September 16, 2008

The FDA (Finally) Responds (Sort Of) To Questions About Pediatric Bipolar Disorder

Yesterday, just as I was about to fax the agency a FOIA request in response to the FDA's continued silence on defining pediatric bipolar disorder, I got an email from Sandy Walsh, a press officer at the agency, stating the following:

"The FDA does accept the validity of pediatric bipolar disorder. The FDA agrees with peer-reviewed journal articles, academics and clinicians that say that pediatric bipolar disorder can occur in children and adolescents and is a serious, chronic illness which causes shifts in a person's mood, energy, and ability to function.

"Understanding the effects of bipolar disorder early in life may lead to better treatments and improve long-term outcomes as children and adolescents become adults. The FDA, a science-based agency, puts a priority on children's health and believes it is important to study medicines and diseases in pediatric patients.

"According to the National Institute of Mental Health: Research findings, clinical experience, and family accounts provide substantial evidence that bipolar disorder, also called manic-depressive illness, can occur in children and adolescents. Bipolar disorder is difficult to recognize and diagnose in youth, however, because it does not fit precisely the symptom criteria established for adults, and because its symptoms can resemble or co-occur with those of other common childhood-onset mental disorders. In addition, symptoms of bipolar disorder may be initially mistaken for normal emotions and behaviors of children and adolescents. But unlike normal mood changes, bipolar disorder significantly impairs functioning in school, with peers, and at home with family. More information about symptoms can be found here: http://www.nimh.nih.gov/health/publications/child-and-adolescent-bipolar-disorder/summary.shtml

"Emerging evidence from pediatric bipolar research suggests that various phenotypic presentations are manifest in children with pediatric bipolar disorder. Based on the interpretation of the DSM-IV TR criteria, the current literature appears to support two phenotypic presentations of pediatric bipolar disorder: a "narrow" phenotypic presentation that manifests with classic mania symptoms and a "broad" phenotype. Regardless of the phenotypic presentation, however, all diagnoses of pediatric bipolar disorder used in the pediatric bipolar clinical trials for Abilify and Risperdal were made using the current DSM-IV TR criteria. The FDA expects that the next edition of the DSM, DSM-V, will address issues over pediatric bipolar phenotypes.

"The FDA notes that different phenotypic presentations of illness is not unique to the field of psychiatry and in fact have been described for other medical disorders such as the inherited connective tissue disease called Marfan Syndrome (Loeys B et al "Genotype and Phenotype Analysis of 171 Patients Referred for Molecular Study of the Fibrillin-1 Gene FBN1 Because of Suspected Marfan Syndrome" Arch Intern. Med 2001; 161:2447-2454)

"The FDA makes decisions to approve medicines based on science and clinical evidence. In the cases of the approvals of Risperdal and Abilify to treat symptoms of bipolar I disorder in children, the data show that the patients taking drug therapy had fewer symptoms of their illness. The pediatric studies of Risperdal and Abilify provided an opportunity to assess the effectiveness, proper dose, and safety of using these products in the pediatric population.

"The FDA thinks evaluating the diagnosis of and response to therapy in a controlled study situation where information will be systematically recorded and evaluated is far superior to having children exposed to unknown doses in a continous uncontrolled process. The latter is what happens when products are used in children because they are available for adults but never evaluated in a population which is know to also have the disease.

"Also helpful in explaining pediatric bipolar disorder is a 2006 study from the National Institute on Mental Health, available at [here] and the American Academy of Child and Adolescent Psychiatry's guideline, Practice Parameter for the Assessment and Treatment of Children and Adolescents With Bipolar Disorder (attached)."

That AACAP guideline is right here. I've been reading it and will comment on it later, since it's hardly what one might consider a DSM kind of definition of pediatric bipolar disorder.

After almost two months of pushing the agency to define a disorder it accepts as valid in the face of controversy within (and without) child psychiatry, I don't know what finally pushed the FDA's button. But I'm sure that the emails many of you sent to the agency last week certainly helped. I thank you all for writing the agency and helping to force the issue.

I'll have more on this later today.

Posted by Philip Dawdy at September 16, 2008 12:03 AM
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Comments

The FDA has based their validity on approvals for Risperdal and Abilify and those approvals does not validate calling an illness or disorder "real" in my opinion. I feel it is wild loss of common sense, and the government should not base a dx that is NOT in the DSM for kids, on Biederman and Wozniak's trial for example, done on 5 yr olds in 1999 for Risperdal.

I stand by my thoughts on this, that Laughren was influenced by a KOL and it's Biederman, and the rest that have led this dx down the path straight to the approval from the FDA they wanted for those drugs for kids.

It is Thomas Laughren who was at a pharma-funded work study group with CABF (a highly influential parent of "bp kids" website, where ALL of the ppl ever mentioned sat or sit on the professional advisory committee there, and Laughren himself needs to respond, not some PR person.

I ran across a memo he wrote in 2007 saying that Lilly provided enough good evidence to approve Zyprexa for teens with bipolar....again he is signing approval papers as if this dx exists.

