Apparent Discrepancy Between Published Study of Gabapentin Treatment and Internal Company Report

Evan Mayo-Wilson, MPA, DPhil

J Clin Psychiatry 2013;74(8):853-854

Article Abstract

Because this piece does not have an abstract, we have provided for your benefit the first 3 sentences of the full text.

To the Editor: I was concerned to read the recent report by Vedula et al that includes additional information obtained through litigation about an article published in the Journal (Vieta et al 2006).

Specifically, the company report indicates that 42 participants were randomized, but Vieta et al report that "twenty-five subjects aged from 18 to 75 years with a diagnosis of bipolar I or II disorder (according to DSM-IV criteria) treated with any standard mood stabilizer like lithium, valproate, carbamazepine, or any combination during the last year were recruited."

As there appears to be a discrepancy between the data submitted to the Journal and the company report, the latter should be made publicly available to allow readers to assess this study for themselves.

See reply by Vieta and related article by Vieta et al.

Apparent Discrepancy Between Published Study of Gabapentin Treatment and Internal Company Report

To the Editor: I was concerned to read the recent report by Vedula et al1 that includes additional information obtained through litigation about an article published in the Journal (Vieta et al 20062).

Specifically, the company report indicates that 42 participants were randomized, but Vieta et al report that "twenty-five subjects aged from 18 to 75 years with a diagnosis of bipolar I or II disorder (according to DSM-IV criteria) treated with any standard mood stabilizer like lithium, valproate, carbamazepine, or any combination during the last year were recruited."2(p474)

As there appears to be a discrepancy between the data submitted to the Journal and the company report, the latter should be made publicly available to allow readers to assess this study for themselves.

Thank you for your consideration.

References

1. Vedula SS, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin. PLoS Med. 2013;10(1):e1001378. PubMed doi:10.1371/journal.pmed.1001378

2. Vieta E, Manuel Goikolea J, Martínez-Arán A, et al. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. J Clin Psychiatry. 2006;67(3):473-477. PubMed doi:10.4088/JCP.v67n0320

Evan Mayo-Wilson, MPA, DPhil

[email protected]

Author affiliation: Centre for Outcomes Research and Effectiveness Research Clinical, Educational & Health Psychology University College London, London, United Kingdom.

Potential conflicts of interest: None reported.

Funding/support: None reported.

J Clin Psychiatry 2013;74(8):853-854 (doi:10.4088/JCP.13lr08420).

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