A Vioxx study that was supposedly meant to find out if the recalled painkiller was less likely to cause stomach problems than another drug was really nothing more than a marketing ploy, a new report says. According to Merck & Co. memos and reports obtained during Vioxx lawsuits, the Advantage study was crafted by Merck’s marketing department to get physicians to prescribe Vioxx. What’s worse, when the study was published, it omitted information about patients who had suffered cardiovascular problems while enrolled in the trial.
Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The Vioxx recall led to thousands of lawsuits.
The report on the Advantage study was compiled by researchers working as paid consultant for lawyers who were suing Merck for Vioxx injuries. The Advantage study compared Vioxx to naproxen when given to patients already taking aspirin. The purpose of enlisting nearly 600 doctors in the Advantage study was to boost their confidence in the new drug and get them to promote it to colleagues, the report said.
According to internal Merck documents, the Advantage study was called a “seeding trial”. The Merck marketing executives who were in charge of the study were nominated for the company’s “Best Physician Program Award.” According to the award memo, the executives were nominated because the physicians who participated in the study prescribed Vioxx much more often than other doctors.
The original Advantage study was published in the Annals of Internal Medicine in 2003. A later analysis found several patients suffered cardiovascular complications that weren’t reported in the original trial. That omission makes the study even more disturbing.
According to the authors of the Vioxx Advantage report, using seeding trials to market drugs is not an unusual practice. But such a trial is a “moral offense,” the authors wrote, because there is no way for people outside of the drug company to know the study’s true intent.
This is not the first time Vioxx trials run by Merck have raised serious ethical questions. In April, it was learned that Merck concealed mortality risks in two key Vioxx studies, and hired “ghostwriters” to author research that was supposedly conducted by independent scientists. According to articles that appeared in the April issue of the “Journal of the American Medical Association”, an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck employees worked alone or with publishing companies to write study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. In many cases, Merck’s involvement in producing the data wasn’t disclosed.
Merck also used its control over Vioxx studies to manipulate the data so that it favored the now-recalled drug. One of the JAMA articles says that in 2001, Merck had data that Vioxx patients in two Alzheimer’s studies had a higher death rate than patients on dummy pills. Merck didn’t publicize that “in a timely fashion” and provided information to the FDA that downplayed the deaths, the report said.