Oct. 2, 1997 ANN ARBOR---The billowing smoke from the national tobacco wars is obscuring an ironic, new economic development---the emerging, multi-billion dollar market for long-term nicotine maintenance.
Tobacco companies are likely to find themselves competing with pharmaceutical companies to develop new products that will deliver nicotine to nicotine-dependent consumers on a long-term basis without smoking cigarettes, according to Kenneth E. Warner, professor of health management and policy at the University of Michigan.
"At present, these two industries have diametrically opposed objectives---the tobacco industry striving to sustain nicotine addictions and the pharmaceutical industry striving to end them," Warner said. But both industries are competing for the same consumer, and as the new market shapes up, it is becoming clear that "current regulatory policy favors the tobacco companies, which encounter little regulation to speak of and can introduce new, nicotine maintenance products quickly and easily."
In contrast, safer pharmaceutical products, such as the nicotine patch or inhaler, must go through long, expensive trials to be approved by the Food and Drug Administration (FDA). The upshot is that they take longer to come to market than tobacco industry products and cost more when they arrive.
Writing in the Oct. 1 issue of the Journal of the American Medical Association, Warner and his co-authors argue that policy-makers must be open to the concept of encouraging the pharmaceutical companies to develop nicotine delivery systems that will be sufficiently attractive to current smokers to serve as long-term, possibly permanent, substitutes for cigarettes. "For smokers who cannot or will not end their nicotine dependence, new, nicotine-only products could greatly reduce their risk of disease," Warner explained.
"The primary goal of a new nicotine policy should remain helping everyone who wishes to be free from nicotine and tobacco to avoid addiction or achieve abstinence. However, some health professionals, concerned that some smokers cannot free themselves from addiction to nicotine, are cautiously considering a harm-reduction strategy that envisions a role for long-term nicotine maintenance using products that deliver nicotine without the other toxic substances in tobacco products."
A policy that makes "minimally harmful" nicotine products available to adults, in a "deglamorizing" social and policy environment "seems worthy of open-minded consideration," Warner said.
"For many health professionals, contemplating competition between the tobacco and pharmaceutical industries for long-term nicotine users will generate a sense of moral repugnance. Like it or not, however, this competition will continue to develop, barring extraordinary measures."
Nicotine replacement therapy products, which aim to reduce or eliminate reliance on nicotine over time, include the familiar nicotine gum and the nicotine patch, and the new nicotine spray and nicotine inhaler, both recently approved by the FDA. Meanwhile, the tobacco industry has developed a cigarette-like device called Eclipse that does not burn tobacco and delivers nicotine in an aerosol consisting largely of water, glycerin, nicotine and carbon monoxide. Unlike the pharmaceutical company nicotine replacement products, however, Eclipse seems to be dedicated to the perpetuation of nicotine dependence.
Historically, the tobacco companies' so-called new and "safer" products, such as "low tar and nicotine" and filtered cigarettes, have done little to protect the consumer because they simply encourage smokers to smoke more often or inhale more deeply to satisfy their cravings for nicotine, Warner noted.
"The introduction of Eclipse thus follows a decades-old tradition, with the industry's apparent intent being to reduce public concern and thereby maintain or expand sales." Many smokers who would have quit if they had had no alternative are likely to continue, "increasing their exposure to nicotine and carbon monoxide, which, on balance, may increase the aggregate disease toll, since quitting is obviously far better for health than continuing to inhale carbon monoxide and nicotine."
Warner and his colleagues suggest that policy-makers consider some or all of the following regulatory measures in order to level the playing field:
--Allow all nicotine delivery devices currently available to continue in the marketplace, but make the least toxic products the most easily available and attractive. For instance, improve the flavor of nicotine gum, and make the new spray or inhaler, which offer rapid delivery of nicotine to the brain, more accessible to consumers.
--Require reduction of nicotine content in cigarettes and chewing tobacco over several years to levels unlikely to cause or sustain addiction. "This would afford current users ample opportunity to wean themselves from tobacco products while reducing the ability of tobacco products to addict future generations of children," Warner explained.
--Require that all nicotine delivery devices, regardless of industry of origin, be evaluated as drug-delivery devices by the FDA and allow advertising only for products that the FDA finds minimally dangerous. If permitted at all, limit cigarette advertisements to black-and-white letter factual text and require that cigarette packages carry warning labels that cover a third of the package.
Warner's co-authors are Dr. John Slade of the University of Medicine and Dentistry of New Jersey, and St. Peter's Medical Center, New Brunswick, N.J., and David T. Sweanor, Non-Smokers' Rights Association, Ottawa, Ont.
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