9 October 2020
For us, it's also important to be able to share with the regulators what we're doing and what we know

Sharon Carty, Director of Clinical Science & Epidemiology Operations

Below is the transcript of the video:

There is a huge amount of data that's around that is publicly available that shows the effects of or the benefit of quitting smoking on people's health—on smokers' health. But that data was collected over years and years of people smoking and some people quitting. And so, in an ideal world, we would run a study where we would follow people who would switch to a reduced-risk product such as a tobacco heating system. And then we would follow them for ten or more years because that is the length of time it takes to develop those diseases. So to actually see something, we would have to run studies that are that long

So in order to be able to see something sooner and not have to wait ten years, what we can do is look at people who are at an early stage of development of a smoking-related disease and see what happens when they switch and is there an effect on the progression of the disease. Does it slow down as opposed to people who continue to smoke?

We've been doing clinical studies for many years, so we've done a fair amount of clinical studies in healthy volunteers. Short term studies going from one week roughly up to twelve months where people were switching to the product over that expanse of time. All of this, the bulk of this was done before the product was on the market, the tobacco heating system, and this data we've shared with the FDA. For us, it's also important to be able to share with the regulators what we're doing and what we know.

Now what we're moving into is: the product is on the market in a number of countries so now we can actually start to look at the longer-term effects of switching to these products.

So, we are beginning. We're in the early days of designing programs and studies to look at the longer-term effects.