September 11, 2009

60 Percent Of Antipsychotic Use In VA Off-Label

A new study out in Psychiatric Services asserts that a full 60 percent of antipsychotics prescribed in the VA system in 2007 were being prescribed off-label and, in my opinion, for conditions for which there is little scientific evidence supporting their use. These drugs are known to be dangerous, so you've got to wonder what the hell is going on at the VA and just how much illegal marketing pharma companies have engaged in to create this situation. The study most prominently identifies the off-label use of Seroquel and Risperdal.

Here's the stunner to me:

"The most common mental illness diagnoses among patients given prescriptions for antipsychotics off label were posttraumatic stress disorder (PTSD, 41.8%), minor depression (39.5%), major depression (23.4%), and anxiety disorder (20.0%)."

Seroquel and Risperdal simply aren't approved for those conditions. The study states that 279,778 people in 2007 got antipsychotic medication, 168,442 of them off-label. I know the VA gets deeply discounted prices and that the doses were on the small side, according to study authors, so let's assume that each of these 168,442 patients ran up $100 a month in antipsychotic expense to the VA system each month (that $100 might be low). That would work out to $202,106,400 in 2007 for off-label use of these drugs in the VA system. And people wonder why health care costs so much.

Over 168,000 people is a large group to give risky drugs to with little evidence of their effectiveness. That these are military veterans pisses me off immensely.

Even the study's authors conclude:

"Given that these drugs are expensive, have potentially severe side effects, and have limited evidence supporting their effectiveness for off-label usage, they should be used with greater caution."

Or maybe not used at all.

Someone has got to look into this situation because I smell a rat. The DOJ has pushed on the pharma companies over off-label marketing within the Medicare/Medicaid system, so it would stand to reason that they should have a look-see here as well. I know that Sen. Charles Grassley (R-Iowa) continues to look into off-label marketing, among other things. I hope he decides to press the appropriate parties for information on what's going on here. I think our veterans deserve that.

Posted by Philip Dawdy at September 11, 2009 12:03 AM
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Comments

I noticed that Seroquel, when I google it, now has a disclaimer that it can cause harm for people with dementia.

i just lost my father to alzheimer's disease, and know that he was just flooded with seroquel, almost to the very end. i believe one of the disclaimer's is that it can cause stroke, which is what happened to my father.

is there any legal actions that have prompted these disclaimers all of a sudden (i'd never seen them before)?

Posted by: Christine at September 11, 2009 04:51 AM

This does seem very strange. With Post-Traumatic Stress Disorder (PTSD), for example, I know that often in addition to a selective serotonin reuptake inhibitor (SSRI), the doctor may prescribe a beta-blocker to help with rage. However, this clinical social worker does not remember reading in my research for my recently released self-help book, "The Post-Traumatic Stress Disorder Relationship: How to Support Your Partner and Keep Your Relationship Healthy," that these drugs were ever recommended for PTSD.

Posted by: Diane England, Ph.D. at September 11, 2009 06:21 AM

"Seroquel and Risperdal simply aren't approved for those conditions."

That's why it's called off label prescribing; it's done will all medications, not just those approved for psychiatric disorders. And it's the doctor's call. You know, someone with the education, clinical experience, professional resources and integrity to be in a position to make that call.

Unlike someone who, say, just writes about these things. You know.

Posted by: The Visitor at September 11, 2009 06:49 AM

Maybe it's time for it not to be the doctor's call?

It seems to me that the privilege to use drugs for unapproved indications must be firmly rooted in an understanding that what you are doing is pure human experimentation. I think we are past the time to ask for IRB/IEC approval for such. If off label use constituted 6% of use I'd surmise that physicians are being responsible and are acutely aware of their ethical responsibility.

Alas, these sorts of number only serve to strengthen my view that medicine, especially psychiatry and to a lesser extent oncology, needs to be more tightly constrained. Better hurry up, the government will do this for us if we fail to act vigorously.

Posted by: Paul at September 11, 2009 11:45 AM

Only 60%??? Seriously, when I worked at the VA these drugs were given out like candy (and where I work now, they're given out like free candy!!!).

