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| Star Tribune |
| Friday, February 23, 2001 |
If cigarettes are bad for you, wouldn't it be better to use nicotine patches, nicotine gum, a nicotine inhaler or even a reduced-smoke cigarette being tested by tobacco companies?
Not necessarily, a research panel of the Institute of Medicine said Thursday. While most replacement products can be used safely as part of a stop-smoking program, there's no evidence that making a new habit out of them would be any safer.
The panel was convened at the request of the Food and Drug Administration in 1999, partly as a response to the test-marketing of so-called reduced-risk cigarettes by major tobacco manufacturers.
"There are going to be a lot of harm-reduction products coming out on the market," said Dorothy Hatsukami, a University of Minnesota professor and member of the panel. "It is important for consumers to be aware that there isn't any data that use of these products will result in reduced harm or reduced risk for disease."
R.J. Reynolds is testing Eclipse, a product that heats the tobacco rather than burns it, while Philip Morris is testing Accord, a similar product that uses a special $50 battery-operated lighter.
Although both products are being tested in some markets, they are not available in Minnesota stores. However, Eclipse is being sold nationwide through a Reynolds Web site.
"All of the products that have been proposed to date from the tobacco industry represent risky products. You are still getting nicotine, you are still inhaling a chemical soup compared to not smoking at all," said Ken Warner, a professor at the University of Michigan and an adviser to the institute panel. "The question is whether they represent a lower level of risk than cigarettes."
Still, the panel did not rule out the possibility that these new products could be less risky than cigarettes themselves. If proven to be safer, then policymakers should see them as an alternative for people who have been unable to quit or won't quit using cigarettes.
"We are pleased that the Institute of Medicine believes that reduced-risk cigarettes should be part of a sound public-health policy," said Seth Moskowitz, an R.J. Reynolds spokesman. "Our company has long been committed to developing cigarettes that might present smokers with less risk."
Still, R.J. Reynolds concedes that Eclipse, because it produces more carbon monoxide than conventional cigarettes, poses an increased risk to those with cardiovascular disease.
Doubts and fears
The research panel cautioned that any research on the new products must include the effects on overall smoking patterns. The fear is that the new products might actually attract people who otherwise would not take up smoking. Or that they could keep smokers from quitting altogether.
The panel pointed to two previous attempts at making smoking safer that backfired. Fifty years ago, smoking rates increased after filters were added to cigarettes, even though filters don't reduce most health risks. The introduction of the low-tar cigarette only caused smokers to inhale more deeply and smoke more to get their nicotine fix.
"The tobacco companies have gotten a lot of people to switch to low-tar cigarettes believing that they have reduced the risk," Warner said. "And if they had never been invented, there are lot of people currently smoking that never would be."
The panel recommended regulatory attention that would monitor the marketing of the new products.
"We are hoping that Congress will enact legislation to give an agency regulatory authority over these products," Hatsukami said. "And we want to make sure that there is going to be money put into research to see if these products lead to reduction of exposure of toxins and reduction of harm."
Hatsukami, director of the university's tobacco research laboratory and treatment programs, said the school has received some government funding to study the medical and policy implications raised by the institute report.
She also said that although she wants to see more research on the long-term effects of nicotine gum and patches, no one should consider them unsafe when used as part of smoking-cessation programs, which are intended to be short-term.
"Nicotine-replacement products to aid in cessation is safe. There is no question about that. However, we really don't have any evidence at this point in time whether long-term use of these products is safe and whether use of these products to reduce the level of smoking is safe, and that is where we need the research."
What is known, she said, is that more and more people are combining patches and gum with cigarettes, or that they are using them for a long time.
While most consumers are not aware of Eclipse and Accord, other cigarette manufacturers have plans to test-market similar products.
Like cigarettes, those new products do not have to satisfy any government regulations before being sold.
By comparison, the nicotine-replacement products -- such as gum, patches, spray and inhalers -- are considered drugs and must be approved by the Food and Drug Administration before they can be sold to the public.
"It is ironic and tragic that we subject the manufacturers of the safest nicotine delivery products ever developed to this hugely expensive process to establish safety and efficacy, and we impose absolutely no regulatory or marketing restrictions on the most deadly form of nicotine ever developed," Warner said.
Glenn Howatt can be contacted at howatt@startribune.com .
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