In e-mail messages on April 7, 2001, to … an executive vice president at Merck Research Laboratories, [President of Merck Research Labs] Dr. [Edward] Scolnick wrote that he was especially angry because the Advantage trial had no scientific purpose. In theory, Merck set up the trial to show that Vioxx caused fewer stomach problems than naproxen. But Merck had already demonstrated that with the Vigor trial, which tracked more than 8,000 patients for a year.
… [T]he reason we have resisted doing large marketing clinical studies is just this. It opens a lot of data to FDA that compromises the large clinically meaningful trials.” Small marketing studies which are intellectually redundant are extremely dangerous,” Scolnick wrote.

If a pharma company does not listen to its head of R&D, then who will it listen to?

However the marketing division had it’s own independent physicians who designed and conducted studies for the express purpose of marketing and these were not designed for any regulatory purpose.

Studies that have no scientific merit are not uncommon in the pharmaceutical industry. FDA generally won’t object to unethical studies if an institutional review board signs off on it and IRBs usually won’t make waves because once you do you can kiss future studies and $ goodbye. If an IRB has a problem they might ask if it’s been reviewed by FDA but since most studies that are submitted aren’t reviewed and especially not marketing studies it’s a big farce.

Salmon

In my experience, marketers often try to push the envelope on studies; their opinions should be counterbalanced by their peers from Medical and Legal/Regulatory. If everything works, robust studies get conducted that meet medical gaps and marketing needs. By only looking at the emails from marketers, I feel as though I am only seeing part of the story.

One more note…this study was conducted in the late 1990s. In most major pharma companies, a “seeding” study would be highly unlikely to pass internal scrutiny today.