But there are two sides to the issue. Sometimes patients with these illnesses (like PTSD and depression) do have horrific and debilitating hallucinations or flashbacks that do resolve with antipsychotic treatment. So while Diane England, Ph.D. is correct that these drugs weren't "approved" for PTSD, she unfortunately neglects the pain and terror that psychotic symptoms might cause in some cases of PTSD.

On the other hand, there's one easy way to respond the off-label phenomenon, and that's to give out the diagnoses just as freely as we've been giving the meds. Unfortunately, I see my colleagues do this far too frequently--- i.e., labeling something schizophrenia or bipolar disorder (for which these medications are approved), when it clearly is not--- which "permits" them to give, say, Seroquel for sleep or Risperdal for agitated dementia.

Finally, I agree, in principle, with The Visitor. However, once you start working with psychiatrists, you realize that an MD degree doesn't necessarily equate with "education, clinical experience, professional resources and integrity." It more often means "let's just prescribe and see what works."

Posted by: SteveBMD at September 11, 2009 12:59 PM

Hey doctor's integrity and choices made to use off-label psych meds are backed with sufficient data to question the usefulness of the drug--ghostwriting, buried data (seroquel/zyprexa)COI researchers pocketing pharma company money....for a doctor to "make a call" on a psych drug use, clearly means they know nothing more than those, who say "just write about it". You know.

The drugs "proof" of efficacy FOR label rx is questionable, let alone off-label, it's a damn crap shoot and we all know it.

It's why doctors call it "meds adjusting" or tweaking the meds, or "trying a new cocktail" or "micro-managing meds".

It's your call doc, and at the end of the day no one has any answers, no one does.

Posted by: Stephany at September 11, 2009 01:10 PM

Some people need treatment. They work with doctors to find something that works -- not always something that the literature says will work.

The main concern when prescribing psych meds off-label or on label is that the patient is safe. Doctors are in the best position to make that call. Almost everything else is determined mostly by the patients subjective experience.

Posted by: Tyler at September 11, 2009 04:50 PM

Since antipsychotics are given out for everything under the sun, why do we need psychiatrists? Let's just fill up the vending machines with seroquel and be done with it.

Posted by: Lisa at September 11, 2009 07:15 PM

The Visitor said:

"That's why it's called off label prescribing; it's done will all medications, not just those approved for psychiatric disorders. And it's the doctor's call."

Interesting? The Visitor must live on some other planet

This apologist seems to believe Doctors are some sort of infallible Gods that are not influenced by greed (pharma pay offs), marketing (Here's a nice weekend golf trip on big Pharma's tab, "now take this pill and push it") misinformation and propaganda (skewed studies and ghost written lies being passed off as science), and a whole host of other unsavory and unethical behaviors.

Any doctor out there willing to stand up and admit publicly they just "SCREWED UP"; while letting greed and misinformation cloud their judgment. It's always lots of tired old excuses that among to nothing more than recycled BULLSHIT.

I personally trust the medical profession at this juncture about as much as I trust government and Obama's health care lies; with great suspicion and guarded skepticism.

Maybe when I see convicted felons like huge PhARMA Corporations doing some serious prison time; and our government stops doing business with these criminal entities; my mind possibly could be swayed once more.

Posted by: Ms. Piggy at September 12, 2009 08:37 AM

You know Tyler, the patient's "subjective" experience is the ONE THAT COUNTS. Honestly, what doctor can claim to know what the hell these drugs make your mind and body feel like?

Hell, if the doctors are on meds for a psych dx think they will disclose that? yeah right!

There's not one smug comment here that will ever top the patient experience and promote the "but I'm the doctor" crap. Not here. the doctors that do post comments here so far don't harp that arrogance, and some who have stopped commenting. Just my opinion, after a decade of seeing someone trial dozens of these meds I unfortunatly know more than some ever want to imagine.

They don't work!

