You may have heard the news hoopla recently when the FDA withdrew the approval of Avastin for the treatment of breast cancer. The world was floored. The news screamed rationing. The comments following all the news stories spoke of lives saved and how dare we put a cost on human lives.
As often happens, emotions trump science and common sense. Here’s how the story went…
Avastin was initially approved not on survival, but on progression free survival. This means that the drug was initially improved based on the data NOT that it saved lives, but that it lengthened the time before the breast cancer progressed. This is the infamous “surrogate end marker” I’ve described often enough. It does not check the actual outcome we want, but instead checks for some reflection of the actual outcome that someone decided might be a good idea to check for. Unfortunately, using surrogate end markers, in the vast majority of cases (if not all), allows drugs that would not otherwise have been approved to make it past the FDA and make drug companies billions upon billions of dollars. It is not until years later (and more billions) that we look at the actual end point and shrug our shoulders meakly, saying that maybe it didn’t work as well as we thought it was going to.
Back to Avastin. It was approved based on the progression free survival. Only later did the real picture emerge. Actual average survival was not increased. The cost for this “miracle” drug? A whopping $92K.
The critics were quick to look at this as a money thing. “Why can’t we spend $92K on a breast cancer patient–does this mean that we can place a value on a life of $92K??” This argument, unfortunately, only works if it actually lengthened survival. Further we need to look at the increased risk of side effects and lower quality of life scores. Again at a cost of $92K.
Looking at the second round of data several years after Avastin was approved, the FDA voted unanimously to withdraw approval of Avastin. The drug’s manufacturer, Genetech was not happy and have contested the ruling. On what grounds, I’m not exactly sure.
Compare this to higher levels of isoflavanoids from soy in the bloodstream of breast cancer patients, where in one study the patients with the higher levels had DOUBLE the chance of survival. All for less than $92,000….