We wanted to push the paradigm as far as you can go.

I expected the advisory panel to turn the drug down. When they didn't, I was really surprised. And so I now had a potential public health catastrophe in the waiting,

We've been misled many times by observational studies like this,

Physicians ought to take this into account. These drugs are not very forgiving.

We've desperately needed this. The entire public confidence in terms of what is safe for pain has been eroded.

The idea here is if you know what happens in the highest risk individuals, you will know how to use the drugs in people at lower risk. We will have 10 times the statistical power of any study ever done of these drugs.