify might suggest. Not that any of us can examine the pediatric bipolar disorder approval data for the two drugs since the FDA is currently in violation of federal public records disclosure laws because it hasn't posted the approval packages for these drugs in allegedly bipolar kids online. (In fact, the FDA's public database for various psych med approvals is rife with holes, ones I've already asked the FDA to fix.)

But more than the controversy itself, I wanted to ask Laughren what exactly pediatric bipolar disorder is and how it is defined. Does it start at 10? Or two? The term pediatric is so loose that it can apply--as if often does in medicine--to anyone over the age of a baby and under 18 (BTW, there is some consensus that bipolar disorder does exist in teens). What studies had Laughren used to determine the validity of the diagnosis? Why would the FDA have the power to unilaterally create a diagnosis that hasn't even passed muster with the makers of the DSM, that isn't even accepted by state insurance programs (bipolar kids are commonly coded as ADHD) much less private insurance providers. I wanted to ask him how much influence the Biederman/Harvard group had had on the FDA's finding and whether he had taken into account the views of others within child psychiatry on the issue.

I wanted to ask why the FDA has stayed mum on the validity of the disorder, because, if it truly exists, then wouldn't the FDA want to flag its existence for public health authorities so they can screen every kid in America? Wouldn't the FDA want to media to know so they could inform the public? Wouldn't the FDA want to contact NIMH and let them know? NIMH does consider bipolar disorder as a disorder that occurs in children, but ironically its web page listing symptoms of the disorder doesn't include any length of time for the persistence of symptoms the way the DSM does for adults. Since Laughren considers pediatric bipolar disorder the real deal, then he must have it all worked out whether the symptoms of "childhood mania" need to persist for 30 minutes or one week (as with adults) and whether signs of depression need to exist for, say, a day or two weeks (as with adults), and it would probably make sense for him to tell the world precisely what the hell he's talking about.

These are serious questions and they merit a serious response from the FDA. So far, that response is absent.

Well, there's got to be a reason the FDA is avoiding questions. Maybe a major media outlet hasn't called them yet (bureaucrats always get back to the New York Times. Freelancers? Not so much). Maybe the FDA is scared of bad publicity, although after the salmonella scandal I'm sure its skin is fairly thick.

But maybe there's a different reason. I think there is. I'll get into it in a subsequent post, possibly later today or tomorrow.

Stay tuned.

Posted by Philip Dawdy at August 14, 2008 12:03 AM

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Comments

Phil,

Could you request a meeting with them?

It's took me a hell of a long time to meet with the MHRA but I have that meeting now, mind you for all their failings the MHRA do seem more approachable than the FDA.

Fid

Posted by: BOB FIDDAMAN at August 14, 2008 12:09 AM

Philip,

Here are a few quick reactions to your important post.

First, the FDA has no business passing judgment on the validity or otherwise of pediatric bipolar disorder. We need to observe a bright line here. The FDA is authorized by Congress to regulate the claims of pharmaceutical manufacturers and marketers as to the efficacy and safety of products. The FDA has no authority to regulate the practice of medicine. So, if the FDA has indeed announced that pediatric bipolar disorder is a valid diagnosis then the agency is overstepping its mandate.

Second, the FDA has no mandate to oversee the prescribing practices of individual medical practitioners. That is why so-called off-label use of medications is so common. That discretionary use of medications by individual practitioners is an important professional privilege that we should not abridge. Only state medical licensing boards have the authority to discipline physicians for their prescribing practices. Clinicians will rightly continue to use drugs off-label because they know that FDA- approved indications for a drug are not the whole story.

Third, areas of controversy are common in medicine. That is consistent with our need for epistemologic humility. We are not omniscient and sometimes we do not even possess the knowledge to frame the really incisive questions. Medicine is a pragmatic profession that does the best it can when faced with an imperfect knowledge base.

