Vioxx study more about marketing than science, says report

The suspected practice of passing marketing studies off as scientific research has come under the microscope following the publication of a report which points the finger at Merck & Co and a 1999 study of its now-withdrawn COX-2 inhibitor Vioxx.

According to an article published in the Annals of Internal Medicine, a study of Vioxx (rofecoxib), called ADVANTAGE, is an example of a “seeding” trial, which are “designed to appear as if they answer a scientific question but primarily fulfill marketing objectives”. The process sees a company puts its product in the hands of practicing doctors, “hoping that the experience of treating patients with the study drug and a pleasant, even profitable, interaction with the company” will result in “more loyal physicians who prescribe the drug”, the report claims.

The authors of the study obtained court-ordered documents, some of which were e-mailed messages, that showed that Merck did not reveal the key role of the marketing division and marketing objectives of the study. Instead, physician-investigators, participants and institutional review board members were told that the purpose of the trial was to measure the gastrointestinal safety of Vioxx against naproxen.

The authors added that although seeding trials “may have some positive aspects”, such as education of community physicians and early access to medications for patients, “the undisclosed use of research by corporate marketing divisions threatens the integrity of the relationship of industry, academia, patients and society”. Nevertheless, they went on to say that without access to internal documents, “the intent of pharmaceutical companies in conducting clinical trials is nearly impossible to prove”.

In an accompanying editorial, the journal’s editor Harold Sox said that “by publishing this article, we hope to shine a light on a practice that appears to be widespread, that really involves an element of deception”. He added that this is one practice that “appears to put patients at risk when there may be little or no scientific benefit to the research. Indeed, some patients were injured by the drug”.

In response, Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, told the Associated Press that “the ADVANTAGE study was primarily a scientific study” and that any later use of data for marketing was a separate matter. “This is a trial that had good, scientific merit and was judged by the editors of the Annals when they accepted it for publication” originally.