Neurontin was approved for the treatment of partial seizuresÂ in epilepsy but was increasingly used forÂ pain managementÂ due to doctors beingÂ illegally influenced by a drug company.
Drug company representatives frequently promoted non-approved uses of the drug gabapentin (Neurontin) to doctors and these visits often resulted in doctors planning to increase their use of gabapentin (Neurontin).
In the US, before a pharmaceutical company can market a drug to doctors for use in a specific â€œindicationâ€ (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 non-approved 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 â€œdetailing.â€ 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.
Steinman and colleagues at The University of California, San Francisco (UCSF) wanted to learn more about what happens during “detail” visits from drug company representatives and what impact these visits have on the prescribing behavior of doctors.
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 (Neurontin), for many non-approved 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 (Neurontin) was for treatment of partial seizures in adults with epilepsy, in combination with other drugs.
However, gabapentin (Neurontin) was used for many other conditions such as treatment of psychiatric disorders and management of pain.
The researchers 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.
The documents analysed 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 â€œmain messageâ€ 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 (Neurontin) for its approved use.
Doctors reported that a substantial proportion of the detail visits contained messages relating to non-approved uses of gabapentin (Neurontin).
Nearly half the doctors stated in the forms that their use of gabapentin (Neurontin) 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 (Neurontin) in the future was similar regardless of whether the message of the visit involved an approved or unapproved use.
This study shows that in the case of gabapentin (Neurontin), detail visits by drug company representatives frequently promoted non-approved uses of the drug; these visits often resulted in doctors planning to increase their use of gabapentin (Neurontin).
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.
Steinman MA, Harper GM, Chren MM, Landefeld CS, Bero LA (2007) Characteristics and Impact of Drug Detailing for Gabapentin. PLoS Med 4(4): e134 doi:10.1371/journal.pmed.0040134. This is an open-access article distributed under the terms of the Creative Commons Attribution License. Published: April 24, 2007. Academic Editor: Steven E. Hyman, Harvard University, United States of America.
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