When a Cause isn’t a Cause: The Failure of Vytorin
Vytoria is a drug intended to improve heart disease. There are already millions taking it, or one of its parts. Full results of its trial were released Sunday, March 30th. Although Vytorin successfully reduced three key risk factors, it did not improve heart disease, because it had no effect on reducing plaque. The three risk factors improved by Vytorin, and thought to lead to plaque buildup, which leads to heart disease, were LDL (low-density lipoprotein, or bad cholesterol), triglycerides (a form of fat made in the blood), and artery inflammation as measured by CRP (C-reactive protein, which is released into the blood due to inflammation). So, if we look at the root cause analysis, we have:
But if this is our Cause Map, and we reduce all three causes, we should reduce the result - plaque formation, which should reduce the occurrence of heart disease. If we end up with the results we have here, which is no effect on plaque buildup despite proof that the three causes (called “key risk factors” in the medical world) have been reduced, it means there’s a problem with our root cause analysis. This particular analysis gets even more confusing. Some drugs, like statins, lower LDL and successfully reduce heart disease. This implies that the cause-and-effect relationship of LDL and heart disease is valid. But there was a drug that is no longer being advanced that successfully reduced cholesterol, but actually raised heart risks. What does all this mean? It means back to the drawing board on our cause map. I don’t pretend to have the answers - I don’t think anybody does, or there would be a new drug out there right now - but it means that as you’re reading this, the smart folks developing new drugs are donning their lab coats and trying to figure out what went wrong.