140000 Americans injured by Vioxx

The arthritis drug Vioxx could have caused an estimated 88,000–140,000 excess cases of serious coronary heart disease in the US since its launch in 1999, concludes a study published online by The Lancet. We had reported this earlier as well when Dr. David Graham, in an interview with the Financial Times, had mentioned that he was revising his Vioxx injury estimate upwards. (Related article: Merck shows no sympathy for Vioxx victims)

Dr. Graham, an expert at the FDA, and his team analyzed data from 1·4 million people in California who had used NSAIDs from the beginning of 1999 to September 2004. Patients had received various NSAIDs, including celecoxib or Celebrex (around 40,000 users), ibuprofen (just under a million users), naproxen or Aleve (around 43,5000 users), and rofecoxib or Vioxx (around 27,000 users). The investigators found that 8,143 individuals had serious coronary heart disease, 1508 of which had sudden cardiac death. Each case was matched by age and gender to four controls to enable a comparison of coronary heart disease risk among people taking Vioxx and users of other NSAIDs.

People taking Vioxx had a 34% higher chance of coronary heart disease when compared with people who used other NSAIDs. Coronary heart disease was 1·6 times more likely among people currently taking standard-dose Vioxx compared with those currently taking celecoxib (Celebrex) and 3·6 times more likely among high-dose users. The study also found that people taking naproxen (Aleve) had a 14% increased risk of coronary heart disease compared with other NSAIDs. Previous studies have suggested that naproxen protects against coronary heart disease. (Related article: Celebrex, Bextra recall demanded)

Dr Graham comments: “An estimated 88,000-140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib (Vioxx). The US national estimate of the case-fatality rate (fatal acute myocardial infarction plus sudden cardiac death) was 44%, which suggests that many of the excess cases attributable to rofecoxib use were fatal. In the future, when trials show that a new treatment confers a greater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use.” (Related article: FDA should have never approved Vioxx)

In an accompanying commentary Simon RJ Maxwell and David J Webb (University of Edinburgh, UK) write that after the withdrawal of Vioxx increased attention will now focus on the cardiovascular safety of other COX-2 inhibitors (coxibs) like Celebrex, Bextra, Prexige, Arcoxia. Professor Webb concludes: “It now falls to the manufacturers, under the careful review of the regulatory authorities, to provide the evidence that this class of drugs is safe, if necessary including studies that directly address cardiovascular morbidity as a primary outcome. Indeed, the experience with coxibs underlines the need for full publication of all clinical trial data generated in support of newly licensed drugs.” (Related article: Safety of Celebrex, Bextra questioned)

As reported earlier, researchers have also concluded that Vioxx was often over-subscribed due to its aggressive marketing by Merck despite the fact that the drug offered no benefits to vast majority of patients and actually much worse side effects.

So far Merck has not taken any responsibility for deaths and injuries and continues to vigorously attack Vioxx victims. The company also does not accept that Vioxx was a killer drug. In fact, Merck forced one of its researchers to remove her name from a study (that was approved/funded by Merck) linking Vioxx to heart attacks and then criticized the findings, two of the scientist's colleagues say. It is no secret that Merck hid data about Vioxx and often attacked scientists and researchers if they came up with any form of evidence that Vioxx was killing people. Merck recalled Vioxx on September 30, 2004. In one case, it even threatened Gurkipal Singh, an adjunct professor of medicine at Stanford University when he started to study the side effects of Vioxx. Merck also hired paid consultants whose job was to write articles in medical journals and speak at conferences defending Vioxx without disclosing that they were being paid by Merck to do so. "Even after funding and agreeing with the design of the study, Merck publicly discredited our findings," Drs. Daniel Solomon and Jerry Avorn of Boston's Brigham and Women's Hospital wrote in this week's Archives of Internal Medicine in an editorial entitled "Coxibs, Science, and the Public Trust". (Related article: Why Merck did not recall Vioxx earlier?)

Naturally, Vioxx victims are incensed and have been filing class action lawsuits against Merck. In a related development, President Bush and Republicans are getting ready to take away the rights of American people to sue drugmakers when they make lethal drugs like Vioxx. While chances are small that the bill will be passed but it seems that there is a small possibility that American Vioxx victims may be denied justice because the pharmaceutical industry is in bed with the Bush administration.

Recommended article: Complete history of Vioxx and its recall by Merck