On Sept 30, Vioxx, the popular arthritis and acute pain drug, was withdrawn from the market. The reason, as CEO of Merck & Co (manufacturer of the drug), Raymond V Gilmartin put it, ' ... was an increased relative risk for confirmed cardiovascular events such as heart attack and stroke'.
Vioxx came into the market in 1999 and since then sold in more than 80 countries including Malaysia. In 2003 alone, worldwide sales was US$2.5 billion. This sudden worldwide recall is the biggest in the pharmaceutical history.
The Wall Street Journal, Oct 6, reported that the drug has been linked to an estimated 27,785 heart attacks and sudden cardiac deaths. This report cited a study by a Food and Drug Administration (FDA) official, which was leaked.
Vioxx is a class of non-steroidal anti-inflammatory drugs (NSAIDS). In 1999, Vioxx and Celebrex, the two newer arthritic and acute inflammatory drugs, were hailed as safer. Older NSAIDS including Ibuprofen, Naproxen, Indomethacin and the popular Aspirin were known to cause side effects like gastrointestinal bleeding and ulcers.
However, as early as March 2000, the Archives of Internal Medicine suggested that congestive heart failure can be a far worse side effect than gastrointestinal damage for NSAIDS.
One year ago, the Adverse Drug Reaction Advisory Committee of Australia (Adrac) had in its October 2003 newsletter warned that common prescription drugs for arthritis, depression and epilepsy had been linked to a variety of potential adverse health effects including heart attacks, convulsions and birth defects. According to the Adrac, '... there may be an increased risk of cardiovascular and cerebrovascular disease' with Celebrex and Vioxx.
Since the shocking sudden drug recall, alarm bells have been sounded in America and Europe. Articles in the Lancet and New England Journal of Medicine mentioned the companies that produced the painkiller drugs knew of the potential risk for five years but failed to run the necessary trails to check whether the drugs posed a real danger.
On Oct 8, Reuters reported that Johnson & Johnson, the manufacturer of Remicade (another class of drug for rheumatoid arthritis), had issued a warning that patients on the drug may have a higher risk of lymphoma, a blood cancer. Other drugs of this similar class are Enbrel and Humina.
Since the worldwide drug recall of Vioxx, there have been at least four cases of individual and class action lawsuits filed in US against Mersk & Co.
The Vioxx scare could preclude an avalanche of pharmaceutical drugs lawsuits besides a global outcry for better accountability and for a better application of science for ethics and humanity.
It is also a case of a storm in the West but eerie calm in Malaysia and the East.