Fourth, it is true that commercial interests exploit the weaknesses of our medical science. Commercial interests have become skilled at promoting off-label drug use and at manipulating the agenda in drug development. The world does not need commercially sponsored trials of Risperdal (risperidone) and Abilify (aripiprazole) in youth with bipolar diagnoses. Under the hypocritical cloak of “unmet need” these are nothing more than experimercials designed to expand the market for Janssen and Bristol Myers Squibb/Otsuka. What is needed is an independent clinical research program on youth who are given the diagnosis of bipolar disorder. A medication trial would be only one component of such a research program. An essential component would be longitudinal follow-up, which is conspicuously lacking in commercial clinical trials.

Finally, we need to cease and desist from the Pharma-driven practice of conflating the clinical trial outcome that a drug is “better than placebo” with the inference that the drug is recommended for clinical use. In the case of Risperdal and Abilify, there are data that children who receive these agents have a palpable risk of tardive dyskinesia with as little as 6 months treatment. The trials that the FDA relied on for their approval of these agents in so-called bipolar youth were not powered to detect this problem. It seems to me the FDA took a sucker punch here and they need to reconsider their approvals of Risperdal and Abilify.

Posted by: Bernard Carroll at August 14, 2008 02:51 AM

Thomas Laughren is associate with pharma, ghostwriting and in my opinion the FDA's promotion of pediatric bipolar disorder is proof that they are as corrupt and the rest of this industry, and highly influenced by Harvard et al.

The safety of children is at stake concerning these drugs and if the FDA fell into the trap of the Biederman Harvard Mafia influence, then there is NO HOPE AND PARENTS SHOULD BE WARNED.

Posted by: Stephany at August 14, 2008 09:56 AM

Bernard,

This sounds well and fine. However, history is replete with examples of the failure of self policing whether it be doctors, lawyers, or police forces.

A few comments in response.

Until "Medicine" reigns in "Psychiatry" and holds it to the same standards as the rest of Medicine, the problem will continue to worsen. Psychiatry must produce validated, objective tests that identify and specify these so-called diseases before it should be allowed to experiment on people with drugs. The serotonin hypothesis has been proven bankrupt, and now they're on to the next pharma product de jour. Surely, this is not medicine, but marketing, no?

I don't think off-label use of psychotropics can be justified today. The privilege to prescribe off-label has been surrendered due to chronic abuse by Psychiatry. The approved uses are already specious and unconvincing. I'd put a black box warning on every psychotropic until a minimum of 20 years of safety data were available to warrant further reconsideration.

Now, even if you could fix the Psychiatry industry, rectifying the drug approval process is equally daunting.

Firstly, all studies, not the the cherry picked successes, need to be included in the submission package.

Secondly, studies must include active placebos and stricter accounting during placebo washout - too many funny games played here.

Objective measurement of efficacy must be demonstrable (good luck).

Validated withdrawal/discontinuation protocols must be included in the submission package.

Long-term studies need to be conducted to monitor patients well beyond the treatment phase.

Thirdly, labeling needs a major overhaul.

Off-label use must not be permitted without a sanctioned experimental protocol, a signed patient ICD, IRB approval, and approval from the regulators. Experimental (off-label) use should be treated no differently than a clinical protocol. Criminal sanctions for violations and automatic loss of professional license.

The label must disallow non-voluntary use - this might necessarily preclude minors.

The label must also include the requirement for the use of a (existing) diagnostic tests that objectively specifies the disease and thus the requisite treatment protocol.

All of this means psychiatrists will have to work really hard to help people in crisis. They won't be able to just sedate them, lock them up, and simply lie to them regarding their diagnosis, prognosis, and treatment options. They can't just say what they want - they'll have to back it up with real diagnostic tests. If not, they'll be criminally liable, as they ought be.

Too bad it ain't gonna happen. Doctors won't police psychiatrists, neither will licensing boards - it's the same group of people from the same country club. The FDA is hapless or deliberately obtuse.

I've said before the pile of dead and maimed is not yet high enough for the kind of change that is necessary.

Posted by: Paul at August 14, 2008 10:42 AM

"The leader of the Harvard group, Joe Biederman, has said kids are born this way."

