Can we make tobacco history in our life time dr. greg connolly
Can We Make Tobacco History in our Life Time? Gregory N. Connolly, D.M.D., M.P.H. Harvard School of Public Health November 29, 2012
DisclosureI recently resigned my position at Harvard School ofPublic Health to become a Senior Scientific Advisor toa global consumer product manufacturer
My decision was based on a growing realization that a free market that maximizes individual free choice with minimal government interference is best able to benefit society and reward those who contribute most.
Just Ask the People What does Government Best? Selling Power Ball Tickets? Regulating the Market Place? Reducing Poverty?
Steve Jobs sold products: Style, High Tech and Utility It’s the Product StupidApple, 1984 Apple, 2012
“Our company’s strategic priority is to develop,assess and commercialize products that canreduce the health risks of smoking on anindividual and population basis. These are NewGrowth Products or “Safer Cigarettes”. Theseproducts have the potential to be the greatestinnovation in the industry.”
Our new growth products efforts are guided by thefollowing key objectives:“Our first objective has been to develop a series ofproducts that provide adult smokers the taste,sensory experience and smoking ritualcharacteristics that are as close as possible to thosecurrently provided by conventional cigarettes.”
Trends in Per Capita Consumption of Various Tobacco Products – United States, 1880-2004 and Linear Projection to 2035 16 Cigarettes Cigars Pipe/Roll your own Chewing Snuff 14 12 10 POUNDS 8 6 4 2 0 1880 1885 1890 1895 1900 1905 1910 1915 1920 1925 1930 1935 1940 1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 2035 YEARSource: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.
“We are very encouraged by the meeting (with theCenter for Tobacco Products with the Food andDrug Administration) and although several detailsstill need to be discussed, we remain comfortablewith our current risk assessment approach.”
Trends in Per Capita Consumption of Various Tobacco Products – United States, 1880-2004 and Extremely Undesirable Projection to 2060 16 Cigarettes Cigars Pipe/Roll your own Chewing Snuff 14 12 10 POUNDS 8 6 4 2 0 1880 1885 1890 1895 1900 1905 1910 1915 1920 1925 1930 1935 1940 1945 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 2005 2010 2015 2020 2025 2030 2035 2040 2045 2050 2055 2060 YEARSource: Giovino GA. Am J Prev Med 2007;33(6S):S318–S326.
“We are opting for one or two Greenfield facilities in Europe”“…we envisage marketing our NGPs under our existing majortrademarks such as Marlboro.”“…we expect the first factory to be ready in 2015 or 2016 final datafrom clinical studies during the beginning of 2016 and a launch inthe first markets between 2016 and 2017.”However we still must respect fundamental choice of individuals todecide and let them choose and move the market to a safer one
Until consumers accept an FDA approved Modified Risk Product like our NGPs we have as an interim Smokeless tobacco to let free choice move the market to a safer one Some scientist who receive “independent” grants from us see a 95% reduction. The Swedish experience shows it can happened We now have Verve!!
Smokeless Tobacco as an Approved FDA Modified Risk Product Data suggests Swedish Match has lower levels of lung cancer among males where use rates are high and smoking rates low Standards exist for lowering toxins in Swedish Snuss far lower than its concentrations in moist snuff Hard core inadvertent adult smokers who cannot quit should be given the choice for reducing harm Continuum of risk exists among tobacco products with cigarettes highest, Moist Snuff middle and Snuss lowest.
Our Response to Infant Poisoning 45“For instance, in 2007 the total number of reported pediatric exposures for cosmetics was 172,541 compared with only 6,724 pediatric exposures for tobacco.” (Source: RJRT Submission on Impact of Dissolvable Tobacco Use on Public Health to TPSAC, Food and Drug Administration, September 2010) G.R. Krautter, & M.H. Abdelhameed, Clinical and Pharmacokinetic (PK) Characteristics of an Orally Ingested Tobacco Pellet (2007)
VERVE: Our “Much” Safer New Nicotine Chewing GumVerve is a nicotine chewing gum we are test marketing in Richmondwith very low levels of toxins thus greatly reducing the risk ofmany smoking related diseasesAlthough the amount and type of nicotine is a trade secret , wehave provided our consumers with very strong warnings: “This product is addictive, can harm your baby if you are pregnantand can increase your risk to heat disease, aggravate diabetes, etc.”Verve has child proof packaging to prevent poisoning !!!!!
WE Designed Verve “Voluntarily” to Make It the Package Safe from Child Poisoning Let Me Show You
You Can be Part of the Solution!You can help us! Together we can eliminate tobacco disease withNGPs and “safer” SMOKELESSStop Fighting over Menthol and Give Freedom to the Black Smokerto DecideProvide funds to support research and attempts not to havecigarettes sold to children or help tobacco users quitOur power is too great not to accept this offer!
