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Nicotine Yes, Tobacco No [06/30-1]

Excerpts from FEEDING THE NICOTINE HABIT:
FINDING SAFER SUBSTITUTES FOR CIGARETTES

by Sandra G. Boodman, Washington Post [06/30/98]

For 55 years, Clarence Heidemann couldn't imagine life without cigarettes. Then in 1991 he kicked the habit with the help of nicotine gum, which his doctor told him would help him over the biggest hurdle: the crucial first weeks when the vast majority of would-be quitters relapse.

Seven years after he traded two or three packs of cigarettes each day for a dozen pieces of the gum called Nicorette, the retired paper mill manager finds himself saddled with another habit he'd like to break. "I don't think I'm addicted to it," said Heidemann, who chomps on the bitter, dun-colored gum every day. "But it's certainly become a habit."

Heidemann, it seems, has plenty of company, although there's no way to know for certain how many ex-smokers use nicotine gum or nicotine patches for months -- or years -- longer than the six to 12 weeks approved by the Food and Drug Administration.

Radio talkmeister Don Imus recently admitted to his listeners that he has chewed Nicorette for the past 10 years. Syndicated political columnist E.J. Dionne, a former three-pack-a-day smoker, has confessed a similar addiction. And a large, federally funded study of 6,000 current and former smokers found that 19 percent were still chewing the gum after five years, with no apparent ill effects, even if some continued to smoke.

Heidemann, 75, who lives in Valdosta, Ga., said his doctor is not concerned about his continued reliance on nicotine gum. "He said it's not harmful and it's better than smoking."

The view that nicotine, when it is not smoked, is a relatively benign and possibly beneficial drug is gaining acceptance among scientists as well as physicians, particularly those who run smoking-cessation programs. This dramatic change in attitude has ushered in new and sometimes controversial approaches to treating smokers.

While most users of the gum and the patch manage to wean themselves from nicotine, others seem unable to do so. As a result, many experts now contend that for the most addicted smokers, nicotine maintenance appears to be a more realistic goal than nicotine abstinence.

They point to a growing body of research that shows that prolonged and, especially, heavy use of tobacco appears to change the makeup of the brain, resulting in the proliferation of nicotine receptors. These receptors are responsible for the sense of pleasure and improved concentration that smokers report from having a cigarette.

"Ten years ago the assumption was that anyone hooked on nicotine could get off tobacco and probably nicotine," said Jack Henningfield, a nicotine expert who was formerly chief of clinical pharmacology at the National Institute on Drug Abuse. "But over the last several years there's been a proliferation of data showing how nicotine changes the brain.

"One of the big issues that has driven a lot of people in public health is that for most smokers, nicotine maintenance is not a question of whether, it's a question of how," added Henningfield, now a private consultant in Maryland. Many smokers, Henningfield noted, have switched to so-called "light" cigarettes in an attempt to lower their risk of smoking-related illness.

But studies have repeatedly found that these "light" cigarettes are just as lethal as unfiltered cigarettes, in part because smokers inhale more deeply. "The drive for nicotine maintenance is fueled by the fact that most people are maintaining themselves on the most deadly form of nicotine ever invented," he added.

"Our problem is getting people to use enough of these nicotine replacement treatments early on," said John R. Hughes, an addiction expert who is a professor of psychiatry at the University of Vermont School of Medicine. "I'd rather have 90 people use the patch or the gum for too long than two people use it too short a time and resume smoking."

The other, more contentious approach is known as "exposure reduction" -- persuading smokers to use the gum, nicotine patch or other treatments to reduce their cigarette consumption. This approach is already being employed by smokers in situations where lighting up is prohibited, such as on airplanes. Supporters say the advantages are twofold: Nicotine replacement is safer than smoking and using it might motivate smokers to quit.

"There is something that we can do for people who are unable or unwilling to quit smoking," Henningfield said. "But there are enormous social, political and regulatory barriers, as well as legitimate concerns" to this approach.

Chief among these is whether telling smokers they should cut down will undermine the drive to get them to quit altogether. The other problem is the lack of evidence that cutting down but not quitting results in a lower risk of mortality or illness.

"Exposure reduction is far and away the number one issue," said Mitchell Zeller, an associate commissioner of the FDA who has worked on tobacco regulation. "We know that if you quit, you'll live longer, but we don't know if you'll live longer or reduce your risk of disease if you reduce your consumption of cigarettes from 30 to 20 a day. Even though we believe it in our hearts, we can only go where the science will take us."

Addictive but Not Deadly

Although nicotine is the ingredient that makes cigarettes so addictive, it is not what makes them so deadly.

Unlike cigarette tars that contain dozens of cancer-causing chemicals, nicotine is not a carcinogen, contrary to popular belief. People who use nicotine replacement products -- the gum, patch, nasal spray or inhaler -- also do not ingest carbon monoxide, as do smokers.

"Nicotine dependence is clearly the major physiological driving force behind cigarette smoking, but it's tobacco dependence that kills," added Sachs, a clinical associate professor at Stanford University School of Medicine who estimates he has treated 10,000 smokers in the past two decades.

"Nicotine in replacement products is a much safer substance and generally people take in less nicotine anyway," agreed Neil Benowitz, a professor of medicine and psychiatry at the University of California, San Francisco, and one of the scientific editors of the landmark 1988 Surgeon General's report on nicotine addiction and smoking. Benowitz and other experts cautioned that while nicotine in replacement products seems fairly harmless, it can raise the heart rate, as does smoking. Furthermore, nicotine's effect on fetal development, nursing infants or people with certain heart problems is unknown. Like all drugs, Benowitz noted, nicotine replacement treatments have risks "but I think the risks are probably small."

