Presented at FDLI Annual Conference, Washington DC, May 4, 2017, 10:45 to 11:30am 1

Transcription

1 Vice President, Research, Health Policy and Abuse Liability Pinney Associates And Professor, Adjunct, Behavioral Biology Department of Psychiatry and Behavioral Sciences The Johns Hopkins University School of Medicine FDLI Annual Conference 4-5 May2017 Presented at FDLI Annual Conference, Washington DC, May 4, 2017, 10:45 to 11:30am 1

2 Through Pinney Associates, I provide consulting services on the development and regulation of pharmaceutical products and tobacco harm minimization products. This includes abuse potential and abuse-deterrent formulation evaluation for the development of scheduling and abuse-deterrent labeling recommendations for drugs. It also includes consulting on tobacco harm minimization (including nicotine replacement therapy and vapor products) to Niconovum USA, RJ Reynolds Vapor Company, and RAI Services Company, all subsidiaries of Reynolds American Inc. In the past three years, Pinney Associates has consulted to NJOY on electronic cigarettes. I own an interest in intellectual property for a novel nicotine medication. 2

3 K. Michael Cummings: Perspectives from the 2017 Report: Ending Cigarette Use by Adults in a Generation is Possible The views of 120 leaders in tobacco control Priority Actions Irina Stepanov: Potential cigarette performance standards: Is there an evidence base? What are the priorities? Raymond Niaura: The public health promise and peril of noncombustible harm reduction alternatives to cigarettes Sudhanshu Patwardhan: Tobacco industry perspectives on tobacco harm reduction? What regulatory goals seem shared by major traditional industry and small novel noncombustible product developers? 3

4 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities 4

5 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities 5

6 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities 6

7 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities 7

8 Filter ventilation and other important design characteristics such as filter type, paper porosity, and cigarette dimensions have impact on: Cigarette elasticity Levels of biologically available nicotine Product appeal Chemosensory perceptions Risk perceptions Smoking behavior Toxicant exposures Talhout et al. Tobacco Regulatory Science (submitted) 8

9 Nicotine is the main addictive constituent in tobacco and smoke Threshold to establish and maintain addiction is ~ 5 mg/day Limit of mg nicotine content per cigarette (assuming up to 30 cigarettes per day and 40% bioavailability). 9

10 Nicotine is the main addictive constituent in tobacco and smoke Threshold to establish and maintain addiction is ~ 5 mg/day Limit of mg nicotine content per cigarette (assuming up to 30 cigarettes per day and 40% bioavailability). Will it work? Donny et al. N Engl J Med 2015; 373(14):

11 Per cigarette measurements (past experience): IARC Monograph Vol. 83 (2004) Hecht et al. Cancer Epidemiol Biomarkers Prev 2005;14(3):

12 Per cigarette measurements (past experience): IARC Monograph Vol. 83 (2004) Hecht et al. Cancer Epidemiol Biomarkers Prev 2005;14(3):

13 Will this reduce exposures? 13

14 Will this reduce exposures? 14

15 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities 15

16 Nicotine dependence Continuous exposure to harmful chemicals Cancer, respiratory and cardiovascular diseases, reproductive and developmental abnormalities Cigarette elasticity 16