Multinationals Profits vs National GDPs 25,000 $19,817 $19,870 20,000 Millions of Dollars 15,000 32 of the lowest income 4 TTTCs 10,000 nations 5,000 $3,890 Total Budget 0 Total GDP Profits WHO BudgetTotal GDP is inclusive of 32 nations: Tuvalu, Montserrat, Nauru, Kiribati, Marshall Islands, Anguilla, Sao Tome and Principe, Palau, Cook Islands,Micronesia (Federated States of), Tonga, Dominica, Comoros, Saint Kitts and Nevis, Samoa, Solomon Islands, United Republic of Tanzania: Zanzibar,Saint Vincent and the Grenadines, Vanuatu, Grenada, Timor-Leste, Guinea-Bissau, Liberia, Micronesia, British Virgin Islands, Seychelles, Gambia, Somalia,Antigua and Barbuda, Djibouti, Saint Lucia, and Turks and Caicos Islands.
For Countries Who Are Not Ready For Safer Cigarettes We are an international Company competing with the Japanese, British and now the CHINESE!!!!! Your best bet is America!!! We need to make a profit for our Shareholders State Pension Funds, Colleges, Health Insurance Companies. All of You will be affected. We sell the superior America Marlboro with more taste and pleasure and their Light!!! They’ll smoke anyways why not ours???
Female Smokers“The number of Indian female smokers eclipsed those ofChina by 2007, growing by 31% between 2006-2011.”The kinds of innovations in place to cater to this growingconsumer base include super slims – longer, thinnercigarettes… often with a charcoal filter for a smoother smoke,and packaged in so-called “purse packs”…sometimes incolors…coordinate with outfits or mood.”Source: Euromonitor June 2012
Filter and Menthol InnovationRole Filter InnovationMuch of the “added value” NPD activity centers around the filter, as it is here thatthe flavour and any reduced chemical load or odour and enhanced product taste aremanifest. Source: Euromonitor June 2012
Our Response to FDA“’Our company is” opposed to regulationsthat are extreme in nature and are notevidenced based. These include plainpackaging, health warnings covering mostof the pack, display bans and bans on theuse of all ingredients.”Remarks from our CEO
Smokeless Tobacco Warning Labels in the US-Must cover 30% of the two principle sides of package-4 rotating warnings
Federal Tax Rates on Tobacco Products (2009) Previous Tax SCHIP 2009 (New Tax) Tax Increase % Increase % of the Tax on a Cigarette PackCigarettes (20) $0.39/pack $1.01/pack $0.62/pack 158% 100%Small Cigars (20) $0.04/pack $1.01/pack $0.97/pack 2653% 100%RYO Tobacco (20) $0.04/pack $0.80/pack $0.76/pack 2159% 79.21%Snuff (1.2 oz.) $0.04/tin $0.11/tin $0.07/tin 158% 10.89%Chewing Tobacco (2.5 oz.) $0.03/pouch $0.08/pouch $0.05/pouch 158% 7.92% Source: United States Department of Treasury, Alcohol and Tobacco Tax and Trade Bureau. http://www.ttb.gov/main_pages/schip-summary.shtml - December 14, 2009 Note: 20 RYO Cigarettes = 14.5g of Tobacco (0.51 oz)
Current Use of Flavored Smokeless by Users of SmokelessTobacco Products - 2010Maryland Public High School Youth 100% 90% 80% 68.9% 70% 61.1% 60% 50% 40% 30% 20% 10% 0% High School Middle SchoolSource: Maryland Department of Health and Mental Hygiene, Youth Tobacco Survey – Fall 2010. Current smokeless tobacco use is any use of any smokeless tobaccoproduct during the 30 days prior to the survey.
32“The Government has proven that the Enterprise [Tobacco Industry] knowingly and intentionally engaged in a scheme to defraud smokers and potential smokers, for purposes of financial gain, by making false and fraudulent statements, representations, and promises.” United States District Court For the District of Columbia. United States of America et al, v. Philip Morris USA Inc., et al. Final Opinion: August 17, 2006. Civil Action No. 99-2496 (GK).
But What Do You Tell the Kids!! Read What the FDA Scientific Advisory Committee has to Say about US We Would Like to Thank our Non Voting Members for their Collegial Scientific Input into Our Menthol Report!!!
A Jeffersonian View of a Citizens Role in Governance AMy typical day at work on tobacco control
31 Over the past few years, the cigarette industry has acquired the smokeless tobacco industry dramatically changing the incentives for product design and use; Combined use? Maintenance of smoking? Initiation?
