November 3, 2006

The Charade is Revealed-- We Are Doomed

Here's a question: can an antipsychotic be an antidepressant?  Why, or why not?

The correct answer is that the question is invalid, because there is no such thing as an "antipsychotic" or an "antidepressant."  We (should) define them based on what they do, not what they are.  Therefore, Wellbutrin and Effexor are both antidepressants if and only if they both treat depression-- not because of some element of their pharmacologies, which are anyway different.  Strattera, on the other hand-- which has a pharmacology (in some ways) similar to Effexor-- is not an antidepressant, only because it doesn't treat depression.

Following, just because something is called an antidepressant, or antihypertensive, it doesn't necessarily take on all the other properties or side effects of the others in its "class."   Not all "antidepressants" have withdrawal syndromes (only SSRIs do).  Not all antihypertensives cause urination (only diuretics do.)  You wouldn't dare put a "class labeling" on "antihypertensives" of "diuresis."

So you see where I'm going with this-- except you don't. 

I've previously yelled about the inanity of "antipsychotic induced diabetes" or "antidepressant induced mania" when they ignore pharmacologies, doses, and, of course, actual data.

But today I saw something that I now understand to be one of the signs of the Apocalypse.  It is the new package insert of Seroquel, which just got a new indication for the treatment of bipolar depression.  The new PI reads:


Suicidality in children and adolescents - antidepressants increased the risk of suicidal thinking and behavior (4% vs 2% for placebo) in short-term studies of 9 antidepressant drugs in children and adolescents with major depressive disorder and other psychiatric disorders.  Patients started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior.  Families and caregivers should be advised of the need for close observation and communication with the prescriber.  SEROQUEL® is not approved for use in pediatric patients. (see Boxed Warning)


Stating the obvious: in none of these 9 studies was any patient actually ever on Seroquel; Seroquel itself is not associated with a risk of suicide; it's not even been tested for major depressive disorder; and, well, this isn't very rigorous science, is it?

Just because a is now called an antidepressant, it carries the same risk as the SSRIs? (Whether even SSRIs have this risk is besides the point.)  Isn't that, well, racist?

This is not really about preventing suicide.  If we were worried about suicide, really, then why 24 hours before the FDA posted this warning, no one cared about Seroquel's doubling of the suicide rate?  Oh, because it doesn't actually double the suicide rate?  Die.

So the game is clearly not about science, it's about politics, it's about liability, it's about money. 

If this was honestly about about protecting children from suicide, we'd shrug our shoulders and say, "well, they're just very, very cautious, so we'll be careful and keep going."  But that's not what this is.  What this is factually inaccurate, misleading, and therefore more dangerous, more harmful.  In a simple example, this warning protects no one for a risk of suicide-- no potentially suicidal patient is going to look at this and say, "well, crap, I'm not taking this."  But it may prevent someone from taking it when they could actually benefit.  See?

This is Structuralism gone very badly awry, Saussure  just bought a pick axe and he's come looking for us all.

1 Comment