Actually his suggestion of a historical comparator is far more significant, for that is exactly what we did - we said that our comparison group was those patients (in the real world) not on the MP. That is a 'historical comparator', and is one of the most ethical, yet controversial, ways of conducting studies in serious diseases.
If I remember correctly (should check back maybe), I think it was mentioned and then dismissed as another issue. But cost of study types -- as well as more than one type of study -- per indication seems to have some sway on what might be put forth as reliable data so discussions like this one on the BBC are significant to note.
I'm just glad that observational studies (and other types) are identified in the FDA critical path and that the UK is also identifying observational studies as important.
The Autoimmunity Research Foundation's work with regards to observational studies and the Web must certainly be a significant cornerstone example of ethical process, as well as reliable. Even if scientists aren't up on the impact of what the ARF has done with the Pathogenesis and Protocol, the Process and Platform have great historical significance.