As a nicotine-gum addict, Mike Metzger used to worry about the warning on its label: “Stop using the nicotine gum at the end of 12 weeks.”
But that was before a prominent smoking-cessation scientist, K. Michael Cummings, told him to keep chewing the gum as long as it helped him stay off cigarettes. So 15 years after quitting smoking, Mr. Metzger, a 63-year old retired New York telephone worker, still chews 16 pieces of nicotine gum a day.
Public health officials are backing away from recommending against the long-term use of nicotine gum, lozenges and patches. The Food and Drug Administration is considering whether to eliminate the 12-week warning and instead recommend nicotine-based quit-smoking aids for extended—perhaps even permanent—use. Anti-tobacco activists and GlaxoSmithKline PLC, the U.S.’s leading marketer of nicotine-replacement therapy, or NRT, are also backing the potential move.
“There really doesn’t appear to be any great harm” with long-term use of NRT, says Mr. Cummings, chair of the department of health behavior in the cancer-prevention division at the Roswell Park Cancer Institute in Buffalo, N.Y.. “You’re better off chewing gum or wearing a patch than smoking.”
By giving former smokers the most addictive chemical in cigarettes—nicotine—NRT is designed to ease the difficulty of quitting. In more than a quarter century on the market, nicotine gum, lozenges and patches have amassed a strong safety record. Even among most long-term NRT users, the hazards of nicotine pale beside the dangers of smoking, which is the number one cause of lung cancer and the most preventable cause of cardiac death.
Nicotine itself is not believed by scientists to raise the risk of developing cancer. It may raise the risk of cardiovascular disease, however. It can elevate heart rate, constrict blood vessels and raise blood pressure. Some people have adverse skin reactions to nicotine patches.
Like other addictive substances, nicotine essentially hijacks the brain’s reward system, conditioning users to associate intake with pleasure. But while other addictive drugs tend either to stimulate or relax users, nicotine can do both, depending on the user’s mood, giving it a particularly tight grip.
Sudden withdrawal from the drug can induce intense cravings, nervousness, irritability, confusion and insomnia, among other symptoms.
Obtaining nicotine from gum, lozenge or patch doesn’t replace entirely the pleasure of smoking any more than popping a tablet of caffeine—the addictive element in coffee—could equal the pleasure of a fresh-brewed cup of cappuccino. But jolts of nicotine can reduce the physical symptoms of withdrawal while quitters battle longings for the taste of tobacco, the sensation of smoke and various rituals that accompany the habit. (Going off NRT can also lead to withdrawal symptoms.)
Studies, typically funded by NRT-manufacturers, have shown that those who use the products are about twice as likely to quit smoking after 12 weeks, compared to those who don’t use NRT. But studies of those who successfully quit outside of NRT clinical trials often show no NRT advantage over the cold-turkey approach.
About one in five American adults smokes—a rate that has remained virtually unchanged since 2004.
NRT makers offer different dosages for heavy and light smokers, and recommend that the frequency of use decline over time, for instance, from a piece of gum every hour or two in the first six weeks of quitting to every four to eight hours in weeks 10 through 12.
Glaxo products—which include Nicorette gum and lozenges and NicoDerm patches—account for more than half of the $835 million market in annual U.S. retail sales of over-the-counter smoking-cessation aids, according to market-research firm Euromonitor International. Pfizer Inc. and Novartis AG also market NRT.
Those skeptical of any move to eliminate warnings on long-term NRT use note that many public-health officials and anti-tobacco agencies have received funding from NRT’s makers. “There’s no money to be made in cold turkey quitting, even though cold turkey is how the vast majority of former smokers kicked the habit,” says John Polito, editor of WhyQuit, a popular blog that endorses cold-turkey cessation from tobacco.
The FDA has faced increasing pressure in recent years to loosen its rules on quit-smoking aids. Some public-health groups have filed petitions with the agency urging changes.
Another impetus is the landmark 2009 law signed by President Barack Obama that, for the first time, empowered the FDA to regulate tobacco products. The law, which is partly aimed at reducing smoking’s toll on the nation’s health, instructs the agency to consider rewriting the warnings on nicotine-replacement products, which range from eight to 12 weeks, depending on the type.
The warnings date back to when nicotine gum first received FDA approval back in 1984. They weren’t based on hard science connecting health hazards to long-term nicotine addiction, but were set to mirror the length of use in clinical trials.
Britain’s Royal College of Physicians, which sets health standards in the U.K., concluded in a 2007 report on nicotine addiction that “medicinal nicotine is a very safe drug” and “there are no grounds to suspect appreciable long-term adverse effects on health.”
Many other countries have less-stringent policies on NRT. Canada, Germany, Japan and the U.K. have approved recommended-use periods of anywhere from six to 12 months.
A few studies have examined the use of NRT beyond the current recommendations. Last year, researchers at the University of Pennsylvania published a study in Annals of Internal Medicine that found that smokers who use a nicotine patch for 24 weeks may be more likely to stay off cigarettes than those treated for eight weeks.
However, the study reported no difference in the quit rates of the two groups when they were checked at the one-year mark, revealing the fact that many people began smoking again. The senior author of the study, funded by federal grants, has served as a consultant for GlaxoSmithKline.
Barbara Gregg says that without nicotine gum she likely would have returned to smoking. Ms. Gregg, a 41-year-old executive assistant in the University of Minnesota’s department of medicine, smoked for 22 years before she quit by going cold-turkey in 2007. She started chewing the gum about six months later, after experiencing nicotine cravings.
In 2009, before the start of her mother’s funeral, she kept her father company as he smoked a cigarette in the parking lot.
“I can guarantee you that if I didn’t have nicotine gum with me, I absolutely would have bummed a cigarette off my dad and picked back up again,” she says.
By David Kesmodel: firstname.lastname@example.org and Kevin Helliker: email@example.com