Epilepsy Drug Trial May Have Been Sales Tactic

Yale researchers gabapentin was part of a seeding trial

(RxWiki News) Yale School of Medicine researchers have discovered that a clinical trial of epilepsy drug gabapentin (trade name Neurontin) may have actually been a promotional and sales move to increase prescriptions of the medicine.

Yale School of Medicine researchers have found that a clinical trial of the epilepsy drug gabapentin may have been a "seeding trial" used by a pharmaceutical company to promote the drug and increase prescriptions, according to a report in the June issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

A seeding trial is a clinical trial primarily used to market and promote a drug by exposing doctors and researchers to it. It's not illegal, but many consider them unethical.

"Ask questions in you are involved in a clinical trial."

Yale assistant professor of medicine Dr. Joseph Ross, M.D., and his colleagues reviewed documents relating to the clinical trial "Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS)," and also company correspondence and legal documents.

Dr. Ross said the review showed that it was a clinical trial posing as a legitimate scientific study. He said the trial itself served only as a marketing strategy, and that trial patients and researchers were not informed. 

Authors of the gabapentin trial said the study's purpose was to study dosing of the drug among 2,759 patients who were enrolled by 772 investigators. Two articles were published featuring the results, but Dr. Ross said that the data quality during the study was often compromised. He noted that marketing staff appeared to be involved in data collection.

The STEPS study was conducted 15 years ago but Dr. Ross said the ethical breaches remain relevant over the limits and consequences of pharmaceutical company sponsorship of clinical trials after the drug's release. Dr. Ross' review of the study does not mean that gabapentin is unsafe or ineffective.

"The current Institutional Review Board (IRB) system needs to be reformed, and better clinical trial practice needs to be promoted in the human subjects research community in order to prevent further seeding trials by the pharmaceutical industry," said Dr. Ross.

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Review Date: 
June 29, 2011