Last month I wrote a blog post about how the information about the adverse effects of drugs can be neglected, restricted, distorted and silenced. Why is this important? Well, it can harm and kill people, for a start. Some of you may remember that in 2004 the drug company Merck pulled its painkiller Vioxx (rofecoxib) from the market after research revealed it more than doubled risk of heart attack. Subsequently, there were accusations that Merck knew about the problems way before it pulled its money-spinner. This story has resurfaced now, on the publication of a study in the Archives of Internal Medicine .
In this study, research (some published, some not) was analysed, to see at what point there was a clear indication that Vioxx was increasing the risk of ‘cardiovascular thrombolic (CVT) events such as heart attack and stroke, as well as death. It turns out that in by 2001, there was clear evidence of harm. This was more than three years before Merck ‘voluntarily withdrew’ Vioxx from the market. In the intervening time, literally thousands of people died and had heart attacks as a result of this drug.
I saw a report of this study on Reuters Health in which one of the study authors, Dr Harlan Krumholz, makes the point that Most of the information we are using in this study was never published, or if it was published, they never included the key safety data. This sounds likes information on critically important adverse effects might have been neglected, restricted, distorted and silenced to me.
Of course Merck denies any wrongdoing, and is sticking with its story that the first time it was aware of any problems was in 2004. I suppose we need to take this stance in context. It has emerged, for instance, that some studies and review articles supportive of Vioxx were ghost-written by employees of Merck. Plus, it has also been revealed that doctors who were not ‘on side’ regarding Vioxx were targeted by Merck for softening-up and if that didn’t work, an attempt was made to discredit them.
Merck happens to manufacture ezetimibe, the cholesterol-reducing drug which I wrote recently about here. Ezetimibe doesn’t appear to do anyone much good, and has also been linked with a statistically significant increased risk of death due to cancer. Never mind, though, because it appears Merck has managed to find some scientists who claim that this association is likely to be due to chance (even though the stats show it’s very unlikely to be due to chance). Let’s hope history isn’t repeating itself.
1. Ross JS, et al. Pooled analysis of rofecoxib placebo-controlled clinical trial data. Archives of Internal Medicine. 2009;169(21):1976-1985