A paper published in the August 19 issue of Annals of Internal Medicine says a 1999 study done by Merck & Co., Inc. for its now-withdrawn painkiller Vioxx is “an example of marketing framed as science.” The journal first published results of the trial, known as ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), in 2003.
ADVANTAGE is labeled as a seeding trial by the authors of the August 19 paper, who define seeding trials as “clinical studies conducted by pharmaceutical companies that are designed to seem as if they answer a scientific question but primarily fulfill marketing objectives.” Those objectives are to familiarize doctors and patients with the drug during the course of the trial in hopes they will recommend it to their peers…with the goal of boosting sales.
The authors write that the ADVANTAGE study was designed by Merck’s marketing department, that both marketing and scientific data were collected and handled by marketing, and that participants, physician investigators, and institutional review board members were not told about the “marketing nature of the trials.”
Harold C. Sox, editor for Annals, says the journal was never told “the true purpose” of ADVANTAGE, and did not know it when the study was published in 2003, according to a recent editorial written with Journal of the American Medical Association Deputy Editor Drummond Rennie. Seeding trials to promote a new drug were long suspected of taking place in the industry, but until now there was little documentation to support details of their use, according to the editors.
The authors of the August 19 paper gathered their information from their work for plaintiffs’ lawyers involved in personal-injury lawsuits against Merck from using Vioxx. One document cited in the paper as a Merck marketing memo says the study was “designed and executed in the spirit of the Merck marketing principles” and nominated the study for an internal marketing award.
Merck rejects the idea that this was a marketing operation. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, said the study was designed and carried out by the company’s clinical research unit, according to a Bloomberg article. “The documents included in this article include an example of the marketing use for the data,” he says. “The allegation by the authors that the primary goal of the study was marketing is simply wrong.”
Merck withdrew Vioxx in 2004 because of a possible link of its use with heart disease.