February 29, 2008

The Bipolar Child: Abilify Approved For 10 Year Olds

The FDA today approved the atypical antipsychotics Abilify for use in treating bipolar disorder in kids as young as 10 years old. Of course, there's much controversy in the land about what age a doctor can properly diagnose bipolar disorder at and 10 years old would sure seem to be pushing it by the FDA since most clinical literature I am aware of talks about 12 and above.

But whatever. We live in times when the needs of Big Pharma and not the needs of children are the prime concern of our society.

One psych bigshot opined:

"Abilify offers a potential advantage over other atypical antipsychotics because 'it doesn't cause to the same degree weight gain and metabolic' disorders, said Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York, in a telephone interview yesterday.

"'The major problem with second-generation antipsychotic drugs is weight gain and diabetes,' Lieberman said. 'The younger you are, the more severe and common these side effects.'"

Gee, and here I thought schizophrenia in adults was Lieberman's thing.

Bristol Myers-Squibb said:

"'The approval is one of a series we've had for Abilify in a short amount of time,' Sonia Choi, a Bristol-Myers spokeswoman, said in a phone interview. 'This is evidence of our commitment to developing medicines to their full potential.'"

Full potential for whom? Here's a separate company statement.

Between the Seroquel XR application for depression that just hit and this approval for Abilify, we are seeing one of the biggest land grabs ever by Big Pharma for the American mind.

Meanwhile, Lilly is licking its chops:

"Lilly's request to sell Zyprexa to treat schizophrenia and bipolar disorder in teenagers was delayed by the FDA in April. Lilly received what the FDA calls an approvable letter, indicating the agency needs more time to analyze data and to determine the drug's prescribing information.

"'We don't have a time frame at this point,' Lilly spokeswoman Marni Lemons said in a phone interview. 'We have no intention for promoting the drug for use in adolescents. We want to add information to the label.'"

Can't wait to see that information.

Posted by Philip Dawdy at February 29, 2008 09:42 AM
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Comments

Oh well, it just goes along with Risperdal and the only difference between now and 1999 is that these drugs are getting FDA approval for use in kids this young, whereas with my daughter when she was 11, they were not approved for kids under age 18.

So, I guess the Pharma companies feel pretty damn legitimate now, and for that matter so do a lot of psychiatrists and Joe Biederman and Crew and sleep tonight.

What a relief! antipsychotics for kids! what a great, great day. Why did Judith go on book leave now? She sure would run this one up the flagpole.

*note, these are my opinions based on experience and somehow feel entitled to be sarcastic. If these drugs work for your or your child I am not judging use of them.

Though I do recommend readers watch PBS Frontline: The Medicated Child, and keep this drug approval in mind when watching.

Posted by: Stephany at February 29, 2008 11:36 AM

Personal anecdotal story regarding both Risperdal and Abilify:

Risperdal: was given to my daughter at age 11 when misdiagnosed with Childhood Bipolar Disorder. It caused severe reaction, where her eyes were STUCK looking straight up. Doctors pulled the drug out of her cocktail and replaced it with Zyprexa, which did the same thing, not to mention 100 lbs weight gain.

Abilify: was given to my daughter at age 17 and it caused severe agitation, aggression and insomnia.

Both of those trials were inpatient in psych wards with 24 hour observation by professionals.

Keep that in mind if a child is at home experiencing any event that was not there to begin with, and agitation is one where doctors tend to increase the dose, per being used for agitation. Then pay close attention and consider the drug as a culprit.

All of my words are based on personal experience and am not making a statement for challenge or defense, I am just adding anecdotal stories where they may be helpful.

Posted by: Stephany at February 29, 2008 11:43 AM

I remember Marni Lemons lying through her teeth back in March 2003, denying that Zyprexa had anything to do with diabetes. I guess when you are given a lemon such as Zyprexa, you make lemonade. Marni, how can you lie day after day?. Is it because you are "following orders?" "Anything for a good paycheck?" It will be another black day if/when the FDA approves Zyprexa for children.

