A report published in the Archives of Internal Medicine claims that a post-approval study investigating Pfizer's Neurontin (gabapentin), which was presented to institutional review boards and physicians as a dosing study,
was in fact a "seeding trial" designed to "promote…and increase prescribing" of the epilepsy drug.
The STEPS trial, which examined published trial results and related company documents

such as research reports, marketing analyses and internal communication between Pfizer employees,

was conducted by scientists who included paid consultants to plaintiffs in litigation over Pfizer's promotion of Neurontin for unapproved uses in the US. According to the report

 

Pfizer recruited 1542 doctors to attend a briefing on the dosing study

where "promotional information about [Neurontin] was also presented

 

Documents showed that physicians were rewarded for meeting goals for signing patients, the researchers noted,

and a company analysis suggested that prescriptions increased 38 percent and doses increased 10 percent after doctors attended an event introducing the study

The authors of the report said that two published studies resulted from the research,

and both were "generally supportive" of the drug. Lead author Joseph Ross remarked that seeding trials are "nearly impossible to identify, and that's what makes this such a challenge.

" He noted that the goal of the analysis was not to "call out" individuals at the drugmaker or doctors who were involved in the Neurontin study. "It's more about,

'how can we use this information to improve practice going forward?

How can we all come together and realise that trials for promotion and marketing purposes aren't science?'" Ross remarked.

In an accompanying editorial, G. Caleb Alexander noted that although this kind of post-approval study "serves a really important purpose,

 

" and it's difficult to determine how frequently companies distort such work for use as a marketing tool. "The greatest ethical breach with respect to patients is [that] patients were recruited for a study without the ability for adequate informed consent," he added

In January, Pfizer was ordered to pay a fine of $142.1 million related to improper marketing of Neurontin for unapproved uses in the US. The company faces more than 300 additional suits related to the off-label promotion of the product or for not disclosing the drug's health risks