September 15, 2006

What is Off Label Usage?

Some guys in Georgia do a massive study and discover that doctors use medications off label.  They also determine that that's bad.

The real question is not why we use them off label, but why we persist in thinking that means anything.   

First, the core problem with the paper, and the entire thesis of the validity of indications, is that the definition is recursive.  A drug has an indication because it was found effective for a cluster of symptoms that we have defined as a disorder.  This does not necessarily make the disorder valid, and it does not preclude the drug’s efficacy elsewhere. 

In other words, it tells you what it is good for, but not what it isn’t good for.

So what is the value of an indication?

Can someone clarify the basis for the arbitrary distinction between “dementia related psychosis” and any other kind of psychosis?  Is there new PET data that I missed that distinguishes the two?

Similarly, to say a drug “is” an antidepressant doesn’t mean it isn’t actually an antipsychotic.  For example, what is it, exactly, about Prozac that makes it not an antipsychotic?  The only legitimate answer is that when tested, Prozac didn’t work in psychosis—not that an antidepressant can’t be an antipsychotic.  It is an artificial hierarchy that puts “antidepressant” below/weaker than “antipsychotic.”  Try the reverse: can an antipsychotic be an antidepressant?  Why is that easier to believe?


Thus, categorizing a medication based on an arbitrary selection of invented indications to pursue—and then restricting its use elsewhere—may not only be bad practice, it may be outright immoral.


I do not make the accusation lightly.  Consider the problem of antipsychotics for children.  It is an indisputable fact that some kids respond to antipsychotics.  They are not indicated in kids.  But don’t think for a minute there will be any new antipsychotics indicated for kids.  Who, exactly, will pursue the two  double blind, placebo controlled studies necessary to get the indication? No drug company would ever assume the massive risk of such a study-- let alone two-- in kids. 

And which parents will permit their child in an experimental protocol of a “toxic” antipsychotic?  Rich parents?  No way. The burden of testing will be undoubtedly born by the poor—and thus will come the social and racial implications of testing on poor minorities. Pharma is loathed by the public and doctors alike, and the market  for the drugs in kids is (let’s face it) is effectively already penetrated.   There will not be any new pediatric indications for psych meds.  Not in this climate.  Think this hurts Pharma?  It's the kids that suffer.

Lastly, the likely most common laments to this paper will be that it will be used by insurance companies to further restrict the practice of psychiatrists.  Too bad.  If psychiatrists cannot be bothered to learn how medications work and their appropriate usage, then unfortunately the State must intervene.  It is, after all, their money, and it is not infinite.  But restricting formularies based on "approved indications" (read: nothing) is not the solution.  If the problem is economic (and it is) then you need an economic solution.  And you're not going to like it.



Off-Label Use of Antidepressant, Anticonvulsant, and Antipsychotic Medications Among Georgia Medicaid Enrollees in 2001.Hua Chen, Jaxk H. Reeves, Jack E. Fincham, William K. Kennedy, Jeffrey H. Dorfman, and Bradley C. Martin 67:6 2006.