All nicotine is not created equal, as SmithKline Beecham Consumer Health Care can attest.
Its Nicorette gum tasted bad--so bad that people who bought it to kick their cigarette habit tended to stop using it too soon and quickly relapsed into smoking.
SmithKline's request to add mint flavoring was recently approved, but only after a seven-month review by the Food and Drug Administration.
However, when the biggest nicotine marketers, the tobacco companies, want to make their products more appealing--such as by adding cherry to snuff or menthol to cigarettes that anesthetizes the throat--they don't have to ask the FDA or anyone else.
This double standard, which is at the heart of a fierce legal battle over the FDA's authority to regulate tobacco products, drives health authorities up the wall.
To exempt "the dirtiest possible nicotine delivery system," the cigarette, while carefully controlling the safest--nicotine replacement products used to quit smoking--is illogical at best, said Kenneth Warner, a professor of public health at the University of Michigan.
"It's not only an unlevel playing field, but we're doing it exactly bass-ackwards," Warner said.
Under its former commissioner David Kessler, the FDA made two key moves in 1996 to level the playing field. It approved over-the-counter sales of nicotine gum and patches--making them more available than when they were sold by prescription only. And in a move that touched off a legal and political firestorm, the agency asserted its authority to regulate tobacco products--triggering a ferocious challenge that is headed for the U.S. Supreme Court.
Some observers see the turmoil eventually leading to a more wide-open nicotine market, in which chronic nicotine use is more or less accepted and nicotine replacement products are allowed to compete as safer alternatives to smoking.
The idea is anathema to many in the health field, who see it as an invitation to drug abuse. "Acknowledgment of the possibility of a world in which nicotine addiction might be tolerated, and even encouraged, would be a bitter pill to swallow for many health professionals," observed an October 1997 article in the Journal of the American Medical Assn. that Warner coauthored.
Nicotine "is not a hopeless addiction," said Dr. Alan Blum, a Houston physician and founder of the activist group Doctors Ought to Care. Promoting "the 'good' nicotine as opposed to the 'bad' nicotine . . . is, at best, a mixed message."
Yet experts agree that nicotine--without smoking's harmful baggage of carbon monoxide and cancer-causing tars--is simply not very harmful to most people.
Neal Benowitz, chief of clinical pharmacology at the University of California at San Francisco School of Medicine and well-known nicotine expert, said the drug increases the heart rate about 10%--roughly the same amount as mild exercise. People with heart conditions should avoid it, he said, but the risk to others does not appear to be significant.
Nicotine acts as a mild stimulant that helps many people focus and maintain vigilance and to relax when under stress.
"There may really be a large number of people that don't want to quit nicotine," Warner said. "They like what nicotine does for them."
Making the drug available in attractive, non-tobacco forms is worth considering, some experts say, if that's what it takes to curb smoking. Unfortunately, smoking is the most satisfying and addictive way to take the drug--delivering a nicotine hit to the brain within 10 seconds of inhaling.
If nicotine replacement products are to compete with cigarettes, "they're going to have to become more consumer-attractive," Warner said, instead of consumer-unattractive by design.
Peppery-tasting Nicorette was Exhibit A--designed to be bad tasting to discourage abuse. The problem was that many consumers failed to use the gum to reduce cravings for up to 12 weeks as recommended.
The mint flavor should improve compliance with directions, said George Quesnelle, SmithKline's vice president for medical marketing and sales. But there will be no mistaking Nicorette for Juicy Fruit or other leading chewing gums. "It still is medicine," Quesnelle said.
For their part, tobacco companies have been preparing for the day when long-term nicotine users might have a choice between conventional cigarettes and an even wider variety of alternative nicotine delivery systems.
In a 1992 memo entitled "Competitive Analysis," a Philip Morris researcher noted: "Different people smoke cigarettes for different reasons. But the primary reason is to deliver nicotine into their bodies." A range of products could supply the need and "replace or transform the worldwide cigarette business as we know it," the memo said.
Philip Morris and R.J. Reynolds have each developed alternative cigarette products that deliver nicotine with hardly any smoke. Philip Morris' Accord and Reynolds' Eclipse are both in test markets.
But other cigarette makers have seen ventures into alternative nicotine products as a political minefield. Another big cigarette maker, British-American Tobacco, once considered the idea of marketing nicotine replacement products such as patches and gum.
Documents show senior executives of British-American and its U.S. and Canadian subsidiaries--Brown & Williamson Tobacco Corp. and Imperial Tobacco--discussed entering the field in 1992, although they ultimately decided not to.
"Given the large proportion of smokers wanting to quit, any device which helps even a small fraction to achieve this goal has the potential to have a negative impact on our business," said a memo by Pat Dunn, head of research and development for Imperial. Therefore, the industry itself should consider producing "alternative nicotine delivery systems."
But in an April 1992 memo, Brown & Williamson attorney Mick McGraw warned that marketing such products would undercut the industry's position that nicotine is not addictive or a drug.
"If we did anything which suggested we were simply in the nicotine delivery business, we would run a serious risk of facing FDA jurisdiction," McGraw wrote. "B&W or BAT would be admitting that the real reason people smoke is for the nicotine."
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The Top Ten
Top over-the-counter drug brands and their percentage sales increase, from 1996 to 1997:
Brand '97 Sales % Change
; (in millions) ('96-'97)
Tylenol 0; $664 ; -1.3%
Advil $302 & #160; 6.0%
Pepcid AC 60; $196 -10.9%
Nicorette &# 160; $192 58. 7%
NicoDerm CQ 60;$171 205.4%
Tums & #160; $154 &# 160; 3.4%
Robitussin & #160; $147 -0.7% 60;
Zantac 75 60; $136 47.8%
Opti & #160; $129 &# 160; 4.0%
Benadryl 60; $127 0; 2.4%
Source: Kline & Co.
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