Two weeks ago I wrote about a review of the evidence for the cholesterol-lowering drug ezetimibe [1]. The authors of the review brought, quite rightfully, our attention to the fact that ezetimibe has never been tested on its own and its health impact compared to placebo. They also admitted, that when ezetimibe is combined with a statin (usually simvastatin), the evidence shows that the outcomes are no better than when the statin is taken alone.
In short, there is no evidence that ezetimibe benefits health.
Despite this, the authors of the review recommend that doctors use ezetimibe to lower raised cholesterol, though two out of the three authors have taken money from the drug’s manufacturer (Merck) for ‘consulting’ and lecturing. You can read the relevant blog post here.
To date, it appears that the use of ezetimibe has been a colossal waste of money. The drug was licensed on the basis of its ability to lower cholesterol. But in 2008 saw the publication of a trial, known as the ‘ENHANCE’ trial, in which the effect of ezetimibe in combination with the statin simvastatin was compared with simvastatin alone. The researchers tracked the thickness of the main artery supply blood to the brain (technically known as ‘carotid artery intima media thickness’) in the study participants. The effect of the drug duo was no better than that of simvastatin alone.
This was not a good result for the makers of ezetimibe, but further controversy swirled around this study because it took two years after the completion of the study for its sponsors (Merck and Schering-Plough Pharmaceuticals) to cough up its results. In fact, it took a US congressional hearing to seemingly force the results out of the manufacturers.
This fact probably contributed to the fact that when the results of ENHANCE were (finally) announced, Merck and Schering-Plough share prices fell, which apparently lost a lot of people a significant amount of money. To recoup this, a class-action was taken against the drug companies, with the plaintiffs looking for financial compensation for losses connected with the drug companies delaying the release of ENHANCE’s negative findings.
The case was due to be tried by jury, but less than three weeks before the trial was due to start a deal was struck. Under the agreement, Schering-Plough (which became part of Merck in 2009), will pay $473 million, and Merck will pay $215 million. Apparently, some of the cost of this settlement will be met by insurance, leaving a bill of $493 million, which it will charge against profits. You can read about more about the story in online in USA Today here.
While it’s probably a good thing that shareholders are compensated, the real victory here is that a light has yet again been shone on a drug company’s shady practices. As part of the settlement, Merck actually admits no wrongdoing, but I should imagine many people will take a different view.
I don’t imagine the half a billion dollars or so Merck must pay will hurt it too much. They can perhaps take it from the money they have made through people taking ezetimibe in the, to date, misguided belief that it is doing them some good.
References:
1. Binh An P Phan, et al. Ezetimibe therapy: mechanism of action and clinical update. Vasc Health Risk Manag. 2012; 8: 415–427