This is exactly the party line in my extremely dysfunctional and abusive family. It has been used for generations to cover up the abuse, to explain away its symptoms and to discredit the victims.

Who knew we were so far ahead of the curve? Or in such distinguished company? Harvard... Imagine that!

Posted by: Sherry at August 14, 2008 11:28 AM

Quick show of hands:

How many people on this forum who have kids have experienced a kid being irritable or not wanting to go to bed?

Perhaps more importantly, how many posters on this forum engaged in such behavior as children?

NO kid wants to go to bed and EVERYONE has periods when they're irritable. I'm sick of these constant efforts to transform normal human behavior into a pathology.

Posted by: Puckett at August 14, 2008 12:18 PM

Paul, you have stated twice that the "pile of dead and maimed" is not high enough yet for the lethal and greedy psychiatric drug game to be cleaned up. But what about criminal trials against those in Pharma (and perhaps in the FDA as well) as a method of behavior change? The lawyers I've talked to suggest second degree murder or manslaughter if someone is killed by a drug that the company knows has unrevealed lethal side effects.

Back to Laughren: If you have ever observed him suffering through a public hearing, praying for it to be over, you would know you are dealing with a dead fish. Prayers that he will be canned immediately, along with Dr. Temple, if Obama wins the White House.

Posted by: Sorrowful at August 14, 2008 12:18 PM

Puckett, I love you. You got it.

I met a well meaning social worker last year while I was advocating, and she was convinced a new client of hers, a 6 month old baby was bipolar and was grinding an SSRI in the baby's bottle of formula. I am happy to report I kept cool though in the back of my mind I wanted to scream.

Last week I was watching cartoons with a friend of mine and her baby. "Adults ruin everything, kids are being kids", Timmy Turner, on Nick's Fairly Oddparents. I liked that quote so much I had to write it down ASAP, least I forget it.

For shame. Six month old babies are not bipolar. They are babies. That is what babies do.

I wonder why the Papolouses are so quiet on this one.

thanks Philip for breaking it before the mainstream media did..

Posted by: susan at August 14, 2008 01:48 PM

Unfortunately, Obama is a also big friend of Pharma, having at last count topped the list of all candidates in Big Pharma contributions.

Plus, he co-sponsored the MOTHERS Act, which sought to screen all pregnant women for mental illness. Fortunately, the bill was recently voted down (for now, that is).

Posted by: Tony at August 14, 2008 02:05 PM

Tony, it is true that Obama has taken a lot of cash from Pharma (Hilary was second) and that they both co-sponsored the Mother's Act. But there is no hope with Bush, and hasn't been for eight years as he gutted every agency in the executive branch so as to favor industry. Until I see negative evidence, I have to have some hope for Obama.

Posted by: Sorrowful at August 14, 2008 02:43 PM

It would be interesting to do a study about how many children of psychiatrists are diagnosed with mental disorders? How many of their children are on meds? Would they brand and tar their own children's lives with the stigmas of Bi-polar, ADHD or Psychosis?
Would they put their own kids on these drugs?
I would love to know the answer to that..

Posted by: truthman30 at August 14, 2008 02:53 PM

Sorrowful,

Lawyers serve the law, not justice. Fortunately, medicine and law are congenital opponents.

IANAL, but a criminal judgment might provide some much needed traction. It's exceedingly difficult to find a corporation guilty in criminal court. It's more likely some mediated settlement (with no admission of wrong doing) will result and thus the status quo is maintained. I don't see the Psychiatry Industry being corrected in this way, however. It will take a collective social uprising to fix this. Psychiatry is too enmeshed in the law, in pop culture, and people are, frankly, too stupid and ignorant to recognize an evil that stands in front of them as long as money is put in their pocket.

Posted by: Paul at August 14, 2008 06:49 PM

Actually, there is absolutely nothing in the DSM criteria for any of the bipolar disorders (I, II, cyclothymia, due to a medical condition or substance, or NOS) that requires the individual to be of a certain age in order to receive a bipolar diagnosis. The criteria related to symptom duration aren't restricted by the individual's age, either.

