Monday, September 08, 2008

Atypical Antipsychotics for All, Oregon Chapter

Oh boy. Here we go again. A study published online ahead of print at the Journal of Clinical Psychiatry notes that among Oregon Medicaid patients who received a prescription for an atypical antipsychotic:
  • 52% had a depression diagnosis
  • 34% had an anxiety diagnosis
  • 15% had a PTSD diagnosis

But only 15% had a schizophrenia diagnosis and 27% had a bipolar diagnosis. So... the majority of atypical scripts were written off-label. Seroquel was the most frequently prescribed atypical, followed by Zyprexa, then Risperdal.

Doses less than what are typically given to treat schizhophrenia or bipolar disorder (subtherapeutic dosing) were quite common. As in 86% of Seroquel scripts were subtherapeutic, 59% of of Risperdal scripts, and 48% of Zyprexa prescriptions. Wait, am I calling for higher doses of these drugs? That doesn't sound like me at all, right? Don't worry, I haven't lost my mind (I think).

Here's the deal. The authors suspect that a lot of these low-dose prescriptions are being written to manage agitation and as sleep aids. The authors note that there are likely less expensive/more effective medications for such conditions. Not to sound too cavalier, but one could also recommend behavioral treatment to help with sleep as well. Nah, that's crazy talk -- not enough money to be made in that.

Primary care docs were more likely than psychiatrists to dish out low-dose antipsychotics. I guess that the Viva Zyprexa marketing blitz was a success after all. Thanks to Daniel Hartung and collagues for their study, which provides another insight into the wonderful world of atypical antipsychotics as a treatment for everything imaginable. Sorry to beat a dead horse with my zillionth post about the topic of atypicals, but isn't this getting just a teeny bit out of control?

Daniel M Hartung, Jennifer P Wisdom, David A Pollack, Ann M Hamer, Dean G Haxby, Luke Middleton, Bentson H McFarland (2008). Patterns of atypical antipsychotic subtherapeutic dosing among Oregon Medicaid patients Journal of Clinical Psychiatry DOI: ej07m03658


Anonymous said...

Great scoop. I can vouch for the behavioral therapy. I'm a member of the American Academy of Sleep Medicine, and behavioral therapy and CBT-I (cognitive behavioral therapy for insomnia) has been shown to be equally effective to sleep aids in the short-term and superior in the long term (with large effect sizes). The other part I don't get is, there are specific drugs indicated for insomnia and they are never prescribed. Trazedone is the number sleep aid in this country (2004 data), yet it merges with placebo by week two. OTC dihpenhydramine would work just as well.

Second, I need some assistance. I'm preparing a post on abilify and I am looking for the research that got BMS the FDA approval for pediatric bipolar and adolescent schizo. However, the work appears unpublished. In the press releases and adverts, the references list "Data on file at Otsuka America Pharmaceutical, Inc." I can only find abstracts that were presented, but the listed authors are employees of Otsuka. Do you know anything?

CL Psych said...

Thanks. Try going here to find what you can. I doubt there is much on the FDA's site, however.

And you're indeed right on about behavioral therapy for sleep. I've not seen the data on trazodone, but I would not be surprised if you're completely correct.

From a press release for Abilify discussing these hard to track down data: "During the study, the most commonly observed adverse reactions (greater than or equal to 5% in combined ABILIFY groups and at least twice the rate of placebo) associated with ABILIFY were: somnolence (ABILIFY: 23%; placebo: 3%), extrapyramidal disorder (ABILIFY: 20%; placebo: 3%), fatigue (ABILIFY: 11%; placebo: 4%), nausea (ABILIFY: 11%; placebo: 4%), akathisia (ABILIFY: 10%; placebo: 2%), blurred vision (ABILIFY: 8%; placebo: 0%), salivary hypersecretion (ABILIFY: 6%; placebo: 0%) and dizziness (ABILIFY: 5%; placebo: 1%). Four common adverse reactions had a possible dose-response relationship at Week 4: extrapyramidal disorder (ABILIFY 10 mg: 12.2%; ABILIFY 30 mg: 27.3%; placebo: 3.1%), somnolence (ABILIFY 10 mg: 19.4%; ABILIFY 30 mg: 26.3%; placebo: 3.1%), akathisia (ABILIFY 10 mg: 8.2%; ABILIFY 30 mg: 11.1%; placebo: 2.1%) and salivary hypersecretion (ABILIFY 10 mg: 3.1%; ABILIFY 30 mg: 8.1%; placebo: 0%). Children and adolescents might be more sensitive than adults in developing antipsychotic-related adverse events.(1)"

Gee, if I were a 10 year old with "bipolar" and I were looking for some akathisia, drooling, EPS, and weight gain, I know where I'd turn...

Mark p.s.2 said...

As a schizophrenic I would like to point out many schizophrenics do not want the prescription of an antipsychotic. To get housing and food etc we usually have to take the magical medication that make us "good" instead of "bad". Schizophrenia has nothing to do with free will, learned behaviour or choice of course.

We don't deserve "akathisia, drooling, EPS, and weight gain" or tardive dyskinesia either.

Anonymous said...

There is something inherently wrong in seeing antipsychotics being pushed to treat illnesses outside the diagnostic realm of thought disorders. I'm not even a fan they have a place in Bipolar disorder beyond the acuity of mania; they don't have a place in treating depression, in my opinion.

If there is a force or outside process that does watch out for those of us invested in the world, I hope it reveals the agenda the pharmaceutical industry has tried to force on those with mental illness. I am not trying to be bizarre or outlandish, just trying to make sense of what is senseless to me with this horrendous push for global medicating of societies.

Not that medications have no place in the process, just not the ONLY place, as many relate in their tales. Anyone else have a perspective from experience?

Anonymous said...

CP: "The authors note that there are likely less expensive/more effective medications for such conditions."

Yeah, especially for Seroquel, which has strong preferential binding to H1 receptors - almost to the exclusion of dopamine and serotonin receptors at low doses.

So a good substitute for low dose Seroquel would be a cheap over-the-counter antihistamine, like Promethazine.

And Risperdal and Zyprexa will pretty much only effect 5-HT at low doses.

insider said...

Here's the AZ Seroquel sidewiki (written by yours truly) in full:

Welcome to the blogosphere!
Question 1. How much did Dave Brennan know about "The Seroquel Issue" at the time?

The pharmaceutical company AstraZeneca said Thursday (29/Oct/09) that it had reached a $520 million agreement to settle two federal investigations and two whistle-blower lawsuits over the sale and marketing of its blockbuster psychiatric drug Seroquel.

One of the investigations related to “selected physicians who participated in clinical trials involving Seroquel,” AstraZeneca disclosed in a government filing. The other case related to off-label promotion of the drug.

H. Waxman's letter:

The Zoladex issue:

Question 2

What do you think Corporate Integrity Agreements are?

This might help.

Question 3

Is Dr Michael Reinstein one of the Seroquel investigators under investigation by the DoJ?

Today's question (4):

Was Geoff Birkett the "man behind the curtain" in the Seroquel Scandal?

Someone has to take the fall Dave!,0,6067737.story

Last question, for now:

If you or AZ or anyone have any issues of fact about any of this then please say and it will be changed/removed. If not, the so be it!