Last week,a report in The Annals of Internal Medicine alleged that a key Vioxx study, known as Advantage, was actually a seeding study, which is a common reference to a stealth marketing effort.
The report caused a stir, partly because being able to prove seeding accusations is difficult, but also because Merck has consistently been charged with placing marketing above science in touting Vioxx, which was withdrawn in 2004 over links to heart attacks and strokes. Merck has since settled most US lawsuits for $4.85 billion.
In an accompanying editorial, the editor of The Annals of Internal Medicine, stated 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.
Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, tells the AP that “the ADVANTAGE study was primarily a scientific study” designed and executed by the drugmaker’s clinical research unit and that any later use of data for marketing was a separate operation. Here is an open letter from Merck, the amended protocol for the trial, and Merck's synopsis of the study.
Meanwhile, an e-mail thread from March 1999, the year Vioxx was launched, captures a conversation among Merck marketing people as they decide how to handle the Advantage trial. Notice that one wrote: "I eliminated the reference to seeding. It may be a seeding study, but let's not call it that in our internal documents." So... was it a seeding study or not?
We asked a Merck spokesman for a response to the e-mail and this is what came back: "Some non-scientists in the company used the term 'seeding study' to describe the fact that one aspect of the study was that it enabled a large group of investigator physicians to gain familiarity with the product in the context of a rigorous study. This does not change the fact that this study had a significant scientific purpose and a rigorous methodology.
"Merck disagrees with the characterization of Advantage as a 'seeding study' and with the conclusions of the journal article. The company firmly believes there is great value in understanding questions physicians want answered and in conducting rigorous, scientific clinical studies to address those questions.
"The Advantage clinical trial was designed, conducted, analyzed, interpreted and published by the scientific arm of Merck's US Human Health (USHH) organization, Clinical Development (CDP), in conjunction with participating investigators. CDP was part of medical and scientific affairs department of USHH and was a separate from the marketing department within USHH. Merck Research Laboratories’ Clinical Research Review Committee exercised oversight.
"The (Annals report) authors, consultants hired by plaintiffs’ lawyers, erroneously claim that the objectives of the Advantage study were not scientific, based on their limited selection of documents produced in the VIOXX litigation. They purposely fail to distinguish between the dual scientific research and marketing functions of USHH."
In case you missed it, here is an interview with one of the authors of the Annals report.