MSD’s Vioxx replacement study draws critics

Research into Arcoxia, developed by Merck Sharp & Dohme (MSD) as a replacement for the painkiller Vioxx, which was earlier withdrawn by the company, has received criticism for being unfair and flawed.

Associated Press reports that some have criticised the trials for testing the new drug against diclofenac – a drug known to raise the risk of heart problems – with claims that a fairer, more effective testing method would involve comparing the new substance against a drug not known to result in such complications.

Vioxx, a cox-2 inhibitor indicated for arthritis, was withdrawn from sale in September 2004 due to fears regarding the safety of the compound. Arcoxia is also a cox-2 inhibitor that is aimed at pain relief while being easy on the stomach.

Dr Steven Nissen, cardiologist at the Cleveland Clinic, told the news agency: “The development program for Arcoxia is fatally flawed. My advice to the Food and Drug Administration is that they should not approve this drug.”

Research to be published in the British-based journal The Lancet found a “statistically similar” incidence of heart problems in those using Arcoxia and diclofenac, with a lower rate of gastrointestinal problems in those using the newer drug, Associated Press notes.

Arcoxia contains the non-steroidal anti-inflammatory drug etoricoxib and is used for the treatment of acute gout, rheumatoid arthritis and osteoarthritis.