Relapse Remains the Rule

Between 1984 and 1996 there were only two nicotine replacement treatments available -- the gum and later the patch -- and both required a doctor's prescription. In 1996 the FDA approved over-the-counter sales of both products, hoping this would spur more smokers to use them and quit cigarettes. Studies had shown that many smokers said they wanted to quit but 70 percent said they would not see a doctor for a prescription.

Most people who try to quit still use the old-fashioned and least effective method: They go cold turkey. Nearly half of them relapse within the first 48 hours, according to Vermont's John Hughes, while 66 percent don't last a week before reaching for a smoke.

Those who use the gum or the patch or another form of nicotine replacement increase their chances of quitting from about 5 percent to between 10 and 20 percent, depending on their motivation and other factors. Those who are highly motivated and use nicotine replacement products in conjunction with supportive counseling raise their chances to about 30 percent.

Relapse, Hughes and others say, remains the rule, a testament to the pervasiveness of nicotine and its addictive power. Smokers typically quit five to 10 times before going smoke-free for good.

Every year, according to federal statistics, about 1.2 million Americans stop smoking. The number and prevalence of ex-smokers has risen dramatically in the past 20 years. Currently, about 25 percent of American teenagers and adults smoke, while 25 percent are ex-smokers and 50 percent never smoked. In 1976, according to the 1988 Surgeon General's report, nearly 37 percent of the population smoked.

Not everyone who smokes regularly is addicted to nicotine, experts say. Stanford's Sachs estimates that an estimated 90 percent of the nation's 46 million smokers are addicted and their dependence ranges from mild to severe.

Smokers with mild addictions -- or none at all -- are among the minority of users who can quit with no trouble and don't need to regularly ingest nicotine. They are known as "chippers," a phenomenon seen among a minority of heroin and cocaine users whose drug use is largely confined to social situations. These chippers can quit easily without experiencing the cravings, depression, anxiety or irritability that more addicted users typically report.

There may be a biological reason for this. A study by University of Toronto researchers published last week in the journal Nature has found that some people carry a genetic variant in a liver enzyme that may protect them from nicotine addiction. People with this genetic variant appear to metabolize nicotine more slowly and usually smoke fewer cigarettes than those without it.

Slower Release of Nicotine

Few side effects, none of them serious or permanent, have been reported with the gum or patches, which account for more than 90 percent of the nicotine replacement market. The deliberately bad taste and texture of the gum -- combined with the price and prohibition on sales to anyone under 18 -- have helped discourage abuse by teenagers, FDA officials say.

The chances of abuse were always considered small for basic pharmacological reasons, scientists note, since both products release nicotine far more slowly than do cigarettes.

"It has to do with the dose and the dosage form," said Maxine Stitzer, a psychiatry researcher at Johns Hopkins University School of Medicine who studies nicotine, heroin and cocaine addiction. "Cigarettes deliver an instant hit. Within 10 seconds they deliver nicotine to the brain. The patch releases it gradually; it takes two to four hours to reach peak levels of nicotine. The gum is somewhere in the middle. It takes about 15 to 20 minutes to reach the same level as the patch."

Unlike Ritalin, a stimulant widely prescribed for attention deficit hyperactivity disorder that some teenagers have sold to classmates seeking to get high, nicotine has little potential as a drug of abuse.

Nonsmokers who try the patch or the gum looking for a buzz are more likely to wind up with a pounding headache, dizziness, a queasy stomach and an unpleasant jittery feeling similar to that induced by consuming massive doses of caffeine.

Nicotine is not instantly addicting. Smoking, as every smoker or ex-smoker knows, takes considerable practice. One study estimated that it takes about 100 cigarettes to become hooked on nicotine.

In 1996 the FDA approved two other forms of nicotine treatment that are available only by prescription. They are a potent nasal spray, which delivers nicotine within a few seconds, and an inhaler, which resembles a cigarette. The inhaler allows users to draw nicotine into their mouths, where it is absorbed; most of it never reaches the lungs.

There is a fifth alternative, an antidepressant called Zyban approved last year for smoking cessation treatment. The drug, also known as Wellbutrin SR, contains no nicotine but has been effective in fighting the cravings smokers commonly report.

NICOTINE REPLACEMENTS

Nicotine gum and the nicotine patch, which are available over the counter, account for more than 90 percent of the nicotine replacement market. Both products, however, release nicotine much more slowly than do cigarettes.

"Cigarettes deliver an instant hit," said Maxine Stitzer, a psychiatry researcher at Johns Hopkins University School of Medicine. "Within 10 seconds they deliver nicotine to the brain. The patch releases it gradually; it takes two to four hours to reach peak levels of nicotine. The gum is somewhere in the middle. It takes about 15 to 20 minutes to reach the same level as the patch."

Two other forms of nicotine treatment are available only by prescription. They are a potent nasal spray, which delivers nicotine within a few seconds, and an inhaler, which resembles a cigarette. The inhaler allows users to draw nicotine into their mouths, where it is absorbed; most of it never reaches the lungs.

* Nicotrol Nasal Spray: Each dose consists of 1 spray per nostril and contains 1 mg. Maximum daily recommended use is 40 doses.

* Nicoderm CQ Patch: Delivers 7, 14 or 21 mg. over 24 hrs.

* Nicotrol Patch: Delivers 15 mg. over 16 hrs.

* Habitrol Patch: Delivers 7, 14 or 21 mg. over 24 hrs.

* Prostep Patch: Delivers 11 or 22 mg. over 24 hrs.

* Nicorette Gum: 2 or 4 mg. per piece. Do not exceed 24 pieces per day

* Nicotrol Inhaler: Delivers 4 mg. per cartridge. For best results use 6 to 16 cartridges per day

* Cigarettes: Delivers an average of 1 mg. per cigarette

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