HEALTH : Smoky Issues in Debate Over Nicotine Products

Should nicotine substitute products designed to help smokers quit cigarettes be available without a prescription?

It is an issue that almost has been overshadowed by the recent national debate over whether the federal government should regulate tobacco. Nevertheless, at least one manufacturer has asked the U.S. Food and Drug Administration to consider changing the status of these products, which include gum and skin patches, to make them available over the counter.

Proponents of the change argue that making these products more accessible would remove a major obstacle most smokers face in seeking help quitting the habit--having to see a doctor to get a prescription. Granting over-the-counter status will help more people stop smoking, they say.

But other experts raise the very different and disturbing possibility that the easy availability of such items would only create new nicotine addicts.

“The classic argument (in favor of over-the-counter status) has been: To purchase nicotine in a form that will kill you, you can buy it from a vending machine in a shopping mall,” said one anti-smoking lawyer knowledgeable in tobacco regulation. “To purchase it in a form that will help you quit smoking, you have to go to your doctor.

“It’s a hard question,” added the lawyer, who requested anonymity. “Making people go to a doctor is a barrier, and costs money. But what about kids, teen-agers, who don’t smoke, but are looking for a little bit of a buzz? If it’s sitting on the shelf of a mom-and-pop store or a pharmacy, and they can just walk in and buy it, will nicotine become the next buzz?”

Nicotine, which numerous health and drug abuse experts have declared addictive, is associated with heart disease and affects the brain and fetuses. The debate over the use of nicotine replacement products often has focused on whether users simply trade one harmful habit for another.

The health dangers from cigarettes--which include lung cancer, emphysema and other respiratory ailments and heart disease--come less from nicotine than from inhaling the toxic substances produced by burning the tobacco leaf, experts say. Also, nicotine from gum and patches is less rapidly absorbed by the body, and in less concentrations, than in cigarettes.

Smokers who use nicotine patches typically apply a new one each day, usually on an upper arm. At first, the patches usually provide dosage roughly equivalent to the amount of nicotine an average smoker takes in each day--about 25 milligrams. The patch delivers that amount over each 24-hour period for about six weeks.

Over the course of the next month or six weeks, the amount of nicotine dispensed by the patch is gradually lowered to enable the smoker to become accustomed to less and avoid the symptoms of abrupt withdrawal.

Dr. Jack Henningfield, chief of clinical pharmacology research at the National Institute on Drug Abuse, stressed that “not all nicotine medications are created equal.”

An experimental nicotine nasal spray not yet on the market, for example, has proved very successful in clinical studies. However, many individuals became hooked on the spray and found it extraordinarily difficult to give up.

One dose--two sprays--of the nasal drug delivers 1 milligram of nicotine. But unlike the gum and patch therapies, the spray delivers a faster and more direct hit of the drug, similar to cigarettes.

For this reason, an FDA advisory panel last summer said the nasal nicotine drug had significant potential for abuse. If that application is approved, the panel recommended strictly controlling it by prescription, limiting the number of refills and requiring strong warnings.

In contrast, “the majority of people who go from cigarettes to gum or the patch don’t become similarly addicted,” Henningfield said.

The gum and the patch are “incredibly gentle” forms of nicotine delivery compared to cigarettes, “so gentle that many clinicians think you need more aggressive forms of nicotine delivery to treat heavier addicted smokers,” he said. “For those who stay on the medication longer than the original prescription, that’s when you get into a debate: Is it legitimate medical need? Or abuse?”