Case 6 “Surrogate Markers”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

enkaidNow let’s take a look at the sixth case, surrogate cardiovascular markers. The brand examples I share here are Advicor, which was a combination statin and niacin for the reduction of cholesterol and other related lipid components. In addition, Enkaid was a class 1-C antiarrhythmic.

Now, in the case of both Advicor and Enkaid, we were able to promote that they reduced surrogate markers of cardiovascular disease, but not necessarily reducing the end results of those diseases.

Let me explain. Advicor could be shown to reduce total cholesterol, reduce triglycerides, and reduce LDL cholesterol, as well as increasing the HDL. Now this multidimensional lipid profile was very appealing to prescribing physicians. However, the competitive products had gone a step further to show that their products actually reduced the incidence of heart attacks and heart damage. Because Advicor didn’t do the next level of studies, they were at a competitive disadvantage because while the doctors might think that reducing markers would reduce events, that Advicor could not promote that.

Now the situation in Enkaid was even worse. Enkaid was shown to be a very effective product in improving the heart rhythm. This idea that the heart would overcome its irregular heartbeats made Enkaid a very promising product. However, in the end, when a long term, multi-center, and large patient population study was done to see if Enkaid actually produced an improvement, a reduction in death due to arrhythmias, the product did not perform as promised and was ultimately removed from the market because of that. It’s very important to look at these surrogate end points with somewhat of a critical eye to make sure that one is not over-promising in its promotion.


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