Researchers say Vioxx study was marketing

TRENTON, N.J. - A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits.

Drug companies are widely suspected of doing many such "seeding," or marketing studies, but there's been no "smoking gun" proving it before, according to the Annals of Internal Medicine, which published Merck's original report on ADVANTAGE in 2003 and will publish the new report today.

An accompanying editorial, co-authored by Annals editor Dr. Harold C. Sox, states the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating Vioxx was better tolerated.

Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said yesterday "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical research unit and that any later use of data for marketing was a separate operation.

But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.

The authors searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

ADVANTAGE used about 600 family doctors new to clinical research, with each getting a stipend plus fees for recruiting a handful of patients. Most clinical trials are run by specialists at major teaching hospitals that each recruit hundreds of patients.