The FDA (Federal Douche Association), approved the barely prescribed Symbyax (1) for treatment resistant depression (TRD). You'll notice that the press release says that Symbyax is the "First Medication" approved for TRD.
This is pure marketing. Current standard of care for depression is extremely lame. Instead of acknowledging that, people spin it, creating this beast we now call treatment resistant depression.
Other's have already written about this drug (2, 3). So, I'm not going to rehash what's already been said. Many of the studies submitted to the FDA have not been published (shocker!). Here is a link to two studies that were pooled together as "supporting data" for the FDA (4). There is nothing new here to really criticise. These two studies have the same flaws as all other antidepressant studies.
Here is what I take away from the FDA approval: Zyprexa can now be advertised and prescribed for major depression without that being considered off-label. Lilly has been in a lot of trouble for pushing Zyprexa for off-label uses (5).
Symbyax has been around for a few years. Originally indicated for bipolar depression, it has not been prescribed a lot. One reason is that it is cheaper to prescribe the two drugs separately. It also gives the prescribing doctor more freedom to tweak the doses of individual drugs as opposed to the approved combination doses. Moreover, the data that is provided show that olanzapine alone was almost equal to fluoxetine alone. I'm pretty sure there are many docs out there who will use that as an excuse to prescribe Zyprexa alone for depression (they already do by the way).
Here are some questions I never hear asked: Assuming the drug actually does something, what does that say about the biological mechanism of depression? Zyprexa is a dirty drug, it kind of hits up all the major neurotransmitter systems. Does that mean no more monoamine hypothesis of depression? Has the research over the last 30 years been crap? Are bipolar depression and unipolar depression no longer distinct biological entities since they respond to the same treatment? Is the bipolar/unipolar distinction another marketing gimmick? I don't know what to believe anymore, I don't know what's black and what's white, what's right and what's wrong...I'm lost, I'm lost...