Researchers studying Merck & Co internal documents conclude the drug giant's 1999 clinical study of possible side effects from its painkiller Vioxx was in actuality a pre-launch marketing campaign for the drug.
Merck was forced to withdraw the prescription drug in 2004 after tests linked it to increased risk of heart attack and stroke. The researchers outline their case against Merck in the latest issue of the Annals of Internal Medicine.
"Documentary evidence shows that Advantage is an example of marketing framed as science," they wrote.
The team gathered documents collected by plaintiffs' lawyers in the personal injury and liability lawsuits filed against the pharmaceutical company. The researchers claim the real purpose of the study, called Advantage, was to promote the drug as an arthritis treatment when it became commercially available.
Vioxx received FDA approval not long afterward and it quickly became one of Merck's most profitable products.
In their report, Kevin Hill of McLean Hospital in Massachusetts, and colleagues, said the practice of "seeding" the drug with a marketing study, disguised as science, raises a number of ethical issues.Merck takes strong exception to the researcher's conclusions, and denies Advantage was a "seeding" project. It said the study in question compared Vioxx with another medication in its effect on stomach upset. It also said the article contained "numerous inaccuracies."
Merck faced a flurry of litigation over Vioxx. After insisting it would contest each of the thousands of product liability lawsuits over Vioxx, Merck agreed in November 2007 to settle claims over the withdrawn painkiller for $4.85 billion.
The cases were filed in connection with Vioxx's removal from the market, with plaintiffs charging the company should have acted sooner. More than 27,000 consumers or their family members filed suit against Merck as a result. In the last three years, only a handful of the cases had gone to trial.
