The story explained in clear terms why nicotine gum is under scruitny right now and who is pushing for its expanded use. It listed many of the side effects of using the gum and explained nicotine addiction simply and elegantly.
We wish, though, that it had presented more of the hard data from some of the studies that receive only fleeting mention, that it had provided cost information and that it had done more to discuss alternatives to nicotine gum.
On the safety record for nicotine gum all we got in this story was one health behavior specialist saying, “There really doesn’t appear to be any great harm.” And a British regulatory proclamation that “there are no grounds to suspect appreciable long-term adverse effects.” Statements like “doesn’t appear to be” and “no grounds to suspect” could be haunting some day. The story states that NRT products have “amassed a strong safety record” but we’re never given any details.
We also wish it had presented a more balanced perspective from the sources quoted. The two nicotine replacement users are probably not examples of how nicotine products are used widely. The use of nicotine replacement at high dose for 15 years is well outside any regulatory boundaries anywhere.
As the story points out, “About one in five American adults smokes—a rate that has remained virtually unchanged since 2004.” As other studies have found, about 1 out of every 5 preventable deaths is also due to smoking. This is a massive public health challenge. People take up smoking and continue to do so despite the known risks for a variety of reasons. Just about 50% of smokers attempt to quit each year. Most fail. A major reason for the failure is the addictive power of nicotine. A story that highlights the public and personal health issues associated with smoking and smoking cessation is always welcome.
The story did not discuss costs, and this was a missed opportunity. Cigarette smoking creates a huge burden on our health care system. The cost of the gum – $50 to $70 for a box of 100 pieces – may be a drop in the bucket compared to the costs of people developing cancer and other disorders from smoking. A study mentioned in the story has a nice section on costs that we wish the story had quoted: “…the incremental cost of extended versus standard therapy was $2482 per additional quitter at 24 weeks.”
The benefits are the whole reason for this story and yet they are not quantified in any way. The story says, “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.” Readers deserved to see the hard numbers.
Although some potential harms are mentioned, none are quantified.
The story states that NRT products “have amassed a strong safety record” but we never get any details on that record.
We wish the story had delivered a deeper exploration than one health behavior specialist saying, “There really doesn’t appear to be any great harm.” And a British regulatory proclamation that “there are no grounds to suspect appreciable long-term adverse effects.” Statements like “doesn’t appear to be” and “no grounds to suspect” could be haunting some day.
The story mentions numerous studies and could not possibly evaluate all of them in detail, but we felt that more time could have been spent with at least one or two of the studies to help readers understand the types of studies that have been done and the relative strength of the findings. The way the story reads, all the studies are essentially given equal weight. And then there is this curious bit of information. “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.” Were the clinical trials themselves not hard science? Wasn’t this, in effect, a conservative approach based on what hard evidence was available? The University of Pennsylvania study, which studied the nicotine patch and not gum, failed to show any difference in smoking rates at the end of one year, even though it did show a difference up to the 24 weeks of treatment. So, the bottom line suggested in the story is that people are likely to stay off cigarettes as long as they can get nicotine in some other form. While that seems reasonable on face value, we are only given a couple of anecdotes and a partial rendering of a single study. The two anecdotes provided strongly suggest that continuing an ongoing use of nicotine replacement for years is both acceptable and safe.
The story does not engage in disease-mongering.
The story only quoted one scientist in a story that was ostensibly all about the science. Instead, it spent more time with nicotine gum users and a blogger. We thought that had more space been devoted to independent experts, the evidence would have been more clearly sorted out. We did appreciate, though, that the story took pains to point out the extent of drug industry funded research in this area. It says, for example, “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.”
The story did not do a good job comparing nicotine gum to going cold turkey, counseling or other therapies. Some of the studies mentioned talk about a combination of therapies that include gum and counseling. We would have liked to have seen a better comparison to give readers the best sense of what choice they should make if considering quitting smoking.
The story makes it clear that these over-the-counter drugs are widely available and that Nicorette is the market leader. ‘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.”
The story does a good job establishing what’s truly novel here – “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.”
It’s clear that the story didn’t rely on any news release.