Sunday, June 27, 2004

More Information on Cymbalta (duloxetine)

The new antidepressant, Cymbalta (generic name: duloxetine) is expected to be released in early July.  Recently, I received some marketing materials from Eli Lilly, the manufacturer.  The point to a website, www.depressionadvances.com.  If you go to the site, you will not see any information about Cymbalta.  That is because the FDA does not allow active promotion of the specific product until the final release date.  Instead, what they do (all pharmaceutical companies do this) is they put out material that paves the way for their product-specific promotion.  Looking at the advance material gives you some idea of how they plan to market the product. 

Another site, www.dualityofdepression.com, allows physicians to register for a dinner program to take place on the launch date: 7/8/2004.  The program will consist of a live televised presentation, followed by a question-and-answer session.  I probably won't go, since it is on a Thursday night, and I usually take my wife to dinner on Thursday night.  Since she is a social worker, it would be within the ethical guidelines for her to attend, but it is not exactly the kind of thing that makes a woman feel special, you know.  I'll see what she thinks about the idea.  Maybe.  Anyway, neither of the Lilly websites really has much information that you can't get somewhere else. 

What is more interesting is the exchange of articles posted on The Carlat Report.  The Carlat Report is a newsletter for psychiatrists, that seems to be a bit of a gadfly.  That is, they like to dismiss the hype and focus on the facts.  Most of their stuff is available only by paid subscription, but they posted the Cymbalta material openly.  In January 2004, they had an article called Cymbalta: Dual the Reuptake, Triple the Hype.  The conclusion:

The statistics are sound, but the presentation is devious. A more ethical approach would be to present only the LOCF results in the abstracts, and to present the unorthodox MMRM results in a separate, secondary section within the body of the paper. But then Cymbalta would come across as just another modestly effective antidepressant-exactly what it is.

Thus, they are not dismissive of the medication, by any means, but they are critical of the marketing.  Eli Lilly, of course, came up with a response.  The response is incredibly dense, with a discussion of statistical methodology.  Carlat wrote a response to the response, which is here.  The counter-response is somewhat dry.  They point out that Lilly's response makes reference to unpublished data.  Carlat points out, rightly, that they will reserve judgment on that.  Once the unpublished data are published and subject to peer review, they will reassess the product. 

If you don't want to view the three PDF's and wade through the numbers, I'll save you some trouble and post the final two paragraphs:

Eli Lilly refutes our implication that duloxetine has no advantages over other antidepressants. Again, that implication was based purely on our reading of the available published data. When we looked at LOCF response and remission rates, we found numbers that were comparable to numbers reported for existing FDA-approved antidepressants (response rates 45-50%, remission rates 31-43%). In its response, Lilly refers to a wealth of unpublished data that sounds impressive; we look forward to seeing it in print.

In conclusion, TCR believes that duloxetine is an effective antidepressant. However, based on the available published data, it does not appear to be as “special” as Eli Lilly would like us to believe. If the accumulating data proves us wrong, be assured that these studies will be featured very prominently in future issues of The Carlat Report.

So far, the TCR conclusion is pretty much what I expected.  Still, even if it turns out that Cymbalta is just another modestly effective antidepressant, it still is a good thing to have available.  every time a new drug becomes available, it turns out to be just the right thing for some subset of patients.  We always need to have more options available.