The risk/benefit model is broken here: Some risk and no benefit. I'm not going to even address the cost - the benchmark for benefit is incredibly low. All BioGe

The risk/benefit model is broken here: Some risk and no benefit. I'm not going to even address the cost - the benchmark for benefit is incredibly low. All BioGen needed to show was that their drug delayed progression of cognitive impairment for a few months, and they couldn't do it. The FDA acknowledged as such in their conditional approval, weakly suggesting expanded access might allow BioGen to demonstrate this in a larger population. This would lead Medicare to pay for an extensive, unethical study fueled by nothing more than the hopes of desperate patients and their caregivers.