Thursday, September 07, 2006

Neurontin For All of Your (Non-FDA Indicated) Ills

Absolutely spot on article from Steinman, Bero, Chren, and Landefeld. Of course, the Lisa Bero train has been publishing a gold mine of fascinating research on the tobacco and drug industries for years, so this is what I've come to expect from them.

As some of my practicing mental health professional colleagues are aware, Neurontin (gabapentin) was never approved for use with psychiatric populations. That, of course, did not stop reps from aggressively marketing the drug for psych populations. I'm only including part of the story here -- there's much more in the article.

Steinman, MA, Bero, LA, Chren, M, & Landefeld CS (2006) Narrative Review: The promotion of gabapentin: An analysis of internal industry documents. Annals of Internal Medicine, 145, 284-293.

Here's an interesting quote from the article regarding the intersection of marketing and research in the case of Neurontin...

"However, in other cases Parke-Davis employed a “publication strategy, the goal of which was to use research not as a means to gain FDA approval for new indications but “to disseminate the information as widely as possible through the world's medical literature (77), generating excitement in the market and stimulating off-label prescribing despite the lack of FDA approval (78, 79). This strategy focused primarily on expanding gabapentin use in neuropathic
pain and bipolar disorders, for which detailed decision analyses projected the greatest revenue potential (80-83). The success of this strategy depended in part on publications being favorable to gabapentin. Some employees of Parke-Davis felt an obligation to publish studies with unfavorable results (80, 84), and in a number of instances such results were published (85-87). However, management expressed concern that negative results could harm promotional efforts (88), and several documents indicate the intention to publish and publicize results only if they
reflected favorably on gabapentin (78, 79). As stated in a marketing assessment, "“The results of the recommended exploratory trials in neuropathic pain, if positive, will be publicized in medical congresses and published" (italics added) (78). Similarly, in discussing 2 nearly identical trials
that yielded conflicting results on gabapentin as seizure monotherapy, the "“core marketing team”" concluded that "“the results of [the negative trial] will not be published" (89). (The positive trial was published [90], but we could not locate the negative trial on a PubMed search.) (p. 288)."


Anonymous said...

This is not at all surprising. I skim through similar blogs (such as PharmaGossip) daily, finding all sorts of similar stories. It seems like this is unfortunately just a drop in the bucket.

Looks like your blog has the potential to be rather interesting. Good luck!

CL Psych said...

Thanks! Just trying to get off the ground here. I'll post more about Neurontin and other issues soon. Check back often.