A national watchdog group has called for the criminal prosecution of a Philadelphia-based pharmaceutical company after a Johns Hopkins Hospital doctor complained the company was illegally promoting a drug that had not yet received federal approval.
The Public Citizen Health Research Group charged last week that SmithKline Beecham Pharmaceuticals invited Baltimore-area doctors to three dinners at the Stouffer Harborplace Hotel last month in an attempt to blatantly promote Relafen, an arthritis drug not yet approved by the federal Food and Drug Administration.
Such dinners are arranged to familiarize doctors with a drug so that when it is approved, they will be inclined to prescribe it, said Dr. Sidney M. Wolfe, director of the national patient-advocacy group based in Washington. In addition, because there is no FDA-approved labeling specifying side effects or limitations of a drug, the company can favorably present it.
After being treated to an expensive dinner, Dr. Wolfe said,
doctors "have a fine memory of the drug when it gets out of the starting gate, when the FDA finally approves it."
Dr. Edward F. Ellerbeck, a fellow in Hopkins' Department of Medicine, said he received an invitation to attend one of three dinners on Aug. 26, 27 or 28 where, according to the invitation, he would "participate in a group discussion . . . regarding a new non-steroidal arthritis agent currently under FDA review."
The invitation reads, "Your role will be to examine and discuss the profile of this new important product (Relafen, nabumstone) and offer your suggestions on how to best communicate efficacy, safety and patient management to other physicians when this product is introduced."
"This gets tricky because it's done under the guise of marketing research," an activity permitted under the law, said Dr. Ellerbeck, who did not attend the dinners and knew of no doctor at Hopkins Hospital who had done so. "I think past experience on that type of marketing research would suggest that it's more marketing than research."
Federal law prohibits drug companies from advertising or promoting drugs that have not been approved for sale by the FDA. But companies may engage in legitimate market research, said FDA spokeswoman Faye Peterson.
"If we find that the invitation was sent out ot large numbers of physicians, it would be considered promotional activity and not legitimate marketing research," and therefore a violation of FDA guidelines, said Ms. Peterson. "And we plan to look into this immediately."
Jeremy Heymsfeld, a spokesman for SmithKline Beecham, denied that the intent of the meetings was to market the drug to doctors.
Rather, the meetings were meant "to obtain information from them [doctors] on how best to meet their needs and the needs of their patients," he said.