The unfortunate nature of the seen and the unseen is that we will always notice the times we approved a drug too early or tested too aggressively, but we will never notice the deaths that happen because we were too timid or cautious in our approach.

While this case should be studied to ascertain whether process changes could prevent it, the solution is absolutely not further testing, control, and regulation. Hundreds of thousands of people already die or suffer every year because of the paternalistic, conservative policies governing medicine.