July 30, 2008

FDA Says Pediatric Bipolar Disorder Is Valid

Earlier today, I asked the FDA to respond to a statement made by Harvard child psychiatrist Janet Wozniak, wherein the doctor claimed that the FDA accepted the validity of the hotly-debated child bipolar disorder. That was news to me, since the diagnosis does not exist in the DSM and many child psychiatrists such as Jack McClellan and Larry Diller, both affiliated with major medical schools, even claim that the child bipolar diagnosis is not real.

From FDA spokeswoman Sandy Walsh comes the following reply:

"I just heard from Dr. Tom Laughren, head of psychiatry products. He said that Dr. Wozniak is correct. The FDA does accept the validity of pediatric bipolar disorder, as evidenced by our issuing Written Requests for pediatric studies for this disorder and approving both Risperdal and Abilify for use in pediatric bipolar disorder."

I'll likely be talking with Laughgren in the next few days so he can explain how it is that a disorder that doesn't exist in the DSM and doesn't exist in the minds of experts in the field actually can exist in the minds of the FDA.

Stay tuned.

Posted by Philip Dawdy at July 30, 2008 02:07 PM
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Comments

"-Explain to me as if I was a 6 years old child."
What does FDA has to do with the "validation" of a disease?
Is it it's job to claim what is a disease, who has a disease or not?
:o)

Posted by: Ana at July 30, 2008 02:44 PM

It would be interesting to find out what David J. Kupfer, the person in charge of the DSM V thinks about this topic and if the Pediatric Bipolar Disorder will be added to the new book.

Posted by: susan at July 30, 2008 04:04 PM

Phil, it only exists because there are drugs for it mate!


Fid

Posted by: BOB FIDDAMAN at July 30, 2008 04:21 PM

Look at all the other phony conditions in the DSM.And of course the FDA will say it is real. They are on the payroll. Happy to see today (Pharmalot) that Dingell and Grassley are out to change the FDA.

Posted by: sorrowful at July 30, 2008 04:56 PM

If these drugs are going to be approved for children, isn't it about time that long term studies of their safety are undertaken?
A kid taking an anti-psychotic for basically his whole life because he is told he has a permanent psychiatric disorder is prone to many of the side effects of these drugs.
So basically, this plays out that if a child has temper tantrums because he didnt get that new videogame or acts out in class, he will be diagnosed as bipolar and take these drugs for life?
so much for free will and all....

Posted by: Thomas P at July 30, 2008 06:28 PM

Philip,

Thanks for calling the FDA. Interesting that they are now in the business of validating whether or not certain diseases exist. I thought they were the "WATCHDOG" for the American public in regard to "FOOD & DRUGS".

Well, a person learns something new every day.

Posted by: Rosie C. at July 30, 2008 06:58 PM

The FDA has just made a hideous decision that is nothing less than a criminal assault on the children of America.

There is no base for this decision, except wild abandonment of common sense.

Posted by: Stephany at July 30, 2008 07:45 PM

Rosie,
So we both have learned a good lesson. I thought the same about FDA's job.

Knowing that DSM-5 research agenda cares a lot about "profilatic treatment" of mental diseases in childhood I'm getting more and more scared.
Sometimes I feel that something is about to happen to put it all on the front page of... "Time"; "Newsweek" - i like dreaming - but it only last one afternoon for I come to FS and receive a dose of reality.

Posted by: Ana at July 31, 2008 02:15 AM

I'm with Ana and Rosie. Philip, do you mind explaining for all of us how the FDA can "validate" an illness or a disorder? It just seems kind of odd that the FDA is an authority on allowing which disorders are real or not. I've never heard of this before.

Posted by: Marissa at July 31, 2008 07:38 AM

The British NICE (National Institute for Health and Clinical Excellence)do NOT accept the "paediatric bipolar" diagnoses as constructed in primarily the USA as valid diagnoses for clinical usage.

A survey (in press) of child & adolescent psychiatrists in Australia and New Zealand found very high rates of scepticism about paediatric bipolar.

92% of German child psychiatrists in southern Germany had never diagnosed bipolar disorder in pre-teens in their careers in a survey with a 60% response rate.

Posted by: Aussie Psychiatrist at July 31, 2008 09:18 AM

Yes, Thomas P.--it IS time these drugs have long term studies done, and my daughter is a living example of one who has been on antispychotics since age 11. She is currently 20 and pretty much disabled now. Risperdal nearly killed her at age 11, so the doctor replaced with Zyprexa, and when that went south they replaced it with Abilify, then Seroquel, then Clozaril.

I hope parents take warning from a mom here, that these drugs often promote agitation, psychosis, weight gain, diabetes, tremors, ocular dysfunction, polycystic ovary syndrome, and much more.

Far too much for a growing child's brain and developing body. Without out any study---well I'd like to know about other kids who went through this crap--I know one who posts here and I hope he/she posts again.

Posted by: Stephany at July 31, 2008 09:42 AM

In case anyone hasn't seen it, Frontline did an excellent episode on the rise in childhood bipolar diagnoses.

http://www.pbs.org/wgbh/pages/frontline/medicatedchild/

Posted by: J at July 31, 2008 03:11 PM

I would advise everyone to watch the Medicated Child PBS program for a review of the key players in that program. Biederman and crew and one Dr.Bacon that clearly are pro-meds for kids, it's sickening in my opinion.

Here's links from this site discussing that program worth reading:

January 09, 2008-"Frontline" On The Bipolar Child-Furious Seasons.

and

April 08, 2008-PBS Reruns "The Medicated Child" Tonight-Furious Seasons.

Posted by: Stephany at July 31, 2008 06:16 PM

This is just nuts....the FDA defining of validating an illness???? That is NOT there job.

Posted by: Naturalgal at August 1, 2008 06:46 AM

You know even if childhood Bipolar exists maybe drugs aren't the best way to treat 99.9% of cases. Maybe kids can grow out of it, I dunno. What I do know is that I would have qualified for a Bipolar Diagnosis as a kid due to the depressions and what could be called my anxious irritable hypomanic episodes... but really I think that had my family situation been addressed (ie my parents getting help with thier own abuse causing mental issues) I wouldn't have had nearly as many problems... and perhaps I wouldn't have been triggered into full blown Bipolar for all the years up to my sisters death which really kicked me over the edge.

All I know is that I am glad I wasn't given powerful drugs as a kid, I don't think I would be the same person I am now if I had been... but I do wish when I had gone for help as an adult that I had gotten the right dx immediately and been spared all the horrible things trying ssri's for my "depression" brought on me.

Posted by: katielou82 at August 1, 2008 06:46 AM
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