Posted by: Sorrowful at February 29, 2008 11:44 AM

This article says the approval was based on a 4 week study! A four week study! It seems odd to me that a treatment for a disease there's no consensus even exists that is impossible to diagnose, a treatment that is so painful and unpleasant many adults choose to die of starvation and exposure on the streets while suffering from terrifying auditory and visual hallucinations rather than take, a treatment that adults legally forced to take choose instead imprisonment in filthy, abusive psychiatric hospitals, was approved for innocent children in 4 weeks. It's scary to think how much more horrible injectible zyprexa must be to not pass the muster (I know it's for adults still). Good to have a place to vent.

Posted by: Sally at February 29, 2008 12:38 PM

Yeah Sally, and you know what else? most ALL trials don't go past 2-3 months right about when most people have side effects show up. The 8 week mark is famous for drugs such as Prozac to "suddenly poop out" or create mania in some people. Not to mention, long, long term effects, as in people don't gain 100 pounds in 4 weeks.

Honest to God, this stuff drives me nuts.

Posted by: Stephany at February 29, 2008 04:53 PM

I was reading Informed Consent Bill On Psychotropics article and noticed a name that commenter"AA" has mentioned in quite a few comments,with regard to Laurie Yorke. This is an interesting piece of Legislation these women are working on, and I'm wondering if it's the same Laurie Yorke?

Posted by: Stephany at February 29, 2008 07:13 PM

Stephany, 2 - 3 months, that's absurd. Here's the link to the article that said this study was 4 weeks:

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/02/29/hscout613151.html

I forgot to paste it in before. 4 weeks really seems quick. How can you possibly determine the long term effects of a drug if it's only tested for 4 weeks? And of course there's the obvious question, what kids are these drugs tested on?

Posted by: Sally at February 29, 2008 09:06 PM

Hi Stephanie,

It is the same Laurie Yorke. She is a remarkable women

AA

Posted by: AA at March 1, 2008 10:38 AM

ah, but as long as the child is seen but not heard, who really cares if she is diabetic, self-mutilating, or still suffering from side effects 15 years later. what's important is that little sally sits still.

Posted by: mrs lot at March 1, 2008 11:18 AM

Thanks AA, wow inspirational women for sure.

--Sally, Joe Biederman tested little kids on Risperdal, I've got the abstract somewhere on my blog, I'll dig it up soon. There are "studies" parents can enroll in and there are placebos, the drug and sometimes therapy involved, and as we know no one knows what they get, the drug or placebo.

Not sure any drug is fully approved for serious studies in kids, I do know that Martha Hellander from CABF bpkids dot org went to DC to testify to FDA to approve Lithium testing in children years ago.

Hell no drug trial matters at a point as much as following the kids lives for 20 years---and see how the kids ended up. Like that PBS frontline program showed some kids pretty harmed in my opinion, [like my daughter].

Posted by: Stephany at March 1, 2008 12:29 PM

Dear Mrs. Lot,

I'll just take a deep breath and thank the Goddess they didn't have this stuff when I was a kid.

Sally

Posted by: Sally at March 1, 2008 01:45 PM

My high school age son began suffering from bipolar about a year ago has been taking a pediatric dose of Abilify (2mg tablets 3x a day)for about 4 months now and the results have been amazing. No side effects. His grades have dramatically improved; his teachers report positive changes in attitude, he still gets angry and still have episodes of mind racing/confusion but has better personal control over his reactions and he feels like the drug is giving him his life back. In combination with how to cope with bipolar therapy, this drug is great. I feel fortunate to have insurance. The biggest drawback to the drug is its expense. For the uninsured, the retail price at Walgreens is $1747.89 a month. I checked on line and found it even more expensive elsewhere. Not sure why this particular drug/dose is so expensive.

Posted by: Melinda at March 17, 2008 11:39 AM
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