Vioxx painkiller study a “seeding project” claim US researchers

Reuters has reported that a 1999 clinical study carried out by Merck, ostensibly to test side effects of its now-withdrawn painkiller Vioxx, was done primarily to support a marketing campaign before its launch, according to researchers.

The real aim of the study, named ‘ADVANTAGE’, was to promote prescription of the new medicine when it became available -- a so-called "seeding" project -- U.S. researchers have claimed.

The research team based their conclusions on an extensive trawl of Merck internal and external documents collected by plaintiffs' lawyers preparing for Vioxx lawsuits.

"Documentary evidence shows that ADVANTAGE is an example of marketing framed as science," they wrote in the journal Annals of Internal Medicine.

Kevin Hill, a psychiatrist at McLean Hospital in Belmont, Mass., US, and colleagues said the findings showed how studies masquerading as clinical science could be used to bolster marketing plans.

"Failure to disclose the primary purpose of a trial has ethical ramifications for patients, physicians and the design of clinical trials," they said.

"Seeding trials like ADVANTAGE, in which the study medication has yet to receive FDA (U.S. Food and Drug Administration) approval, may cause patient injury for marketing purposes."

Merck spokesman Ron Rogers said Hill and his colleagues have been critics of Merck and just cherrypicked "some documents to support their thesis."

Vioxx generated sales of $2.5 billion a year before the arthritis and chronic pain pill was withdrawn from U.S. drugstores almost four years ago, when a Merck study showed that long-term users had twice the risk of heart attack and stroke. 

Last year the company took a pretax charge of $4.85 billion for a proposed settlement with U.S. patients or their survivors who had filed Vioxx product liability lawsuits against it.