WASHINGTON — Doctors typically wait until smokers are ready to quit before prescribing pills to help them do it. But a new study has found that even for those who are not ready to stop smoking immediately, medicine taken over time can substantially improve their chances of eventually quitting.
Clinical practice guidelines have long advised doctors to have their patients set a precise quit date before prescribing medicine such as Chantix, the pills used to treat nicotine addiction that were examined in the study. The idea was that such medicine should not be prescribed for someone who is not serious about quitting. In some cases, insurance plans would not pay for the pills if no quit date had been set.
But in a study published in JAMA on Tuesday, researchers found that even for patients who wanted to stop smoking eventually, the pills were effective, opening the way to a much larger population of patients whom doctors could potentially treat.
David Abrams, executive director of the Schroeder Institute for Tobacco Research and Policy Studies, said studies of nicotine replacement therapy, such as patches and gum, had long shown that attempts to quit gradually over time are a good way to change lifetime habits. The current study appears to show the same for pills, he said.
“Sometimes serious addiction needs to be coaxed down the stairs one at a time, not thrown off the top floor,” said Dr. Abrams, who was not involved in the study.
The study was funded by Pfizer, the drug company that makes Chantix, a treatment that costs about $250 a month. Federal regulators require companies to conduct studies proving the effectiveness of such therapies, and monitor them closely. The practice is common for smoking cessation therapies, said Robert West, director of tobacco studies at University College London, who was among the study’s authors. If such studies were funded by the government, which sustains a lot of academic research, taxpayers would bear the burden for what the company would eventually profit from, he said.
Still, some researchers not involved in the study said the topic required more work.
“The approach taken here is a very reasonable one that appears to have been successful,” said Gary A. Giovino, a professor of health behavior at the State University of New York at Buffalo. “But the findings from one study do not make a fact. We need more studies, funded by someone other than the company that makes the product.”
Smoking is the largest cause of preventable death in the United States, killing more than 480,000 Americans a year. The smoking rate has declined substantially since the 1960s, but the pace of decline has slowed in recent years and health experts are trying to figure out how to get more smokers to quit.
About 1,500 patients at 61 clinics in the United States and abroad participated in the study. None were willing to quit immediately, but all said they wanted to smoke less and to quit for good within three months. They were randomly assigned to two groups. One got Chantix, the brand name of the drug varenicline, which is taken twice a day by mouth as a pill; the other group got a placebo.
Almost a third of the patients who got the drug quit within six months of starting the pills, compared with 6 percent who took the placebo. The study did not follow patients long term, so it was unclear whether those who quit smoking had permanently rid themselves of the habit.
The study cited a survey of smokers that found about a third of the 42 million smokers in the United States wanted to quit in the next one to six months, and concluded that the more gradual treatment could be effective for as many as 14 million American smokers.
It is unclear what the finding will mean for the clinical guidelines, which were set most recently in 2008 by a panel of experts convened by the Public Health Service, which is part of the Department of Health and Human Services.
The study’s authors said the findings had the potential to change practice.
“It’s a paradigm shift because instead of only giving the medication to patients who have set a quit date, you are potentially giving it to every smoker,” said Dr. Jon O. Ebbert, one of the authors, who is a professor of medicine at the Mayo Clinic College of Medicine in Minnesota. “It opens the door to a much larger population of smokers that we can treat.”
Most surprising, he said, was the fact that the rates of quitting for smokers in this study who received the treatment and did not want to quit right away were about the same as those in previous studies of patients who wanted to quit abruptly.
This story covers a Pfizer-sponsored study that compared Chantix (varenicline) to placebo in a group of smokers who were willing to gradually reduce their cigarette consumption — with the goal being smoking cessation. The headline is somewhat misleading on that point, and the story never completely clarifies that the participants were willing to start cutting down on cigarettes with an eye toward quitting entirely — they just didn’t want to go “cold turkey.” The story has several strong points, including its discussion of costs. We wished for more information on the potential side effects of varenicline and a more complete listing of alternative smoking cessation therapies.
