A University of South Carolina researcher is preparing to answer two questions with widespread implications for the tobacco industry and public-health community.
Can a smokeless product, in this instance Camel Snus, contribute to a smoker quitting cigarettes — particularly one who doesn’t want to stop?
If it does, could an increase in use of smokeless-tobacco products over cigarettes cause a net harm to the population?
Trying to provide clarity is Matthew Carpenter, an associate professor in the Department of Psychiatry and Behavioral Sciences and the Department of Medicine at the Medical University of South Carolina. Carpenter’s research focus has been on tobacco use and control, with his studies primarily funded by the National Institutes of Health.
The yearlong study will consist of 1,250 smokers nationwide, half being given Camel Snus or another smokeless product, and the other half given nothing.
Carpenter’s research team wants to learn whether Snus leads to quit attempts, smoking reduction and cessation. They also want to measure the amount and pattern of Snus use.
“The study will provide strong, clear and objective evidence to guide clinical and regulatory decision-making for this controversial area of tobacco control,” Carpenter said.
Matt Myers, president of the Campaign for Tobacco-Free Kids, said research of smokeless products must evaluate what harm is caused by the product along with how the product is marketed.
“If a smokeless product reduces the risk of disease, but results in more people using tobacco, it could result in more deaths, not fewer,” Myers said.
Carpenter said researchers are not trying to encourage the use of smokeless tobacco with the study.
“We’re just trying to mimic the real-world scenario of a smoker being exposed to these products in their own environment, such as a grocery store,” Carpenter said.
“If they decide to use them, what is the effect? We believe no matter the determination of this study, it will have a public-health impact.”
The study follows up on a similar smoking-cessation study Carpenter released in February 2010 on Star Scientific Inc.’s Ariva and Stonewell tobacco lozenges.
The main determination of that study was smoking decreased by 40 percent during the two-week study period, but overall use of tobacco remained stable.
“This suggests that Ariva and Stonewall are effective products to curb withdrawal and craving,” Carpenter said in his report. “We found no changes in overall craving or withdrawal, as smokers substituted Ariva/Stonewall for cigarettes.
“We found no evidence that smokeless tobacco (Ariva or Stonewall) undermines quitting. To the contrary, readiness to quit — in the next month and within the next six months — significantly increased among smokers who used a smokeless-tobacco product relative to those who continued to smoke conventional cigarettes.”
Carpenter said it is “doubtful that a smokeless-tobacco product could ever serve as a total substitute for cigarettes among a majority of smokers.”
“However, the amount of substitution among those smokers who choose to use smokeless products is not insignificant,” he said.
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The multimillion-dollar Camel Snus study is part of an initiative the National Cancer Institute began in October 2009.
The institute wants to determine whether smokeless products, such as snus and dissolvable Camel Orbs, Camel Sticks and Camel Strips from R.J. Reynolds Tobacco Co., provide “a truly less-harmful alternative to conventional tobacco products, both at the individual and population level.”
“We want to explore all aspects of tobacco products, including the sale, marketing and health risks,” said Michele Bloch, medical officer of the Tobacco Control Research Branch of the National Cancer Institute.
Carpenter said “a number of short-term lab studies of toxicant exposure suggest smokeless tobacco could offer reduced harm as compared to conventional cigarettes.”
Major U.S. tobacco manufacturers, led by Reynolds, are putting more emphasis on smokeless products to gain market share and sales as the smoking rate among adults is declining. Government figures show that fewer than 44 million Americans smoke, down from a peak of 53.5 million in 1983.
“We certainly support studies conducted objectively while using sound scientific principles and techniques on the use of tobacco products and tobacco-harm reduction,” said David Howard, a spokesman for Reynolds.
The evolution of some health-advocacy groups from anti-smoking to anti-tobacco is ratcheting up the moralistic aspect of buying and consuming a legal product.
Some advocates say that smokeless tobacco can serve as a gateway for youths to smoking.
Others are encouraging the Food and Drug Administration to allow the advertising of smokeless tobacco as less harmful than cigarettes if such claims can be proved through research.
A study of smokers ages 18 to 70 — released in November by the Tobacco Use Research Center of the University of Minnesota — found that “quit rates for Camel Snus were comparable to those obtained with nicotine-replacement therapy.”
The Minnesota center said a “properly powered study is needed to determine if use of smokeless-tobacco products with higher nicotine content can be an effective path to smoking cessation, perhaps especially among smokers who are not interested in or previously were not successful with using approved pharmacotherapies.”
Reynolds added fuel to the debate in December when it launched its first campaign aimed specifically at encouraging smokers to switch to Camel Snus.
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Reynolds has marketed Camel Snus as an option for tobacco consumers who can’t smoke in a growing majority of public venues.
Carpenter acknowledges the intensity of debate in his abstract. “There is limited evidence to determine if potentially reduced exposure products ultimately undermine or promote public health,” he said.
John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said he supports research that determines whether smokeless tobacco can help with quitting cigarettes.
Spangler is conducting a National Cancer Institute study, which began in September 2009, that’s aimed at developing strategies to encourage reduced use or even quitting smokeless-tobacco products. Wake Forest received a $2.9 million grant for its study.
Among the goals are: determining the health risk of smokeless-tobacco products; whether the products serve as a gateway for nontobacco users, particularly teenagers and young adults, into smoking; and whether they can be accurately marketed as a reduced-risk alternative to cigarettes.
“We have a substantial amount of data in our research showing that users of smokeless tobacco have a very high likelihood, not of quitting smoking, but of co-using smokeless and cigarettes,” Spangler said.
Bill Godshall, executive director of SmokeFree Pennsylvania, said, “I’d be shocked if Reynolds would apply to market it as a smoking-cessation drug device.”
Scott Ballin, past chairman of the Coalition on Smoking or Health, said the study could demonstrate that there is not enough evidence available about reduced risk, “therefore products like snus or Ariva or Stonewall should not be able to make any claims.”
“That would preserve the status quo and give the pharmaceutical companies the competitive protections they want,” Ballin said.
In October, the consumer health care division of GlaxoSmithKline (GSK), which sells nicotine-replacement therapy products Nicorette and NicoDerm, requested that the FDA take Reynolds’ dissolvable tobacco products out of test markets.
The FDA acknowledges Reynolds is marketing the products to adult consumers, but has concerns that the marketing and shape of the dissolvable products might appeal to children and adolescents.
GSK’s request strikes at the core of Reynolds’ attempt to create a reputation as an innovator of products that could be less harmful to consumers than cigarettes.
Elizabeth Whelan, president of the American Council on Science and Health, said “GSK is clearly trying to protect its own market for dissolvable tobacco.”
“From a business perspective, this is understandable,” Whelan said. “But from a purely public-health point of view, if products like the orbs can help more smokers quit more effectively than other cessation products, then let them stay on the market.”