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.
Methods and Findings
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.
Visits from pharmaceutical representatives regarding gabapentin "detailing" were frequently followed by physician intentions to increase their future activity with the drug.
In the US, before a pharmaceutical company can market a drug to doctors for use in a specific “indication” (meaning the treatment for a particular disease and group of patients), the drug has to be approved as safe and effective for that use by a government agency, the Food and Drug Administration. Once approved, doctors are allowed to use a drug for whatever nonapproved indications they think are appropriate, but the drug company cannot actively promote the drug for anything other than its approved use. However, many people are concerned that drug companies indirectly try to promote use of drugs for indications that are not approved. Such illegal activity would help a drug company increase its market share and sell more drugs. One tactic that drug companies use to sell drugs is “detailing.” Detailing involves direct visits from drug company representatives to individual doctors, during which the representative would provide information about their company's drugs. However, not a great deal is known about detail visits and the effect that they have on doctors' attitudes towards the drugs that are being promoted.
Why Was This Study Done?
The researchers carrying out this study wanted to learn more about what happens during detail visits and what impact these visits have on prescribing behavior. An opportunity for researching this came about as a result of a lawsuit during which drug company documents were subpoenaed (i.e., required by the court to be made available). In that lawsuit, it was alleged that a drug company, Parke-Davis, had promoted a drug, gabapentin, for many nonapproved uses. The company that subsequently took over Parke-Davis eventually made an out-of-court settlement. During the relevant time period, the only approved use of gabapentin was for treatment of partial seizures in adults with epilepsy, in combination with other drugs. However, gabapentin was used for many other conditions such as treatment of psychiatric disorders and management of pain. These researchers therefore used the documents available as a result of the lawsuit to research detailing and what impact detailing had on doctors' attitudes towards the drug being promoted.
What Did the Researchers Do and Find?
The documents analyzed in this study were produced by Verispan, a market research company. Verispan asked doctors who had been visited by Parke-Davis sales representatives to fill out a standard form after each detail visit. These forms were then subpoenaed as part of the lawsuit against Parke-Davis. The researchers here focused specifically on data relating to visits made by a single sales representative to a doctor or small group of doctors, and collected 116 forms. The data available from these forms included the doctors' ratings and comments regarding the main message associated with the products; the informational value of the visit; the quality of the presentation; and whether the doctor currently prescribed or planned to prescribe the product. The researchers classified the information available from the forms, identifying whether the “main message” related to approved uses of the drug or not; and extracting data relating to whether doctors planned to increase, maintain, or decrease their use of the drug. The majority of the visits studied were to doctors who were not neurologists, and would therefore be unlikely to prescribe gabapentin for its approved use. Doctors reported that a substantial proportion of the detail visits contained messages relating to nonapproved uses of gabapentin. Nearly half the doctors stated in the forms that their use of gabapentin would increase in the future, and no doctors said that their use would decrease following the visit. Doctors' intention to increase their use of gabapentin in the future was similar regardless of whether the message of the visit involved an approved or unapproved use.
What Do These Findings Mean?
This study shows that in the case of gabapentin, detail visits by drug company representatives frequently promoted nonapproved uses of the drug; these visits often resulted in doctors planning to increase their use of gabapentin. However, it is not clear whether these findings are also true for other drugs and drug companies, in part because these data came about as a result of a unique opportunity granted by the lawsuit against Parke-Davis.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040134.
Medline Plus (provided by the US National Library of Medicine) has an entry about gabapentin
Introductory information is available from the US FDA Center for Drug Evaluation and Research about the drug approvals process in the USA
Wikipedia has an entry on pharmaceutical marketing (Note that Wikipedia is an internet encyclopedia anyone can edit)
The Drug Industry Document Archive is available at University of California, San Francisco; this internet archive holds documents relating to the lawsuit against Parke-Davis and from which the data presented in this paper derives
Guidance is available from the International Federation of Pharmaceutical Manufacturers and Associations regarding ethical promotion of medicines