There's a reason it exists. Pharma-funded KOL leaders studies are why.

I'm so glad he seems to have forgotten Zyprexa is fully loaded with lawsuits, has one of the worst histories of an antipsychotic on the market, Lilly HID data about the diabetes risk (that was hidden in those documents that could have prevented Ellen's son from dying and could have prevented my daughter from years of enormous weight gain and more at age 11).

I find this deplorable. The FDA is worthless with regard to safety of children's health if for one minute they think recommending Abilify and Risperdal is good for children.

Since when is treatment for bipolar disorder done with antipsychotics? even at the minimum, why are they not talking mood stabilizers? instead they are already buying into pharma's marketing plan of mainstreaming antipsychotics for general use.

I saw what my daughter looked like on Risperdal in 1999 and so did her teachers at school, which prompted a meeting and exact words were "what the hell is wrong with her?"

I look back at that 6th grade photo and am shocked at how drugged up she looked.

I feel the FDA has made a grave error here, and parents will not know at all what they are doing by using FDA standard approved drugs and dx's.

Imagine, 9 years ago I watched this all unfold and these drugs were not approved yet, and you know what people? they still are dangerous, life-altering, and damaging to a growing child's body and brain, and the FDA says they are safe based on NO EVIDENCE of long-term use in kids!!

WTF!

Posted by: Stephany at September 16, 2008 01:32 AM

Well, you've got a bunch of highly-paid "experts," whose very position in society is dependent upon the existence of this, and other, mental disorders. You've got a whole industry, which makes a great deal (if not the majority), of its money from the "fact" that it has the most widely recognized (officially), therapy for this disorder. And you've got the fact that they've been saying this for a long time, irrespective of whether they've been saying it because they believed it to be true, or because they had an interest (financial or otherwise), in saying it.

Now, you're Joe B.D Mann. You're feted by what passes in our age as some important people. You're telling the drug industry what it wants to hear, and you're being financially rewarded for it. Your entire reality is founded upon bipolar being real, and diagnosable, and then treatable with drugs.

What if even one of those three things wasn't true? You'd be fucked, wouldn't you? Your expertise would be out of the window, along with any residual credibility.

Small wonder, then, that everybody refuses to budge - they can't even acknowledge the merest possibility that they've got it wrong, because that would require that they scrutinize the very system that a lot of people are claiming has caused them more harm than good, in order to find out where they got it wrong, when the truth is, there are a lot of people making a lot of money out of the current system, wrong or right. Let's face it: there's not much motivation, there, for anybody to do anything but carry on - except those who aren't profiting, of course: they're highly motivated.

Matt

Posted by: Matthew Holford at September 16, 2008 03:50 AM

"Understanding the effects of bipolar disorder early in life may lead to better treatments and improve long-term outcomes as children and adolescents become adults.
It sounds so DSM-5! What does it mean?
I would love if the effects of bipolar disorder in early life was possible. It's already hard to understand these effect in adults. I'm confused.

Dear Mrs Walsh,
Thank you for the reply.
But I have the same doubts I had before reading your answer.
I fear I'm even more confused with all these informations copied from different institutions.
Thank you anyway.


Posted by: Ana at September 16, 2008 07:02 AM

Hi Philip,

When the FDA receives enough pressure from the general public, they sometimes respond. I sent your FS post about contacting the FDA to my Message Board [51 people] and a person on that Message Board sent it to his Message Board [over 100 people ] and who knows who carried it on from there.

When I received my reply from JoAnn Minor of the FDA, I knew that the FDA had had an overwhelming response,-- thanks to Furious Seasons, its readers and all the other activists.

It was the same at the Feb. 2nd, 2004 FDA Meeting on Antidepressants, Youth and Suicidality. So many parents showed up for this meeting that the FDA [which was suppressing the work of their own FDA reviewer on the subject, Dr. Andrew Mosholder,] was forced to do the Columbia U. study which did show a 2 to 3 times increase in suicidal thoughts and behaviors in children on the drugs as compared to placebo. With so many parents in attendance and so many news broadcasts reporting what these parents testified, the FDA would have had “egg on their face” if they hadn’t responded. So at the Sept, 2004 meeting the Black Box warning was approved due to the data from the Columbia study.

We must never underestimate the power of individuals to be effective when approaching a government agency.

Since I have a pathological fear of flying, I was forced to drive to Washington, D.C. in Feb. 2004. It was a two day trip that took 25 hours. All of the way I was thinking, “Is this trip worth it? Won’t they just ignore us?”

I was in contact by phone during this trip with a woman who was driving 36 hours because, although she is not afraid of flying, she was taking with her a mom whose 12 year old daughter had committed suicide on Paxil and also a 19 year old boy who had been shot and barely survived an attack on him by a person who was under the influence of the SSRI antidepressant Luvox.

I met many warm, kind dedicated parents at that FDA Meeting. They were truly an inspiration.