Smoking is a major health problem in the United States. The CDC reports that approximately one in five deaths in the United States is tied to smoking-related health effects. Smoking is linked to a significant increase in health risks related to heart disease, cancer, and stroke. These health problems come with a high economic cost. The CDC estimates that smoking is responsible for “at least $133 billion for direct medical care of adults and more than $156 billion in lost productivity” in the U.S. Anything that can help smokers kick the habit has the potential to significantly benefit both public health and the economy.
The story makes clear that Chantix costs approximately $250 per month. The story also notes that some insurance companies would not cover the cost of smoking cessation drugs if an individual has not set a quit date. However, it’s not clear how many insurance companies will pay for smoking cessation drugs at all, or how many would pay for the drugs without a quit date.
There are two ways to think about benefits here: the benefit of quitting smoking and the benefit of using the smoking cessation drug. The story addresses both, but not equally well. First, the story tells readers that using the drug made it more likely that a smoker could successfully wean their cigarette consumption to zero within six months. And it provides statistics to back that up: “almost a third of the patients who got the drug quit within six months of starting the pills, compared with 6 percent who took the placebo.” Second, the story notes that smoking is the leading cause of preventable death in the U.S. While that’s useful information, the story would have been even better if it had addressed how and whether quitting smoking reduces health risks. For example, how long does someone have to be smoke-free before they see health benefits from not smoking?
We’d also note that the headline for this story is somewhat misleading. It says that the drug is effective for smokers “even before [they] are ready to quit.” That’s not as precise as it could have been. The subjects were indeed willing to quit, they just didn’t want to go “cold turkey.” The story compounds this problem when it quotes the author of the Pfizer-sponsored study who says, “It’s a paradigm shift because instead of only giving the medication to patients who have set a quit date, you are potentially giving it to every smoker.” But again, we’re not really talking about giving the drug to “every smoker” — just those who want to quit soon, but aren’t willing to go cold turkey.
The story specifically focuses on the use of varenicline, which goes by the trade name Chantix, but does not mention any of the possible adverse health effects associated with the drug. These possible side effects include changes in mood, suicidal thoughts, and cardiovascular problems — all of which are worth mentioning.
The story does a good job of explaining the relevant study, giving information on the size of the study, the study design, and the outcomes. The story also links directly to the journal article describing the study — which is always a plus. As noted above, the story could have been clearer about the study participants’ level of motivation.
The story does not exaggerate the health effects of smoking, although one could argue that it engages in mild “treatment mongering” of smoking cessation via the headline and a very enthusiastic quote that stretch the potential benefits of the drug.
The story does clearly state the relevant study was funded by Pfizer — the drug company that makes Chantix. That’s good. However, the story quotes only three sources. Two of them are authors of the relevant study. The third is David Abrams, who heads the Schroeder Institute for Tobacco Research and Policy Studies. A quick internet search finds that Abrams has also done smoking cessation research with funding from Pfizer. The story would have benefited from input from an expert with no ties to Pfizer’s smoking cessation research.
We give the story credit for noting that the “rates of quitting for smokers in this study who received the treatment and did not want to quit right away were about the same as those in previous studies of patients who wanted to quit abruptly.” That’s good context. However, the story does not mention that the competing drug bupropion (sold as Zyban and Wellbutrin) has also been shown to offer some benefit in smokers who prefer to gradually reduce cigarette consumption over abrupt discontinuation. That’s an important omission.
The story makes clear that Chantix is already on the market.
The story notes that gradually cutting down on smoking, with the help of patches and gum, is an established way to change habits. However, it suggests that the current study “is the first that appears to show the same for pills,” which is not entirely accurate. As noted above, the competing drug bupropion has been studied in this context and shown to offer potential benefits. Since this is essentially the same problem that we noted above under “Alternatives,” however, we won’t penalize the story again for this omission.
The story includes quotes from sources that are not included in JAMA’s news release on the journal article.