1. 1 Cytisine for smoking cessation Robert West John Stapleton Magda Cedzynska Paul Aveyard Witold Zatonski

2. Research question Is Tabex (cytisine), a very low cost medicine that has been available in Central and Eastern Europe, effective in aiding smoking cessation?

3. Rationale Nicotine replacement therapy, varenicline, and bupropion have all been shown to be effective in aiding smoking cessation and are licensed in most countries in the world But they are not affordable by most of the world’s smokers Nortriptyline is effective But the side effective profile and need for adverse event monitoring makes it of limited use There is a need for an effective medicine for use with limited behavioural support Cytisine has already been tested and has a very good safety profile At least one ‘GCP’ trial would be needed for licensing

4. Methods Design –Double-blind singe centre placebo controlled trial: 2 arms: individual randomisation by standard program Sample –740 smokers wanting help with stopping smoking not contra- indicated for Tabex Intervention and control conditions –Tabex prescribed according to local licence for 4 weeks versus matched placebo Primary outcome measure –52 weeks of sustained abstinence following end of treatment, biochemically verified according to Russell Standard

5. Characteristics of study sample

6. Timing of study procedures

7. CONSORT flow chart

8. Efficacy

9. Safety

10. Conclusions 1.Cytisine, in the form of Tabex, is a safe and effective treatment for tobacco dependence 2.It is potentially more than 10 times more cost effective than licensed medications 3.It should be affordable by any smoker in the world who wants to use it

11. Publication

12. Press coverage

13. Potential impact Low and middle income countries –The potential market in low and middle income countries is approximately 50 million smokers (10%) who would not otherwise have access to treatment –A single course is expected to help 3 million smokers to stop preventing 1.5 million premature deaths High income countries –If it replaced 25% of current prescriptions in the NHS it could save £20 million per year –In US it could save health insurers approximately $80 million in costs of treatment for tobacco dependence treatment

14. Next steps ExTab has been formed to try to get a marketing licence outside of Central and Eastern Europe In some jurisdictions one more trial will be needed while in others the existing data may be sufficient Extab have been seeking funding for the further trial I have written to the SoS for Health pointing out that a £2 million investment in such a trial would recoup £20 million within once year of licensing – no reply to date Main barriers –vested interests –capitalist system –lack of concern for fellow humans –lack of interest on the part of policy makers in saving taxpayer money