Through contacts at that meeting, www.SSRIstories.com was born. According to Statcounter, it has received 196,058 hits since Statcounter began recording on Jan. 1st 2008. This statistic includes the Individual Stories.

Of course, now Pharma and some of the docs [there are many forms of evil] are saying that the Black Box warning caused an increase in suicide among youth.. They did have the wrong years, though, - 2003 and 2004, and the wrong data. They forgot, too, that people who attended the 2004 FDA Meetings heard them say that there was still an increase in antidepressant use among youth.

See: http://www.ssristories.com/show.php?item=2036 This Website from the American Psychiatric Association still works and it shows that the statistics said that there was an 8% increase in antidepressant use among youth in 2004. It was not until 2005 that antidepressant use began to show a decrease and, then, this produced a drop in suicides.

There are now 47 school shootings on www.SSRIstories.com and, yes, Cho was probably on antidepressants also as the Blacksburg, VA newspaper for that day stated that police were carrying out Cho’s computer because it appeared that there was data on his computer showing that he was taking antidepressants. Also, his medical records from the University Health Center went missing and, too, it was never revealed what medication Cho took that morning [which was reported by his roommate and published in the New York Times]. As I said, there are many forms of evil.

The UNI school shooting, which involved a three week Prozac withdrawal, was our most recent school shooting. Of course everyone who had ever belonged to the Prozac Survivors Support Group knew what this meant. People had reported thoughts of homicide for up to a year after withdrawing from Prozac.

This giving of these dangerous atypical antipsychotics, especially Zyprexa, for a diagnosis of so called pediatric bipolar disorder is beyond tragic. It is another form of evil. So, we must all carry on and not let them “get away with this”.

Posted by: Rosie C. at September 16, 2008 07:03 AM

For some reason, the Individual Story on the increase in antidepressant use among youth in 2004 will not open.

I think I have it now. Try this.

http://www.ssristories.com/show.php?item=2036

Posted by: Rosie C. at September 16, 2008 07:26 AM

That meeting in 2004 almost didn't happen...because so many people had signed up and there was so much press, the FDA tried to make all of us draw straws as to who could speak. They failed.

What I see from the FDA, in response to this pressure, is a classic cut-and-paste job. How pathetic. I suspect that the scientists within the FDA who know anything about this managed to steer clear rather than lie or fudge.

As far as giving Zyprexa and other atypical antipsychotics to teens and children for this fake disorder, the plan has always been to push to high price atypicals. I doubt you could barely find a kid on lithium (not perfect but doesn't kill people and actually works a lot of the time) who has been given this label. It is the drug of choice for manic depression. But even with adults, especially those on Medicaid like my son was, the push has been and is to give the patented atypicals. Evidence that they work? What I read is that many parents take their kids off due to the side effects like milk coming from the breasts of boys.

The FDA is a joke. Here's hoping that if we get Obama there'll be some changes made. It didn't used to be as gross as it is before Bush came in. Waxman has done studies to prove this...of course if one of your best friends is Syd Taurel of Lilly, as president you will go out of your way to favor this lethal industry.

Posted by: Sorrowful at September 16, 2008 12:28 PM

I too received this response from the FDA. It's discouraging and odd.

Here's a bit I don't get:"Bipolar disorder is difficult to recognize and diagnose in youth, however, because it does not fit precisely the symptom criteria established for adults..."

As others have noted, the very fact that by definition bipolar disorder in children is different from bipolar disorder in adults makes me wonder why it is being called bipolar disorder at all.

Posted by: Sally at September 16, 2008 01:05 PM

Sally wrote:
"Here's a bit I don't get:"Bipolar disorder is difficult to recognize and diagnose in youth, however, because it does not fit precisely the symptom criteria established for adults...""

I'll translate that for you:

"Only very skilled people, such as Joe Beady-Mann, can possibly pick through the malaise, and identify the thing that is making one's child behave in a way that one (and possibly others), doesn't like. It's different to adult stuff, because we're dealing with kids, which just goes to show how complex this is, and how impressive we are for figuring it all out, and then making the difficult choice of which drug to prescribe.

"You want to know how Jo Binderman does it, when the complexity of it all would cause any normal human mind to implode, and yet retain his sanity completely, despite the fact that he's delving into depths of human behaviour never plumbed, before? I'm afraid that can't be allowed, because Joe Boodlemon is incredibly important, and isn't able to sacrifice his valuable time for nobodies, not even his peers."

Put another way: "we make the rules, and we're not letting on what the rules are, because if we did that, you'd be able to scrutinize us altogether more effectively."

As an afterthought, what do you imagine it would be like, trying to gainsay Boodleman's paradigm? Imagine you found yourself on his team at Harvard, and you found fault with his approach? You'd be asked to make sure that the door didn't hit your arse, on the way out, probably. I reckon Bindermann's surrounded himself with clones of himself.

Matt

Posted by: Matthew Holford at September 16, 2008 03:47 PM
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