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arthritis and chronic pain pill was withdrawn from US drugstores almost four years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.