Vioxx Study Exposed As a Marketing Ploy
By Gerri Elder
Researchers have reported that the 1999 study of Vioxx by its manufacturer, Merck & Co., was done primarily as a marketing stunt.
The Merck & Co. study of the prescription drug Vioxx was represented to participating doctors and patients as an experiment to determine whether or not Vioxx caused fewer stomach upsets than another drug.
The study compared Vioxx to an older and cheaper pain reliever, naproxen, and the published results stated that Vioxx was better tolerated.
Now internal Merck memos have been uncovered, showing that the company's ADVANTAGE study was actually a strategy to get many doctors and patients in the habit of prescribing and using Vioxx. This marketing strategy was employed just before the drug's official launch.
The Merck memos outlining the true purpose of ADVANTAGE were discovered during the process of examining approximately a million Merck documents. These documents were being scrutinized for personal injury lawyers who are representing patients who were injured by the defective drug. The discovery is a windfall for lawyers who are now preparing for upcoming trials in Vioxx lawsuits.
The Associated Press reported that drug companies have long been suspected of seeding the market, but until now there has been no concrete proof of this unethical practice.
The Annals of Internal Medicine published Merck's original report on the ADVANTAGE study in 2003 and will now publish a new report on the study. Annals editor Dr. Harold C. Sox co-authored an accompanying editorial for the new report. The editorial states the journal was not made aware of the true purpose of the ADVANTAGE study.
After the original memos were discovered and the purpose of the ADVANTAGE study was discovered, other documents were found showing that Merck's marketing division designed the study and handled the data collection analysis. A deeper dig into the documents revealed a memo from two top Merck executives that nominated the study for an internal marketing award.
One memo plainly states that one of the primary objectives of ADVANTAGE was to "provide product trial among a key physician group to accelerate uptake of Vioxx."
Approximately 600 family doctors new to clinical research were selected for the ADVANTAGE program. Each doctor was given a stipend plus fees for recruiting patients for the study. This was unique, as most clinical trials are conducted by a limited number of specialists at major teaching hospitals.
Despite the evidence to the contrary, Dr. Jonathan Edelman, head of scientific affairs at Merck Research Laboratories, defends the study and says that ADVANTAGE was primarily a scientific study. Edelman claims that it was designed and executed by the clinical research unit at Merck and that any later use of the data for marketing was a separate operation.
Vioxx was launched in June 1999 and rivaled Pfizer Inc.'s drug, Celebrex. Both drug manufacturers made claims that their drug was better tolerated by patients than other pain relievers. At its peak, Vioxx brought in approximately $2.5 billion a year for Merck.
Vioxx was taken off the market on September 30, 2004 after research by Merck showed that the drug doubled the risk of heart attacks and strokes. The company has reportedly reached a $4.85 billion settlement to resolve a large number of the personal injury lawsuits that were filed as a result of the deaths and injuries caused by Vioxx.
The newly discovered Merck documents will likely be introduced as evidence in the upcoming Vioxx personal injury cases.