At a most basic level, a diagnosis is a label used to facilitate communication. There isn't an ICD-9 code (the numeric codes used primarily for billing purposes) for "pediatric bipolar disorder," nor is there an ICD-9 code for "adult bipolar disorder"; neither of these is actually a diagnostic entity.

NB: this isn't to say that some people (adults and children alike) are being incorrectly diagnosed.

Posted by: Gerbil at August 14, 2008 07:30 PM

Judith and Joe are soul less bipolar fascists interested only in making soul less zombies that placidly eat pills forever. That's it.

I saw this post last night because I was burning the midnight oil along with Philip it seems but my brain was too fried from writing all day to comment then.

There is few things in this world that have to the power to get me so angry I can not think straight and this fake childhood bipolar is pretty much the biggest one.

When I saw this post I was going off to bed and I knew if I replied last night it would be all caps with many curses.

There are several layers of cruelty, malpractice and tragedy going on here.

The first is diagnosing an unproven disease which has no cure in children before they have had time enough to grow a brain complicated enough for thought and mood disorders.

To say such a thing has no cure when people are beating this illness left and right is deceitful.

Under these false premises you can make a claim that these kids just need to get on this drugs for the rest of their life the sooner the better.

The problem with that is that antipsychotics have been proven to cause frontal lobe damage over time. Far from being just a trivial med these drugs prevent learning, maturity and true healing while potentially causing a myriad of other iatrogenic illnesses.

All for what, a disease that turns out not to be incurable? What then?

Let me give some perspective here.

I was Dxd as a young teen with bipolar. The fact that I came from horrendous physical and mental abuse was immaterial. I was presenting suicidal depression and psychotic mania so I was bipolar period. This was no outpatient Dx, a single opinion. This was the consensus diagnosis of an entire inpatient treatment team.

So I was force medicated against my will for this crime at age 14. My symptoms did not materialize out of thin air at 14. I had had suicidal depression at age 7 and manic episodes at age 10. In other words my symptoms presented as a child.

The reality is I was an above average intelligent artist after my mother's own sensitive temperament. I lived in fear and stress in a violent and abusive home for years.

Not only did I carry depression at a young age I had oppositional and even sociopathic behaviors modeled directly after my mother and step fathers behavior as a teen and preteen.

I could lay a claim that my teen bipolar was merely an extension of the earlier symptoms thus putting me in the realm of child bipolar.

However the treatment I received to *help* me did much harm and no good. I was sensitive to my body and to chemical effects and I remember the soul killing nightmare of going on antipsychotics and later lithium.

I became eventually so distraught while on meds because of the med effects and because I was not allowed to refuse this punishment I nearly killed myself on the ward.

Only at the last second as I setting myself up to hang did I realize that the drugs and the mental health environs were causing me to kill myself because of a perceived inability to escape or be free of it. Teens are impulsive. I did not see any other way out except to die.

At the last second I aborted and I abused my structured privilege the next day to flee the facility for dear life.

Once my mind cleared up as the drug half life expired my lights came back on and I realized I had been living in an enchanted foggy nightmare of delayed thinking and dronehood.

I realized I was being mind wiped long before I ever hear the term chemical lobotomy. I could sense it. I did not have the uniquely adult way of bullshitting myself that this was *therapy*

Unfortunately for the staff, my keepers and my social worker I had learned that at the age of 15 I had the legal right to refuse consent to medical treatment.

My court appointed guardian ad litem filed a writ of habeas corpus on my behalf and I went up against my state appointed social worker in court who insisted to the drug that I be forced back on meds immediately.

I then explained to the judge that yes, I had had some rough times growing up. Harder then some, but not as hard as other. Yes I had some depression and mood swings. But then I pleaded, what teenager does not have mood swings? How you would feel if you were threatened every day and never felt safe? I told him it was a developing phase and that I was over the worst of it and no longer needed this level of supervision. I told the meds had hurt me and I refused to take them because it had done nothing to solve my problems whatsoever.

