The all-expenses-paid trips to resorts in Puerto Rico and Florida for doctors and their spouses, complete with cruises, spa treatments, cash payments, and other perks were organized by Parke-Davis under the guise of advisory board, consultant, and speaker training meetings. But the real purpose of the trips was to induce doctors to prescribe Neurontin for off-label uses and to recommend it to others. In other words, the trips were kickbacks under federal law.

Those are some of the charges made in a whistleblower suit against Parke-Davis, according to court documents.

“People who have any responsibility for implementing the Office of Inspector General's [pharmaceutical marketing] guidance need to know about the Parke-Davis case, because I think it is a grocery list of the issues that the guidelines are intended to prevent,” said James Sheehan, assistant U.S. Attorney, chief, civil division, Eastern District of Pennsylvania, Philadelphia. Sheehan, who has litigated a number of prescription drug cases, made his remarks during the National Pharma Congress Audioconference held in September. The purpose of the conference, which was sponsored by the Pharmaceutical Compliance Forum, was to provide practical strategies for implementing the OIG guidance.

Consulting arrangements, such as the ones under investigation in the Parke-Davis case, are spotlighted as a high-risk area in the guidance. Sheehan, who clarified that he is not working on that specific case, explained the perspective federal prosecutors bring to these investigations. “Some companies have boards of consultants giving advice on how to sell the same product in 75 cities around the U.S. Each board has five people and they all meet in nice restaurants and they all get a nice check. It sure looks to me an awful lot like buying your marketshare.” He added that in white-collar crime, consultations are common vehicles for bribes, and that prosecutors bring that background to drug kickback cases.

For more information, watch for the December issue of Medical Meetings.