A report appeared in the August 19 issue of the Annals of Internal Medicine reveals that a 1999 clinical trial (called ADVANTAGE or Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) of Merck & Co.’s Vioxx, was done in fact to support a marketing campaign before the drug’s launch.

Many researchers believe that such behavior, which raises ethical and scientific questions, is not singular when it comes to drug companies and their way of promoting their new recipes. Recently, an editorial in the Journal of the American Medical Association suggested the ENHANCE study of Vytorin was also done for marketing purposes, but the authors cited only circumstantial evidence for the allegation.

Patients need to know exactly the risks they are exposing to. Moreover, the researchers said the practice “threatens the integrity of the relationship of industry, academia, patients and society.”

Kevin Hill, a psychiatrist at McLean Hospital in Belmont, Mass., and colleagues base their conclusions on 100 internal company memos and reports about the study obtained from lawsuits against Whitehouse Station, New Jersey-based Merck over heart risks tied to Vioxx.

“Documentary evidence shows that ADVANTAGE is an example of marketing framed as science,” they wrote in the paper.

Vioxx generated sales of $2.5 billion a year before the arthritis and chronic pain pill was withdrawn from US drugstores almost four years ago, when a Merck study showed that long-term users had twice the risk of heart attack and stroke.

The clinical trial referred to involved 5,557 patients and started in 1999 just as Vioxx was cleared for sale, the report says. The trial used about 600 family doctors new to clinical research, which were paid by Merck for recruiting a handful of patients each.

One of the memos written by  Merck executives said: “The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class and gather data important to this customer group. The ADVANTAGE trial utilized this important group of prescribers as investigators. In addition to gaining experience with Vioxx, many of these physicians gained a highly coveted introduction to clinical research.”

The Annals of Internal Medicine published the ADVANTAGE study in 2003, without saying that some of the participants suffered cardiovascular complications.

On the other hand, Jonathan Edelman, MD, executive director of Merck Research Labs’ Global Center for Scientific Affairs denied the ADVANTAGE trial had originated with the company’s marketing division.

“ADVANTAGE was scientifically driven by [Merck’s] clinical research division,” Edelman said, adding that the report in the Annals of Internal Medicine “wrongly characterized” the study on the basis of a misinterpretation of the Merck memos. He said the trial was the first to test Vioxx against naproxen in patients with osteoarthritis.