Business
Email
Print
Ethical questions being raised about Merck's study of Vioxx
It 'was marketing framed as scientific research,' a researcher for plaintiffs says
AP File Photo
Plaintiffs’ attorneys are preparing for trial against Merck, which took the painkiller Vioxx off the market in 2004.
ADVERTISEMENT
Published: August 19, 2008
TRENTON, N.J. - A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.
The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its release, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing about a million Merck documents for plaintiffs' attorneys preparing for trials in Vioxx lawsuits.
Drug companies are widely suspected of doing many such "seeding," or marketing studies, but there's been no "smoking gun" proving it before, according to the Annals of Internal Medicine, which published Merck's original report on ADVANTAGE in 2003 and will publish the report today.
An accompanying editorial, co-authored by Annals editor Dr. Harold C. Sox, says that the journal was not told the true purpose of ADVANTAGE, which compared Vioxx with an older, cheaper pain reliever, naproxen, when it published results indicating that Vioxx was better tolerated.
Dr. Jonathan Edelman, the head of scientific affairs at Merck Research Laboratories, said yesterday that "the ADVANTAGE study was primarily a scientific study" designed and executed by the company's clinical-research unit and that any later use of data for marketing was a separate operation.
But Dr. Kevin P. Hill said he and colleagues, while working as paid consultants for lawyers representing plaintiffs who claimed Vioxx caused heart attacks or other harm, stumbled on documents indicating that Merck's marketing division designed ADVANTAGE and handled the data collection and analysis.
Using money from the Robert Wood Johnson Foundation's clinical-scholars program, they searched further, uncovering such items as a memo from two top Merck executives nominating the study for an internal marketing award.
"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," the memo says.
ADVANTAGE used about 600 family doctors new to clinical research, with each getting a stipend plus fees for recruiting a handful of patients each. Most clinical trials are run by a limited number of specialists at major teaching hospitals that each recruit hundreds of patients.
Vioxx came on the market in June 1999, after rival Pfizer Inc.'s Celebrex. Both makers claimed that their drug caused less cramping, diarrhea and dangerous gastrointestinal bleeding than other pain relievers. Merck battled hard for market share, and Vioxx at its peak brought in about $2.5 billion a year.
Hill, now a staff psychiatrist at McLean Hospital in Massachusetts, said he and his colleagues found documents indicating that "ADVANTAGE was marketing framed as scientific research," with an emphasis on how much Vioxx doctors in the study later prescribed. "I don't think people would be willing to (risk side effects) if they knew that the aim of a clinical trial was to boost profits for a pharmaceutical company," Hill said.
The study's name implied it had a scientific purpose: ADVANTAGE, or Assessment of Differences between Vioxx and Naproxen to Ascertain Gastrointestinal Tolerability and Effectiveness.
But Hill said that doctors participating in ADVANTAGE got a kit telling them how to talk to other doctors about Vioxx, and another Merck study running at the same time, called VIGOR, also examined how safe Vioxx was for people with gastrointestinal problems, so ADVANTAGE wasn't needed. VIGOR's results were published in 2000.
Merck spokesman Ron Rogers said that Hill and his colleagues have been critics of Merck and just cherrypicked "some documents to support their thesis."
Dr. Bruce Psaty, a University of Washington epidemiologist, said that Hill and his colleagues had disclosed their conflict of interest in their report but that the ADVANTAGE trial wasn't transparent about its purpose. "I would think that at some level, this is standard practice," he said of seeding studies, but they don't come to light except during the discovery phase of litigation.
Dr. Ross McKinney, the director of Duke University's bioethics center, said that seeding studies have been around for years and usually are called postmarketing studies, meaning they're for drugs approved for sale. He said that most never get published, but this one did because it dealt with an important scientific question, stomach tolerability, even though it was a seeding trial. But McKinney said that seeding studies make the public skeptical about enrolling in clinical studies.
"It's a serious violation of research ethics" and prevents patients from figuring out the risks and benefits of participating in the study, said Arthur Caplan, who is head of the University of Pennsylvania's medical-ethics department.
Merck, based in Whitehouse Station, N.J., pulled Vioxx off the market on Sept. 30, 2004, after its own research showed that the blockbuster arthritis treatment doubled risk of heart attack and stroke.
It has since reached a $4.9 billion settlement to end the bulk of personal-injury suits over Vioxx, and the first payments are to go out this month.
Email
Print
ADVERTISEMENT
N.C. Politics
Federal Politics
See community events or add your own! Click here!
Advertisement
