Two major cigarette companies have entered the market with cigarette-like nicotine delivery devices they hope will substantially lessen the health risks of conventional cigarettes. R. J. Reynolds Tobacco Company released the "Eclipse" in several cities in 1996 and 1997, and Philip Morris introduced its "Accord," in what the company calls a "limited retail sales test," in Richmond, Va., in August 1998.
Critical observers of the tobacco industry, such as K. Michael Cummings, Ph.D., senior research scientist at Roswell Park Cancer Institute, Buffalo, N.Y., see these as the first primitive examples of a new genre of nicotine delivery devices.
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Cummings predicts that the line between devices designed to make money from nicotine addiction and those designed to help addicted smokers quit will soon blur. Already, at least one cigarette company has taken steps toward becoming a purveyor of pharmaceuticals.
The question is, what impact will these products have on public health? And will would-be quitters switch to "low-smoke" cigarettes instead of kicking the habit? Will more non-smokers become addicted to nicotine delivery devices? Some former smokers are unable to stop using the nicotine replacement therapies that enabled them to quit. Don Imus, the radio talk show host, has chewed Nicorette for more than a decade, a Washington Post article noted in June of 1998. How dangerous is that?
High Stakes
The stakes are high. Smoking-related cancers take 155,000 American lives annually, and cancers from passive inhalation account for an additional 3,000 deaths annually, according to the Centers for Disease Control and Prevention in Atlanta, Ga. The total number of yearly deaths in the United States from environmental tobacco smoke, due to all medical causes, is 53,000, according to Stanton A. Glantz, Ph.D., a statistician who is professor of medicine at the University of California, San Francisco. And heart disease actually kills more smokers than cancer approximately 180,000 Americans annually, CDCP statistics show.
Initially, RJR's Eclipse appeared to be far cleaner than a conventional cigarette. The roll of tobacco, which is mixed with glycerol and serves as a carrier, is merely heated, not burned. This volatilizes nicotine, so that the smoker gets a fix without inhaling a cloud of carcinogens, such as those that contaminate tobacco smoke. An Eclipse cigarette contains 2 to 3 milligrams of tar, compared to 15 to 20 milligrams in a full-flavored cigarette and at least 6 milligrams in a "light" cigarette. Nicotine itself is not carcinogenic, according to the International Agency for Research on Cancer, but is implicated in heart disease.
While Eclipse and Accord may mitigate the carcinogenic hazards associated with normal cigarettes, these early cigarette-like nicotine delivery products probably do not greatly reduce the danger of heart disease. Inhaling nicotine directly into the lungs results in an "arterial spike," which causes an increase in heart rate and contraction of the arteries, said Jack E. Henningfield, Ph.D., an industry critic who is vice president for research and health policy at Pinney Associates, Bethesda, Md. Carbon monoxide from combustion creates further arterial stress, by displacing oxygen at the oxygen-binding site of the hemoglobin molecule.
Nevertheless, "the chemical makeup of Eclipse is vastly different from the chemical makeup of a conventional cigarette," said Cummings. "It eliminates many of the chemicals that we worry about from cigarette smoke." Eclipse also reduces sidestream and secondhand smoke by about 80%.
Unfortunately, Eclipse creates its own hazards. The mechanism for heating the tobacco is a carbon tip, which the smoker lights like a normal cigarette. A casing of glass fibers insulates the tip from the tobacco. But thousands of microscopic glass fibers contaminate the mouthpiece, and smoking would draw them into the lung, said John L. Pauly, Ph.D., a cancer research scientist in the department of immunology at Roswell Park Cancer Institute, who studied the problem.
"Fibrous glass materials are carcinogenic and should be listed in the ARC [the Annual Report on Carcinogens prepared by the National Toxicology Program]," concluded Peter F. Infante, Dr.P.H., director of the Occupational Safety and Health Administration's Office of Standards Review, and colleagues in a 1994 review article published in the American Journal of Industrial Medicine. (Charles Jameson, Ph.D., of the National Institute of Environmental Health Sciences, said that glass wool, which has been studied extensively in animals, is at this point "reasonably anticipated to be a human carcinogen.")
Cummings said this filter defect could easily be corrected, at which time Eclipse could become a valuable alternative to conventional cigarettes. But in its present form, the product should be pulled from the market, he said.
"Smoking System"
Philip Morris's cigarette alternative is a "smoking system," which the manufacturer claims reduces carbon monoxide by 94%, benzene by 98%, and tobacco-specific nitrosamines by more than 98%. Sidestream smoke is almost entirely eliminated, and secondhand smoke is minimal. An Accord delivers about 3 milligrams of tar.
The nucleus of the smoking system is a device that looks something like a miniature television remote, called a Puff Activated Lighter (TM). The specially manufactured Accord cigarette fits inside the Puff Activated Lighter. Each draw activates, sequentially, one in a series of eight long, narrow blades that run lengthwise along the cigarette, within the lighter's belly, said Mary Carnovale, Philip Morris's manager of media affairs. Each blade delivers a 2-second burst of heat, which singes some of the tobacco.
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While Eclipse, Henningfield said, delivers a "high dose of nicotine and carbon monoxide," reduced nicotine, carbon monoxide, and other toxins from Accord might reduce the likelihood of heart disease compared to conventional cigarettes. But "we don't have the data," he added.
Henningfield also points out that glycerol, which is used by Eclipse as a carrier for nicotine, is converted at high temperatures to acrolein, which "can contribute to chronic obstructive pulmonary disease."
Nonetheless, Cummings sees plenty of opportunity for development of cigarette substitutes that could mitigate the cardiac dangers. He alluded to Targacept, Inc., a wholly-owned subsidiary created by RJR, whose mission includes "to investigate whether novel therapeutic compounds could be created to treat [Alzheimer's, Parkinson's] and other diseases," according to RJR documents.
This possibility is suggested by the existence of different types of nicotinic receptors. Analogs might also be created that provide nicotine's satisfactions without its artery-contracting, blood-pressure raising effects, said Cummings.
Cummings and some others think that ultimately the public health impact of cleaner nicotine delivery is likely to be positive.
Once such devices are widely marketed, banning conventional cigarettes becomes practical, he said. In sufficiently low doses, as in smoking cessation devices such as gum and the patch, nicotine itself is innocuous, said Cummings. The dose is too small and delivered too gradually to create a risk of either heart disease or a de novo risk of addiction. A study by John J. Mah-marian, M.D., professor of medicine at Baylor College of Medicine, Houston, has shown that the patch is safe even in patients with coronary artery disease.
But Henningfield, for one, worries that "If you have companies marketing something to create and sustain nicotine addiction in people who don't need nicotine, there is a risk with no benefit."
And even Cummings fears cleaner nicotine delivery will enable cigarette companies to circumvent workplace bans. These, he said, encourage people to quit because they find they can do without cigarettes. He has published data indicating that a universal workplace ban would result in 178,000 additional quitters. This represents a small percentage of U.S. smokers, whose numbers are roughly estimated to be greater than 50 million.
Regulatory Fears
Nonetheless, RJR and Philip Morris are doing little to promote Eclipse and Accord. The reason, Cummings said, is that in order to make health claims, they would need to have their products tested by the U.S. Food and Drug Administration. That would open the door to regulation. Furthermore, "The introduction of a safe cigarette will mean the downfall of all other cigarettes on the market," said Cummings.
Summing up the debate, Dietrich Hoffmann, Ph.D, associate director, American Health Foundation, Valhalla, N.Y., said, "For those who cannot or will not give up smoking, toxicity and carcinogenic potential must be reduced as far as possible." As The New York Times once editorialized, "The best should not be the enemy of the good."
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