Evidence, regulation and “rational” prescribing: the case of gabapentin for neuropathic pain.

Abstract

Rationale, aims and objectives: In 2004, the pharmaceutical company Warner-Lambert paid US$430million to resolve criminal and civil legal liability for aggressive off-label marketing of gabapentin. Perhaps surprisingly, however, regulatory and legal concerns regarding the marketing of gabapentin has not significantly impacted upon the attitude of physicians towards using gabapentin for neuropathic pain. In this paper we attempt to understand the reasons for this discrepancy between clinical practice and regulatory/legal concerns through an analysis of published discussions about gabapentin prescribing. Methods: We performed a qualitative empirical analysis of the published clinical debate surrounding the use of gabapentin for the management of neuropathic pain. Results: The ongoing use of gabapentin for neuropathic pain use was primarily driven by the perception that it was a safe, non-addictive drug with few drug interactions, by possible similarities between the physiology of chronic pain and other neurological conditions, by the well-established clinical precedent of using antiepileptic drugs in pain management, and by the lack of alternative options available in the market. Emerging evidence of lack of effectiveness and controversies about the integrity of the scientific record appeared to be of relatively little importance to practicing clinicians. Conclusions: Those who want to promote “rational” prescribing need to recognise that prescribing is driven by many factors other than epidemiological data and regulatory indications and that even intensely negative publicity about medicines may not penetrate clinical reasoning. This suggests that a range of measures may be needed to ‘incentivise’ rational prescribing and to promote research integrity. Regulators must be more sensitive to the contextual issues that are relevant to clinical practice when evaluating drugs for approval and developing guidelines. KEYWORDS: Chronic Pain; Neuralgia; Pain Management; Off-Label Use; Drug Industry; Physician’s Practice Patterns.