Three months ago, the painkiller Vioxx? was pulled from the World Wide Market.
On Sept 30, 2004 -- Merck & Co announced that it was pulling its popular arthritis and pain drug Vioxx (rofecoxib) from the worldwide market after a clinical trial showed that the drug carried an increased risk for heart attacks and strokes
The increased cardiovascular risk was discovered during a trial to evaluate the effect of Vioxx in preventing recurrence of colorectal polyps. After 18 months of treatment, the patients taking Vioxx were found to be at greater risk for heart attack and stroke compared with those taking a placebo. All trials were stopped.
Vioxx is a COX-2 selective nonsteroidal antiinflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as Ibuprofen and Naproxen.
***A the time of the above announcement Merck's shares went down as a result. But little else.***
But now 3 months later Dr David Graham an American FDA employee, has vowed to publish research that suggests that up to 139,000 Americans alone have died, or been seriously injured as a result of taking the drug.
In an interview with the UK's Financial Times today (Jan3 '05. displayed as front page news) Dr Graham said he was determined to go ahead with publication of his updated analysis, even though he had been threatened with dismissal by the FDA if he wrote or published his updated paper.
He reminded the FT that he published a prelim: paper back in August '04 when he stated that 28,000 Americans, had died or suffered debilitating heart attacks as a result of taking Vioxx since it was first approved in 1999.
It was this first paper that forced Merck & Co and regulators to call into doubt the safety of all of the cox-2 inhibitor class of drugs that Vioxx belongs.
In view ofhis threatened dismissal and malignment Dr Graham stated that his paper is liable to be published in the British Medical Journal "The Lancet".
He also reminded listeners that he originally provided the estimates that 89,000-139,000 Americans had been seriously affected by the drug to a Congressional hearing last month.
***I can only admire this scientist, who has put his job and future on the line, endeveouring to publish certain facts, as he researched them. In order to bring supressed facts out to the general public. I wish we had more like him.***
