Characteristics and impact of drug detailing for gabapentin
ABSTRACT 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.
Full-textDOI: · Available from: Charles Seth Landefeld, Feb 20, 2015
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ABSTRACT: The ubiquitous nature of medical conflicts of interest is attracting increased attention from physicians, policymakers, and patients. However, little work has examined the psychological processes at play in the presence of such conflicts. I investigate the subtle influences arising from conflicts of interest that change behavior in both physicians and patients. First, I explore why physicians accept gifts from pharmaceutical companies and medical device manufacturers that appear, to many critics, to be unethical. I review evidence from my published and ongoing research that demonstrates two psychological processes that enable physicians to accept industry gifts: (a) a sense of entitlement and (b) a sense of invulnerability to the biasing effects of conflicts of interest. Second, I investigate the situations that may increase or decrease bias. I find that people, subject to a financial conflict of interest, show greater bias in their advice when they feel less able to identify with the advice-recipient(s). This, perversely, leads to advisors giving more biased advice to groups of people than to one identified individual. Finally, I examine the impact of the conflicted advice on the patient and the success of policies intended to manage such conflicts. Mandatory second opinions and disclosure are often advocated as potential solutions to deal with conflicts of interest. However, both policies have limitations and can sometimes make matters worse. A primary advisor who knows about a second advisor may give even more biased advice since the presence of a second advisor undermines the relationship with the primary advisor. Also, although disclosure of a conflict of interest does have the intended effect of causing patients to trust the advice they receive less, I find that it also has an additional unintended consequence: it creates increased pressure to comply with the (distrusted) advice. This increased pressure occurs because patients want to avoid appearing as though they believe that the (now disclosed) conflict of interest has corrupted their doctors' advice. Thus, instead of being merely a warning, disclosure can become a burdensome request to comply with advice the patient trusts less. These results highlight potential pitfalls that new policies intended to address conflicts of interest should seek to avoid.The Journal of Law Medicine & Ethics 09/2012; 40(3):482-7. DOI:10.1111/j.1748-720X.2012.00680.x · 0.94 Impact Factor
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ABSTRACT: Introduction: Pharmaceutical sales visit claims of drug efficacy can influence physician prescribing. Efficacy claims may be susceptible to exaggeration in promotions for drugs approved on the basis of surrogate outcomes. They may also be different in countries with different sales visit regulations. Objectives: To compare the frequency of physician-reported claims of serious morbidity or mortality benefit in promotions for drugs approved on the basis of surrogate outcomes (where claims are unwarranted) with those approved on the basis of serious morbidity or mortality. Additionally, to compare the frequency of unwarranted claims of serious morbidity or mortality benefit by country of promotion. Methods: From 2009 to 2010, primary care physicians in Canada, France, and the United States reported via pre-set questionnaires on claims of serious morbidity or mortality benefit in consecutive cardiovascular drug promotions. Promoted drugs were either 1) approved on the basis of surrogate outcomes, or 2) approved on the basis of serious morbidity or mortality. Using generalized estimating equations, the frequency of reported efficacy claims was compared between the two promotion types. The frequency of unwarranted claims drug benefit was also compared by country. Results: 448 promotions were analyzed. Claims of serious morbidity or mortality benefit were reported in 156/347 (45%) promotions for drugs approved on the basis of surrogate outcomes and 72/101 (71%) promotions for drugs approved on the basis of serious morbidity or mortality, p<0.001. Despite stricter sales visit regulations, unwarranted claims of serious morbidity or mortality benefit for drugs approved on the basis of surrogate outcomes were reported most frequently in France (59%) compared to Canada (46%), p=0.2 or the United States (26%), p=0.02. Conclusions: Across countries, unwarranted claims of drug benefit were frequently reported in promotions for drugs approved on the basis of surrogate outcomes. These claims amount to off-label promotion and contravene national sales visit regulations.05/2015, Degree: Master of Science, Supervisor: Anne Holbrook