In addition, the letter (by Bernard Carroll) notes that data regarding weight gain are not reported in full, a troubling omission given that risperidone was apparently related to more weight gain than placebo. This borderline significant to statistically significant difference (depending on what analysis is used) was reported in a prior iteration of the study, but not in the final version as published in the journal.
Please see several prior posts regarding this study (1, 2, 3, 4, 5). It's a doozy. Mark Rapaport, the lead author of the study, in his reply to Carroll's letter, wrote the following:
The paper repeatedly states in Abstract, Methods and in Discussion that continuation of risperidone augmentation therapy was not more beneficial than placebo, and hence the working hypothesis was disproven...A couple things. First, does it really take all that much courage to publish a negative finding? Should a Nobel Prize or a Bronze Star be awarded? There should be little honor attached -- to paraphrase Chris Rock: Why should you get mega-credit for doing things you're supposed to do? Oooh, you published a negative finding. What do you want, a cookie? You're supposed to publish a negative finding you low expectation' havin' "independent scientist." The fact that somebody thinks props should be doled out because a negative finding was published shows how sad-sack the system has become.
I would like to thank the reviewers and the editors of Neuropsychopharmacology for having the courage to allow us to publish this negative finding.
To top it off, the study, as originally published, hardly painted its findings as negative, as can be seen in my aforementioned links to the study. Yes, there were a couple of small caveats about efficacy in the paper, but take a look at a snippet from the press release that accompanied the study:
In the first large-scale study of its kind, researchers at Cedars-Sinai found that people suffering from resistant major depressive disorder who don’t respond to standard antidepressants can benefit when the drug therapy is augmented by a broad spectrum psychotropic agent, even when treated for a brief period of time.Does that sound like a "negative finding" to you? If I am following this correctly, it went something like this: The study supports the efficacy of Risperdal for depression until a number of problems are found with the study, at which point the lead author indicates that they never said the findings were positive. I'm a little confused.
I hope to never again write about this study, as I feel like the proverbial dead horse-beating has begun.
Oh, and Happy New Year. I expect to be writing about similar stories throughout the year because while the names may change, the storyline remains the same.