Characteristics and Impact of Drug Detailing for Gabapentin

Affairs Medical Center, San Francisco, California, United States of America.
PLoS Medicine (Impact Factor: 14.43). 05/2007; 4(4):e134. DOI: 10.1371/journal.pmed.0040134
Source: PubMed


Sales visits by pharmaceutical representatives ("drug detailing") are common, but little is known about the content of these visits or about the impact of visit characteristics on prescribing behavior. In this study, we evaluated the content and impact of detail visits for gabapentin by analyzing market research forms completed by physicians after receiving a detail visit for this drug.
Market research forms that describe detail visits for gabapentin became available through litigation that alleged that gabapentin was promoted for "off-label" uses. Forms were available for 97 physicians reporting on 116 detail visits between 1995 and 1999. Three-quarters of recorded visits (91/116) occurred in 1996. Two-thirds of visits (72/107) were 5 minutes or less in duration, 65% (73/113) were rated of high informational value, and 39% (42/107) were accompanied by the delivery or promise of samples. During the period of this study, gabapentin was approved by the US Food and Drug Administration only for the adjunctive treatment of partial seizures, but in 38% of visits (44/115) the "main message" of the visit involved at least one off-label use. After receiving the detail visit, 46% (50/108) of physicians reported the intention to increase their prescribing or recommending of gabapentin in the future. In multivariable analysis, intent to increase future use or recommendation of gabapentin was associated with receiving the detail in a small group (versus one-on-one) setting and with low or absent baseline use of the drug, but not with other factors such as visit duration, discussion of "on-label" versus "off-label" content, and the perceived informational value of the presentation.
Detail visits for gabapentin were of high perceived informational value and often involved messages about unapproved uses. Despite their short duration, detail visits were frequently followed by physician intentions to increase their future recommending or prescribing of the drug.

Download full-text


Available from: Charles Seth Landefeld, Feb 20, 2015
  • Source
    • "Although some off-label prescribing is evidence based and/or unavoidable222324, studies also show that a significant amount of offlabel use takes place without sufficient scientific evidence supporting this practice[2,25,26], and there is also evidence that off-label prescribing has caused serious harm to patients[27,28]. Despite acknowledged risks to patient safety, companies have a financial incentive to increase their market share by illicitly promoting off-label use of drugs[23,29,30], and research indicates that this promotional activity is effective in stimulating off-label prescribing[31,32]. To protect patients, it is therefore imperative that governments have robust enforcement systems in place to deter industry off-label promotion. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: European Union law prohibits companies from marketing drugs off-label. In the United Kingdom-as in some other European countries, but unlike the United States-industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. Methods and findings: We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing. Conclusion: The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.
    Full-text · Article · Jan 2016 · PLoS Medicine
  • Source
    • "GBP is also widely used for the treatment of neuropathic pain and in off-label treatments [11], all of these being chronic regimens. Since the appearance of GBP as an add-on therapy for epilepsy in 1993, many studies have aimed to determine its cognitive profile and the potential application of this drug to the management of other neurological disorders [10] [11]. Several clinical and preclinical studies have provided evidence of the negative influence of GBP on memory performance after standard administration regimens [12] [13] [14] [15]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: We previously reported that administration of a single dose of gabapentin (GBP) immediately after training improves memory of mice in an inhibitory avoidance task (IA), whereas GBP administered repeatedly for 7 days impairs memory. This is in accordance with the observation that long-term clinical treatment with GBP may be associated with adverse cognitive side effects. In the present work we used a GBP-loaded poly(epsilon-caprolactone) implant, allowing controlled release of the drug and maintenance of constant plasma levels over 1 week. When GBP-loaded implants were inserted subcutaneously into mice, immediately after training in the IA task, memory consolidation was enhanced. Moreover, GBP released from implants had an anticonvulsant action against pentylenetetrazole-induced seizures. These results suggest that maintenance of stable GBP plasma levels could protect against seizures without causing memory impairment. Hence, the adverse cognitive effects might be avoided by stabilizing plasma levels of the drug.
    Full-text · Article · Feb 2010 · Epilepsy & Behavior
  • [Show abstract] [Hide abstract]
    ABSTRACT: Publication bias, especially the lack of publication of negative treatment studies, is known to be a major problem in the medical literature. In particular, it appears that the pharmaceutical industry is not routinely making data from negative studies available through the published scientific literature. In this paper, we review the case of studies with lamotrigine in bipolar disorder, describing evidence of lack of efficacy in multiple mood states outside of the primary area of efficacy (prophylaxis of mood episodes). In particular, the drug has very limited, if any, efficacy in acute bipolar depression and rapid-cycling bipolar disorder, areas in which practicing clinicians, as well as some academic leaders, have supported its use. The negative unpublished data now made available on lamotrigine provide an important context for clinical practice and research, and also raise important scientific and public policy concerns about having access to studies showing inefficacy with psychotropic medications.
    No preview · Article · Feb 2008 · Medscape journal of medicine
Show more