What TTE is about - primum non-nocere

Reflections on a Conversation

Yesterday, one of us had a long conversation with a fellow substacker. The guy was trying to understand the essence of what we do. 

It sums up more or less like this: 

It’s about healthcare, mainly healthcare interventions, such as pharmaceuticals, devices, biologics, and so on. We try to stick to the best available evidence, connect the dots, and end up with lots of questions—lots of questions and no or few answers. 

Perhaps the best example is the 15 questions on the pharmacokinetics (PK) of Comirnaty we listed on 14 May:

Exploring regulatory data sets of the Comirnaty vaccine - 9e

Other folks before us had asked questions, so they were not original discoveries of gaps in the understanding of what happens when you are vaccinated with the stuff. 

However, we documented how we got to the list, stage by stage, using available regulatory documents. 

Why did we not have the answers? First, it’s not our job to do so; we have bodies called regulators to do so. They are paid to ask questi…