Posted by: Stephany at September 12, 2009 04:44 PM

Stephany, in the interest of full disclosure, I'm a psychiatrist and I have been on psych meds in the past (for a disorder which appears to be safely behind me today). I do share this information with patients when relevant-- ie, when treating a patient with similar problems-- because I find it to be much more valuable in my treatment approach than anything I've read in a textbook.

The reason I try to prescribe meds only sparingly is not because of potential adverse effects (although that's clearly significant), but because they're simply not effective for the majority of what patients come to see me for. Meds did absolutely nothing for me; not to go into too much detail, but I recovered thanks to psychotherapy, hard work, support groups, and a reconsideration of my life goals.

I don't know what frustrates me more-- the fact that drug companies are trying to push expensive, potentially unsafe, and essentially unproven (and marginally effective) meds on as many people as possible, or that the rest of us have largely accepted the medication model of mental health treatment. Hey pharma is a business and, right or wrong, they're just trying to increase market share. Unfortunately, doctors-- and, yes, lots of patients-- have fallen blindly for their myth that drugs cure everything: "stress," everyday sadness, poor self-esteem, body image issues, fears & worries, poor sleep, substance abuse, anxiety & nervousness, and so forth. When a psychiatrist prescribes a med and does nothing more with the patient, he/she is fostering that myth and disempowering the patient from making much healthier decisions for him- or herself.

Posted by: SteveBMD at September 13, 2009 06:15 PM

Just so everyone here will know I'm not a *total* harpy when it comes to psychiatrists:

SteveBMD,
Bless you.

Posted by: Sherry at September 14, 2009 05:34 AM

Off-label itlsef is not bad. Antipsychotics off-label for ptsd is just not supported at the levels portrayed here. Sadly, there is no med for ptsd, although apparently the drug reps have convinced the VA that antisychotics are 'it.'

Beta blockers are not such a bad deal, as the health effects are much less severe, and more widely known. For some, they work.

the VA probably still cannot get Prazosin prescribed at the levels it should to help ptsd vets with sleep. Raskind keeps publishing this info, and trying to spread it within VA, but it is not patented, it is dirt cheap, so no rep is pushing it. A fair amount of the irritation and depression seen in ptsd is related to poor sleep. Helping the ptsd vets get decent sleep does not cure ptsd, but makes it a lot better than nothing - and it may do a lot more than ssri or antipsychotics.

Orange Mate mist spray, available in many places, helps a lot of vets with ptsd to stave off the spaced-out episodes, if they can recognize the space-outs and act in time. smelling a natural air freshener is a lot better than taking a diabetes-inducing pill.

Finally, the VA just flat-out needs to be figuring out ways to provide psychotherapy. One VA coped with the huge numbers and wait-times by developing a patient-and-spouse psychoeducational treatment - with minimal hassle - the sessions are established, and anyone who is a potential ptsd patient is welcome to show up ya just gotta sign in so your attendance can be documented. this is four weeks or so, and simply repeats. Patients and spouses love it. It helps to a modest degree.

Each ptsd pt has their own handful of things to address. Medical personnel get traumatized partly by failing to help 100%; there is no such thing a as a good day when you are trying to heal those wounded in battle. A good day is 100% success. Failing with even one soldier is haunting. Alternately, some get haunted by extreme vigilence needed for booby-traps. Some Korea war vets get bothered by cold weather, while some Vietnam war vets get bothered by fog. Each needs a different set of things to help. These two oversimplified ideas are just to show that it is overly simplistic to think that pills will resolve ptsd.

pills just cannot do this job. you need a skilled, educated clinician who cares and has time.

Posted by: medsvstherapy at September 14, 2009 08:14 AM

SteveBMD,

I appreciate your honesty. If I had found a good therapist to begin with I would have saved myself a world of hurt.

Posted by: Lisa at September 14, 2009 09:54 PM

I am living a life of HELL. My STUPID psychiatrist has (for the past 15 yrs) prescribed Klonopin for my anxiety. It took me long enough to realize that this HORRIBLE drug has ruined my life.

I HATE PSYCH MEDS. I have been on sooooooooo many meds that I can't take it anymore.

Posted by: Janet at September 17, 2009 01:28 PM
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