As many of you, I got caught up in the whirlwind of a possible new drug entry for Alzheimer disease. A very underserved area juxtaposed by an aging population and backed by a solid biotech company caught my attention. I will start by saying that Biogen is not a client of mine and the stock purchase was for my own private use.
As trial results began to emerge, I was taken aback by one very important element in the trial. The innovators had developed their own composite measure as a testing instrument for their own drug. Basically, the efficacy of the drug was being measured using metrics they had internally developed. They claimed their instrument by design had increased sensitivity when compared to the ones used by clinicians such as the Mini-mental State Exam (MMSE) and ADAS-Cog (Alzheimer’s Disease Assessment scale-cognitive subscale).
I agree that some metrics need to be updated and reflective of today’s widespread practices. However, the problem as I saw it, was their instrument had not been tested and quantified at large. Hence, their double-digit efficacy was based on their model and not a model that had a widespread adoption among clinicians. A bit like the fox guarding the hen house.