Illegal Marketing of Neurontin DetailedJan 8, 2009 | Parker Waichman LLP
An article detailing the marketing of Neurontin recently published in the New England Journal of Medicine (NEJM) sheds new light on the tactics used by drug makers to increase sales of their products. In the case of Neurontin, these methods were uncovered because they were being used to illegally promote off-label uses of the drug. However, the authors of the NEJM article contend that the same questionable tactics are regularly used to promote approved of uses of drugs.
Neurontin was approved by the U.S. Food & Drug Administration (FDA) in 1983 to treat partial complex seizures. The drug quickly became a blockbuster, and by 2004, sales reached $3 billion per year. Neurontin was made by Parke-Davis, a division of Warner-Lambert, which was acquired by Pfizer in 2000.
In 2004, Warner-Lambert pled guilty and agreed to pay $430 million to resolve charges that it had illegally promoted the off-label use of Neurontin. The charges stemmed from a federal whistleblower lawsuit that had claimed Neurontin marketing was promoting off-label uses, including the treatment of pain and bipolar disorder. While doctors are free to use approved drugs in anyway they see fit, promoting off-label uses (those not yet approved by the FDA) is illegal.
According to the NEJM, the case that prompted Warner-Lambert's guilty plea made a treasure trove of corporate documents public. They revealed that the Neurontin marketing strategy had two prongs. The first included the promotion of the drug among high prescribing physicians, as well as the cultivation of so-called "thought leaders" - highly-regarded physicians and researchers whose opinions can influence other doctors.
This strategy involved recruiting physicians to talk up the off-label uses of Neurontin to their peers, something known as "peer-to-peer" selling. The NEJM article also says that academic leaders were plied with educational and research grants, as well as lucrative speaking opportunities, to encourage them to promote Neurontin. Many were also invited to be part of "advisory boards" or paid as "consultants" so the drug maker could "cultivate relationships with them and deliver a 'hard hitting message about Neurontin'".
The drug maker also produced or funded education, publications and research that promoted Neurontin, but whose promotional intent was disguised, the NEJM said. For instance Parke-Davis formed speakers bureaus that used "strong Neurontin advocates" to promote the drug. For-profit medical-education companies were given grants to produce "educational" programs to tout off-label use of Neurontin. These same types of companies were also paid to produce articles - under the names of authors chosen by Parke-Davis - that were designed to achieve promotional goals. Research was also designed and commissioned to promote Neurontin, the NEJM said.
The most disturbing aspect of the Neurontin marketing saga is the number of people and institutions needed to pull it off. According to the NEJM, the strategy required the complicity of highly regarded hospitals, universities, researchers and doctors. Even the FDA failed to intervene until the true scope of the promotional program was made public by the whistleblower lawsuit. Until then, the NEJM says, the tactics used to market Neurontin were seen by these individuals and institutions as "business as usual".
While the activities used to promote off-label use of Neurontin may seem shocking, they are hardly unusual. As the NEJM article points out, they only came to light in this case because they were being used to illegally promote non-approved uses of the drug. Similar strategies are often used to promote the approved uses of drugs, but because this marketing is legal, the public never knows.