Drug Trial Raises Ethics Questions

Drug Trial Raises Ethics Questions [New Haven Register, Conn.]

From New Haven Register (CT) (June 28, 2011)

June 28--NEW HAVEN -- A clinical trial for Neurontin, a popular epilepsy drug, may have been undertaken purely to promote the medication, rather than to test how well it worked, according to a report by a Yale School of Medicine professor.

The paper, published Monday in the Archives of Internal Medicine, found that the trial for the drug, known generically as gabapentin, appeared to be a "seeding trial," in which many doctors were recruited so that they would be more likely to prescribe the drug.

The trial, known as STEPS for "Study of Neurotonin: Titrate to Effect, Profile of Safety," was undertaken by the pharmaceutical company Parke-Davis, then owned by Warner-Lambert but later bought by Pfizer.

"The company monitored the prescribing patterns before and after the study," said Dr. Joseph Ross, assistant professor of medicine at the Yale Medical School. "They were studying the impact of being an investigator in the study, not (of) being a patient."

A "seeding trial" is not illegal, but it is unethical, Ross said, because it is posing as a medical trial, but is in fact seeking to market the drug.

Normally, Ross said, clinical studies involve a small number of doctors. In the STEPS study, however, Parke-Davis signed up 772 investigators, who enrolled 2,759 patients, fewer than four each.

Ross said he hopes the report will lead to better oversight of clinical trials and more scrutiny of corporate-sponsored trials.

The report was based on documents released as a result of two lawsuits against Warner-Lambert and Pfizer, including reports, correspondence and emails, Ross said.

Neurontin, an anti-convulsant, is used to control seizures, but also can be prescribed to relieve nerverelated pain, such as from shingles, according to the website PubMed Health.

In response to a request for comment, Pfizer issued a statement saying, "Neurontin is an important FDA-approved medicine that physicians have prescribed to treat millions of patients safely and effectively."

This is not the first time the marketing of Neurontin has come under scrutiny. In 2004, Pfizer agreed to pay $430 million and pleaded guilty to criminal charges of promoting off-label uses for Neurontin.

A drug may only legally be marketed for uses that have been approved by the U.S. Food and Drug Administration, although it is legal for doctors to prescribe a medication to treat other conditions.

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Posted: June 2011


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