Neurontin study was a sham designed to boost drug sales, researchers say in medical journal
The maker of Neurontin disguised an effort to promote the anti-seizure drug to physicians as a clinical trial and failed to inform involved physicians and patients, according to a new analysis published Monday in the Archives of Internal Medicine journal.
That conclusion was based on an analysis of internal corporate documents that companies involved in marketing Neurontin, including the drug’s current owner, Pfizer Inc., were required to be disclosed in litigation. The authors of the analysis in the Archives of Internal Medicine include paid consultants to plaintiffs in litigation over the drugmaker’s promotion of Neurontin for off-label indications.
After the U.S. Food and Drug Administration approved Neurontin for epileptic seizures, the company launched what it presented as a dosing study to institutional review boards and physicians participating in the Neurontin trial, according to the Archives of Internal Medicine article.
In fact, the Archives of Internal Medicine article says, the study was a “seeding trial” aimed at introducing the drug to physicians, inducing them to prescribe it and increasing the prescribed dosages. The initiative also was aimed at fending off efforts by a competitor to introduce a rival drug, according to the Archives of Internal Medicine study. “Marketing was extensively involved in its planning and implementation,” the article in Archives of Internal Medicine says.
In a statement released Monday, Pfizer said: “Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively. Neurontin has been widely studied for more than two decades and there is an extensive body of publicly available literature on its safety and its use.”
According to the Archives of Internal Medicine article, the company sent letters to about 5,000 physicians, ultimately recruiting 1,542 to attend a study briefing simulcast at nine regional centers throughout the United States, where “promotional information about gabapentin [the active ingredient in Neurontin] was also presented.”
Sales representatives rewarded physicians for meeting goals for signing patients, including a free lunch for recruiting three patients and a free dinner for seven patients, the article says, citing a company memo. One company analysis found that prescriptions increased 38% and doses increased 10% after physicians attended an event introducing the study.
Contentions of purported seeding trials are rare. Detailed documentation has come out only in one other case, which also was disclosed through litigation.