New Standards

TAKEAWAY: New Standards

In pharma, you have a new molecule, and you have to test for efficacy and side effects. Here, you have a known product that causes disease and premature death that is, if I use the technical term, abusive, per se, because it is addictive. And you have to go to a product that is vastly better.

So what is vastly better? 50 percent reduction in toxicity—60, 80, 90 percent? Nobody had ever defined that and how you do this assessment. So what we decided is to use as a gold standard—cessation. It is not only us. The Institute of Medicine and many others have defined that the closer you are to the effects observed when people stop completely smoking—because we have epidemiology and clinical observations on this—that’s where, the closer you are, you are more confident you can be that you are on the right path.

And we set up a completely new life sciences organization to do this, with everybody coming from pharma. We used the classic aerosol analytics, in vitro, in vivo human clinical trials when we had the confidence that all the rest was OK. And at the same time, we used systems biology—mechanistic understanding on DNA impacts, proteomics, and all these things that are pretty advanced sciences in order to also see whether we find what we find in the clinic at the molecular level.

So that was the first setup. And believe me, that was much more difficult to do—and obviously more expensive for the people that are from this industry that develop the products themselves. And we knew very well, because of the past, that our credibility starts at zero, so the science should be as bulletproof as possible, because there is a lot of controversy about tobacco science from the past. As I have said many times, I can’t change the past. But this time, we don’t have a second chance, so we have to get it right.