July 12, 2009 - Some of the newer smokeless products may not be the kind of reduced-harm product that is the industry's latest hope, now that tobacco is regulated by the U.S. Food and Drug Administration. Winning FDA designation as a "potential reduced-exposure product" could be worth billions of dollars, and a key element of that could be whether an item keeps smokers from lighting up.
The tobacco and drug industries' hottest contenders -- snus, a traditional Swedish oral tobacco, as well as powdered tobacco tablets and nicotine lozenges -- don't ease smokers' cravings for nicotine as well as cigarettes do, according the federally funded study by Virginia Commonwealth University (VCU) researchers Caroline O. Cobb, Michael F. Weaver and Thomas Eissenberg.
Their report in the medical journal Tobacco Control is the first published study of how the smokeless products -- into which the tobacco industry is investing billions of dollars -- deliver nicotine and ease symptoms of nicotine withdrawal. Because the products are so new in the U.S., the researchers have not had enough time to look at whether they helped people quit or caused cancer or other disease.
RESEARCH PAPER: Evaluating the Acute Effects of Oral, Non-combustible Potential Reduced Exposure Products Marketed to Smokers, Caroline O Cobb, Michael F Weaver and Thomas Eissenberg, Tob Control. Published Online First: 2 April 2009. doi:10.1136/tc.2008.028993, ABSTRACT...
"If you switch to these thinking you're going to use them to replace cigarettes and they don't deliver you the nicotine you've been getting and the withdrawal still makes you feel bad, what are you going to do? You're going to go and grab a cigarette," Eissenberg said. And that means they will not be effective in reducing harm to smokers, he said.
Dr. Lars E. Rutqvist, the Vice President for Scientific Affairs at Swedish Match has also stated the drive in Snus sales in Sweden has been in response to the smoking ban rather than the perceived advantage to user’s health.
That snus delivers less nicotine is no surprise to Swedish Match, the Stockholm-based tobacco giant that bases its U.S. operations in Chesterfield County. Swedish Match supports federal regulation of tobacco, hoping that snus will be recognized as a reduced-harm product. "If you are a smoker, there is nothing that compares with a cigarette. . . . It has been designed to be the best nicotine delivery device," said Lars-Erik Rutqvist, vice president of scientific affairs. "Snus is not as good delivering nicotine, but it is good enough to have helped hundreds of thousands of people quit smoking," he said.
The VCU study found snus delivers less nicotine than cigarettes -- about one-third to one-seventh as much. Powdered tobacco tablets marketed by Petersburg-based Star Tobacco deliver about one-sixth the nicotine that a cigarette does, while one of the largest-selling nicotine lozenges delivers a bit less than one-fourth the nicotine.
The smokers studied reported sharp drops in their craving for another cigarette after smoking. Their craving after smoking was roughly half the intensity of what they felt after using snus, tablets or lozenges, as measured by the researchers' numerical scoring system. When researchers asked whether the various products were pleasant, the smokeless items' scores were roughly half those of cigarettes.
Rutqvist said Sweden's experience is that snus can help smokers quit. Only about 11 percent of Swedish men smoke, while 19 percent use snus, according to Swedish National Institute of Public Health statistics. That compares with smoking rates ranging between 25 to 30 percent in most of the European Union and the United States.
"Without snus, based on European prevalence numbers, we'd have another 1.5 million smokers," Rutqvist said, in a telephone interview from his Stockholm office.
Some American tobacco-control advocates say Sweden's experience isn't comparable because there is a long tradition of snus use in Sweden, dating back more than a century, as opposed to the limited introduction of snus here in the past few years. An entire generation of Swedes came to prefer snus during World War II, when cigarettes were hard to get, which affects the smoking-prevalence rates, they say.
Eissenberg and his colleagues have been studying the effects of what tobacco industry officials and tobacco-control experts alike call PREPs, for Potential Reduced Exposure Products, under a grant from the National Institutes of Health.
Such products will be a focus of the U.S. Food and Drug Administration under its new authority enacted last month to regulate tobacco.
They are already a focus of industry attention -- in addition to Swedish Match's efforts to introduce Americans to snus, Philip Morris USA is test-marketing snus in Dallas, Indianapolis and Arizona. In January, Philip Morris's parent company, Altria Group, bought UST Inc., the nation's biggest snuff-producer, for $10.4 billion. Reynolds America Inc. is also marketing snus.
Altria spokesman Bill Phelps declined to comment on the study. "However, we believe that scientific study of potentially reduced-harm products is an important area of scientific inquiry," he said. "With the recently signed legislation giving the Food and Drug Administration regulatory authority over tobacco products, there is now a regulatory structure to evaluate potential reduced-harm products." "Altria believes innovation in developing reduced-harm products is crucial to the success of the new law," he added.
Comments of Dr. John Spangler, M.D., MPH is one of the world's leading experts in tobacco epidemiology. He founded the first physician-run tobacco-cessation clinic at Wake Forest University, School of Medicine. "Those who argue in favor of smokeless tobacco as a means to quit smoking -- an 'alternative' to cigarettes, if you will -- ignore the fact that there is not a shred of scientific evidence showing, in a randomized, controlled clinical trial setting, that smokeless is effective in helping patients quit smoking. This is the level of evidence that the FDA requires before a drug company can market a drug. We should insist on that level of evidence before we start pushing a product that is already known to be unsafe." (Some facts for smokers to consider before considering smokeless tobacco..)
Reference: Study: New products may not curb smokers’ cravings by David Ress, Richmond Times-Dispatch, 7/12/2009.
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