The judge agreed and forced my social worker to remove from placement and I did not have to go back on drugs.

For years I have wondered how I could use my life experience to benefit others. Now I know. I can write about it and it put myself on camera and tell people this childhood bipolar is a lie. It is a pseudoscientific myth. It was possible for me to learn to control manic symptoms and depression symptoms without meds as a teen. It was the mental health conundrum similar to putting a gun to my head and saying "Stop being bipolar or I will shoot you".

Given that I was never going to be released or allowed to stay off drugs I trained myself day by day to mask the simple things that were called mania like my fidgeting.

I learned to calm my own racing thoughts because my rapid speech and flight of ideas, natural for an intelligent, passionate teen was threatening to adults and wrongfully attributed to an unproven brain disorder.

In short, I learned to fake it until I was an adult. I learned to hide my problems from the world. That was the real lesson there. What we expect from each other in the workplace and professional world. Don't you come to the office or school with mental health issues!

Later I cured myself of bipolar the same way everyone else is these days. Slowing down my life, clean, healthy balanced lifestyle. Plenty of personal time to destress, avoiding things that would make me cycle from one state to another.

Meditation in particular helped in this regard. Meditation is scientifically proven to increase brain density. Specifically, meditation engages the ongoing neuroplasticity in adults to develop the prefrontal cortex. The area of the brain well know for emotional and cognitive processing.

So I have been depression free for over ten years and mania free for barely less all thanks to taking personal responsibility for my mental and emotional states.

I can say that this child bipolar is a lie. It is a public concern because it is malpractice against the helpless. It is fraudulent and irresponsible beyond the pale to suggest such a disease exists when other more mundane reasons such as normal development or family stress may be behind certain behavioral phases in children.

The fact that these kids can not say no is what breaks my heart. That mommy and daddy are going to say to their kid to be good and make them proud and take Joe and Judith's meds because it's going to make everything all better.

Well it's not going to make it all better. All the parents may have a quieter, more lethargic, more apathetic child that requires less attention. That does not mean that is for the best.

When these kids grow up and find out they did not have a lifelong incurable disease and that they have been forced to become addicted to central nervous system damaging drugs for years these kids are going to have questions and they are going to demands answers and compensation.

We will be facing an epidemic of willful malpractice and iatrogenesis that will have further costs to society for decades to come.

Those victims of the bipolar paradigm will want answers and they will have need to be answered.

Right now our answer to them is because Joe and Judith said so.

Joe and Judith said so because it was profitable for them to do so.

Posted by: Jane Alexander at August 14, 2008 08:52 PM

Jane,

I firmly believe you from my heart. How do we fix this? How do we blunt the influence of Joe, Judith, and the other in medicine and Psychiatry?

I wish I had a comforting answer.

Posted by: Paul at August 14, 2008 09:37 PM

This is simply crazy talk, as there is more than a little debate and disagreement within the psych world about the validity of the diagnosis.

I recently detailed just how dangerous some of these drugs have proven in real world, off-label use in children and teens.

These are serious questions and they merit a serious response from the FDA. So far, that response is absent.

This crazy talk is not known by many people in real world.
In US, UK and other countries.
I've just heard, down here this argument while talking about side effects:

"-But the FDA don't leave these dangerous drugs on the market."

FDA behave like this and know that people get in touch with the "reality" of side effects and the dangerous of these drugs after being on them.
By not talking serious FDA not only is of great help not to change anything and create more and more confusion.

This is a shame to say the least.

Posted by: Ana at August 14, 2008 11:48 PM

It's just breaking, but the Boston Globe is reporting that Yolanda's law is advancing.

My heart breaks for both Yolanda and her mother.

I wonder if the people you mentioned in your piece have anything to say to Yolanda's mother. I am sure it's not much. Yolanda deserved better.

Posted by: susan at August 15, 2008 01:41 PM