Smokeless Tobacco is a Very Serious Public Health ProblemSmokeless Tobacco Causes Periodontal disease Oral Mucosal lesions Oral and pancreatic cancer Low birth weight CHD Addiction Extremely high levels of heavy metals may contribute to unknown systemic diseases
34 Industry Intent on Use “RJRT designed Camel dissolvable tobacco products to complement its current product offerings for adult tobacco consumers who may have an interest in using, or switching to, new smokeless tobacco product.(Source: RJRT Submission on Impact of Dissolvable Tobacco Use on Public Health to TPSAC, Food and Drug Administration, September 2010) RJR: Oral tobacco is an expansion of choice PM USA: Oral tobacco is an adjacency product
35 Use of Snus -Sweden- Has not reduced current occasional smoking Among adolescents reporting current use of oral snuff, 71% also smoked (same as US) 20% of male current smokers also used moist snuff Overall rate of cigarettes in Sweden is 25% higher than Canada, US or Australia has fallen by less over the last decadeSwedish Tobacco Control 2006. Progress & Challenges- both are greater than ever. Swedish Network for Tobacco PreventionWHO IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol.89:Smokeless Tobacco and Some Tobacco-specific N-Nitrosamines. 2007. IARC Monographs Vol. 89. ISBN 978 92 832 1289 8
36 Oral Tobacco -Norway- Males 16-24 Prevalence of daily or occasional snuff use 1985: 9% 2004/5: 33% Prevalence of daily smoking 1983: 28% 2001: 32% Increase in snuff not accompanied by less smoking WHO IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Vol.89:Smokeless Tobacco and Some Tobacco-specific N-Nitrosamines. 2007. IARC Monographs Vol. 89. ISBN 978 92 832 1289
37 Percentage of US High School Students, by Sex, Who Reported Current Smokeless Tobacco Use,* 1995-2009 25 Total Male Female 19.7 20 15.8 14.8 15 14.2 13.6 15 13.4 Percent 11.4 11 9.3 8.9 10 7.8 8.2 8 7.9 6.7 5 2.4 1.9 2.2 2.2 2.3 2.2 1.5 1.3 0 1995 1997 1999 2001 2003 2005 2007 2009 YearSource: National Youth Risk Behavior Surveillance Surveys, 1995 – 2009* Used chewing tobacco, snuff, or dip on 1 of the 30 days preceding the survey
Percentages of Cigarette Use among Past Month 38 Smokeless Tobacco Users, by Age Group: 2002 to 2009 –USA- Source: SAMSHA, 2002-2009 NSDUHs
40 Dissolvables Health Effects•Infant Child poisoning•Youth Initiation•CHD (Heavy Metal, Nicotine)•Cancer (TSNAs, Heavy Metals, PAHs)
Using the “Smokeless” Argument to Invent New Nicotine Drug Delivery System (.6 – 3.3 mg/unit)
Lethal Nicotine Poisoning 43 Dosages ToxicologyEstimated lethal pediatric dose of nicotine is 1.0 mg - 1.4 mg / kg bodyweightAverage body weight of an infant one year old is 22.7 pounds, or 10.3 kg.*Lethal dose for an infant one year old, of average body weight, is 10.3 – 14.4mg.Novel Dissolvable Tobacco Product Estimated Lethal DoseCamel Orbs (1 mg nicotine per pellet)* 10 – 15 pelletsCamel Sticks (3.1 mg nicotine per 3 - 5 sticksstick)*Camel Strips (0.6 mg nicotine per 17 – 24 stripsstrip)**conservatively high estimate* Per manufacturer’s promotional literature
FDA Tobacco Product Authority-Standard setting for existing or substantially equivalenttobacco products. Burden is on FDA to make a findingwith likely legal challenge (menthol)-New tobacco products introduced after 2/15/2007 withno substantially equivalent predicate tobacco product;burden on industry to demonstrate-Modified risk tobacco products that make a claim theburden is on industry to show risk reduction
SLT: Population Impact Initiation: Graduation strategy to promote youth addiction and only male adolescents have shown a significant increase in use paritcularly flavored products Maintenance: Industry is actively promoting Snuss as a way to arrest the decline in cigarette sales through dual use There is science to support Swedisn Toxin level reduce risk
US Tobacco’s Dose-Controlled “Graduation Strategy” COPENHAGEN SKOAL SKOAL/KEY WINTERGREEN NATURAL GRADUATION PROCESS GRADUATION PROCESS SKOAL SKOAL SKOAL SKOAL LONG CUT LONG CUT LONG CUT LONG CUT WINTERGREEN MINT MINT NATURAL HAPPY DAYS MINT HAPPY DAYS HAPPY DAYS LONG CUT SWEET NATURAL LONG CUT LONG CUT SKOAL SKOAL SKOAL SKOAL BANDITS BANDITS BANDITS BANDITS WINTERGREEN MINT SWEET NATURALSource: Marsee vs. UST. UST Document No. 12017104. Court Exhibit No. 100.
