Merck is back in the media glare for alleged shady practices this week. This time round it’s for a sneaky trick known as ‘a seeding trial’: you pay for a randomized trial to get hundreds of doctors using your new drug.

“This practice—a seeding trial—is marketing in the guise of science,” write Harold Sox and Drummond Rennie, in an editorial in Annals of Internal Medicine. “The apparent purpose is to test a hypothesis. The true purpose is to get physicians in the habit of prescribing a new drug.”

In that journal researchers – led by Kevin Hill, of McLean Hospital, Belmont – use documents obtained through litigation to analyse the ADVANTAGE trial of drug Vioxx and to show that it was “designed and executed” by Merck’s marketing division. These documents have previously been the source of other damaging allegations against Merck (see this Nature story).

The researchers’ paper notes:

Although billed as a gastrointestinal safety study, ADVANTAGE was actually a sophisticated marketing tool designed to allow optimal “seeding” of positive experiences with Vioxx among customers—primary care physicians—before its approval. As a result, 5557 participants received Vioxx and 600 investigators prescribed it just before it became available on the market, which generated positive publicity and anecdotes from physicians and patients

…

Such trials may provide incremental scientific benefit: ADVANTAGE affirmed the increased cardiac risk for Vioxx compared with naproxen, which was originally seen in the VIGOR trial, although the number of cardiovascular events was misreported in the original publication. However, the primary marketing objectives of seeding trials are hidden from the public, the medical profession, and institutional review board members, preventing them from making a fully informed decision about the balance of benefits and harms to themselves and society.

As the editorial by Sox and Rennie points out:

Why would a drug company go to the expense and bother of conducting a trial involving hundreds of practitioners—each recruiting a few patients—when a study based at a few large medical centers could accomplish the same scientific purposes much more efficiently? The main point of the seeding trial is not to get high-quality scientific information: It is to change the prescribing habits of large numbers of physicians.

Bloomberg talked to one doctor who took part in the study, although he did not recall it. Conrad Butwinick, an internal medicine physician in St. Paul, Minnesota, said: “If I had sensed that there was an ulterior motive, for physicians to have an amplified experience with the drug, I would have never done that. I can’t tell you that it didn’t go on, but I would never go for that.”

Merck says ADVANTAGE was all about the science. Jonathan Edelman, a senior official at Merck Research Laboratories, told the WSJ health blog: “This is a trial that had good, scientific merit and was judged by the editors of the Annals when they accepted it for publication.”

Media coverage

Merck Vioxx study was for marketing –researchers – Reuters

Report Says Merck Vioxx Study Aimed at Marketing – WSJ

Merck Vioxx Trial Was Strategy to Boost Sales, Researchers Say – Bloomberg

Researchers: Merck Vioxx study was for marketing – AP

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