Dual Users are a Big Driver of Current MST Growth “Based on our research, we believe the bulk of smoker migration into MST is coming from dual users (consumers that dip and smoke). We estimate that about 30% of dippers also smoke. The proliferation of smoking bans has effectively increased the number of dipping occasions. Source: UBS Research, 2007, Nat’l Tobacco Incidence Study [UST]
TSNAs: Snus vs. Moist Snuff (ng/g)1800016000140001200010000 8000 6000 4000 2000 0 Taboka PM Camel Snus Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro Marlboro (Texas) SNUS Rich SNUS Mild SNUS Spice SNUS Mint Fine Cut Long Cut Fine Cut Long Cut Original Original Wintergreen Wintergreen Mg/g
Facebook Does Baking Soda Give You a Buzz? “Baking Soda is basic and it opens up the pores in ur lip and gum allowing for more nicotine if u want a buzz tha’s an easy way.” Does one cut the webbing in their foot so you can still get the satisfaction during school? “All u gotta do is cut urself between your big and second toe, then pack it like u would ur lip, throw a sock on and u have descreet enjoyable dippin.”
The Bottom Line for Health orPublic Health Professionals“To recommend use of a cancer causing, addictive product in lieuof smoking while safe approved cessation medications exist raisesprofessional, ethical and liability questions and may violate theoath to do no harm.”
Snus & NRT Annual Dollar Sales (2003-2007) 2003 2004 2005 2006 2007 FDA- $437,482,997 $444,561,898 $477,086,467 $496,640,220 $501,806,178 Approved NRT Snus $0 $15,239 $14,300 $34,349 $32,773Source: AC Nielsen ScanTrak, including sales in US food stores with at least $2 million in annual sales, US drug stores with at least $1 million in annual sales and all US mass merchandisers, with the exception of WalMart.
FDA Authority•Directive-Controls behavior ofmanufacturing•Gatekeepers-Defines debate, agenda whilekeeping he gate closed•Conceptual-Ability to shape concepts andstandards
FSTCPA Challenge Freezing Innovations? No new products should be allowed into the market unless they reduce public health impact . Exempt are Substantially Equivalent products with a predicate (like) product in market as of 2/15/07. The key to is success is an FDA restrictive not permissive definition of substantially equivalent that can survive a legal challenge
Submissions to the FDA for Substantially Equivalent (SE), 33New and Modified Risk Products (MRTPs)(up to April 2011) (A Clear Definition of Dissolvables is Needed) Application 4/11 SUBSTANTIALLY EQUIVALENT 3,661 NEW 0 Products MRTP Products 16 Source: Food and Drug Administration, June 2011
Substantially Equivalent to What? -Section 905(j)Predicate Product or Predicate Product
The Family Smoking Prevention and Tobacco Control ActThe states gave the federal government authority due tothe lack of state resources of expertise to regulatetobacco productsHighly centralized, non-transparent rule making bodyA body that must maintain strict neutrality as would acourt of law while subject to political realities of anadministrative agencyCAN WE WAIT FOUR MORE YEARS ????
Local Tobacco Control Must Remain as Locus of Tobacco Reduction in America-The environment has changed and we must use our local authoritywisely and courageously and to set moral limits on the tobaccomarket. Demand Federal and FDA accountability and involve ourfederally elected officials to do so!--Stick to our strengths! Level the playing field between cigarettes andSLT: Taxes, Prohibiting public use of all tobacco products, localpublic education, well funded programAvoid issues of federal preemption in the FSTCPA and issues ofrestricting speech
Like SHS We Need a New Effective Local Interventions Licensing of Retail Outlets (Constitutional) Limit the Number of Licenses as with Alcohol Limit Location (schools), Density as Retailers Close, Age of Entry(adults only) and Products Sold Products: No Flavored Products, Require Child Proof Packaging (2015), 18 years after enactment (2030) allow sale of non initiating prodcuts
“A Tiny Ripple of Hope” “Each Time a Man Stands up for and Ideal or acts to improve the lot of others or strike out at injustice, he sends forth a tiny ripple of hope, and crossing each other from a different centers of energy builds a current that can sweep down the mightiest”Robert Kennedy 1986 South Africa
"They can crush a few flowers, but they cannot hold back the springtime."Sister Pat Farrell, Leadership Conference of Women Religious August 2012