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On February 4, World Cancer Day, the Institute of Medicine (IOM) of the National Academies released a new report, "Cancer Control Opportunities in Low- and Middle-Income Countries." The report states that the causes of and outcomes for cancer in developing countries are different from conditions within more affluent, developed countries, and notes that a "one-size-fits-all" solution for cancer control in the developing world is impractical. Instead, IOM recommends a number of unique, resource-appropriate strategies to control and combat cancer.
The report, sponsored by NCI's Office of International Affairs (OIA) and the American Cancer Society, was developed to address the fact that cancer already represents a significant disease burden in low- and middle-income countries. The report focuses on the opportunities in these countries to improve cancer prevention, surveillance, treatment, and palliative care. . . .
The IOM report contains several recommendations. First among these is that every developing nation create a cancer control plan. It also recommends that each country sign, ratify, and implement the Framework Convention on Tobacco Control of the World Health Organization.
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1. Manufacturers of tobacco products, whether conventional or modified, should be required to obtain quantitative analytical data on the ingredients of each of their products and to disclose such information to the regulatory agency.
2. All tobacco products should be assessed for yields of nicotine and other tobacco toxicants according to a method that reflects actual circumstances of human consumption
There is little evidence that products like nicotine patches and gums, which help reduce a smoker's reliance on traditional tobacco products like cigarettes, actually reduce the risk of smoking-related disease, according to a new report. . .
The cautious tone of the researchers is due in part to the way lower-nicotine and lower-tar (or "light") cigarettes were decades ago first embraced as a way to reduce the levels of nicotine and harmful chemicals that smokers inhaled. . .
professor and chief of the cancer genetics and epidemiology program at the Lombardi Cancer Center at Georgetown University Medical Center. "We had basically a public health experiment where everyone from the surgeon general said, 'If you have to smoke, go to the low-tar nicotine' and we made a mistake once. So we're really scared about making the same mistake again." . .
So what is the best way to quit? For some people, a combination of different products and approaches is best, says Nate Cobb, lead developer of the QuitNet, a smoking cessation Web site (www.quitnet.org) run by Join Together, a project of the Boston University School of Public Health.
"What we do know is that absolutely, the patch, gum, and Zyban, or bupropion--they work," says Cobb.
A blue-ribbon scientific panel is calling for federal regulation of "safer" cigarettes, saying there isn't enough evidence to conclude that any of the new, supposedly reduced-risk products hitting the market will actually decrease the health dangers of smoking.
"The only way to ensure that the health claims made about these products are true" -- and "the public is fully and accurately informed" -- is through new rules governing their development and marketing, said Stuart Bondurant, a physician who is chairman of the expert committee. . .
Seth W. Moskowitz, a spokesman for Reynolds, said the company is "pleased" that the institute's panel "believes that reduced-risk cigarettes should be part of sound public-health policy and that cigarette manufacturers should be encouraged to develop reduced-risk tobacco products." In Dallas, Reynolds is test-marketing the Eclipse
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. . .
"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." . .
"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."
Written by a panel of 12 doctors and scientists for the academy's Institute of Medicine (IOM), the report recommends that tobacco companies be allowed to market cigarettes claiming to reduce risk only after a federal agency has scientifically concluded that they are "not false or misleading." Currently there is no federal authority to regulate tobacco.
In addition, the report concludes that manufacturers should be required to identify and disclose the toxic components of cigarettes designed to be safer so their possible link to disease can be assessed. There are more than 4,000 chemicals in tobacco smoke, and many are known to be toxic.
GlaxoSmithKline (GSK) supports the Institute of Medicine (IOM) of the National Academy of Sciences for investigating how to reduce the harm caused by tobacco use. We concur with the IOM's recommendation that more research on the wide variety of possible harm reduction approaches is needed.
However, nicotine replacement therapies, including GSK's Nicorette(R) nicotine polacrilex gum and NicoDerm(R) CQ(R) transdermal patch, are currently approved by the Food and Drug Administration as safe and effective first line therapies to help smokers quit. In fact, in recent clinical practice guidelines for treating tobacco dependence released to physicians and the most recent Surgeon General's report, physicians were strongly encouraged to recommend that their smoking patients use FDA approved products such as Nicorette and NicoDerm CQ to quit smoking. It is also important to note that some of the press coverage quoting the IOM report mistakenly point out that nicotine replacement therapy contains tobacco. Nicotine patches and gum approved by the FDA do not contain tobacco.
Although these products have already helped millions of Americans quit, nicotine replacement therapies are not indicated for harm reduction nor marketed for this purpose. If scientific evidence supports nicotine replacement therapy for use in harm reduction, GSK would consider pursuing this indication by obtaining FDA approval.
So-called 'light' or low-tar cigarettes may not be any safer than standard tobacco products, and may in fact increase smoking as new users turn to these purportedly 'harm-reduced' alternatives, according to an expert panel.
``We believe that it may be possible to reduce harm from tobacco use with new products, but we frankly do not know the health effects of the various products on the market today that claim to do this,'' explained panel chair Dr. Stuart Bondurant of the University of North Carolina, Chapel Hill.
In a statement from the US Institute of Medicine(IOM) at the National Academy of Sciences, which sponsored the report, Bondurant added that since many 'light' products still contain tobacco, ``the effects of these new products must be studied carefully to make a reliable judgment as to whether they actually reduce risk and harm.''
Cigarettes made with modified tobacco or designed to burn at low temperatures do not necessarily deliver on promises to make smoking safer and may even be dangerous, a panel of experts said on Thursday.
And aids meant to help people kick the habit, such as nicotine patches, gum and antidepressants, may have their own side-effects, according to a committee, appointed to advise the government.
They urged the industry, government and independent researchers to do more studies to show whether the products reduce the toxins that smokers take in -- or encourage people to smoke more because it seems less dangerous.
They also recommended legislation that would tighten federal regulation of all tobacco products. . .
Bondurant and colleagues appointed by the Institute of Medicine (IoM), one of the National Academies of Sciences, were asked by the FDA to look at the claims of such products in 1999. They conclude that it is hard to say whether they work.
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The conclusions of our report can be summarized in four points.
Pharmaceutical and modified tobacco products designed to reduce the health risks of smoking cannot yet be proved to reduce tobacco-related disease, says a new report from the Institute of Medicine (IOM) of the National Academies. Products developed to lessen the risk of disease by reducing exposure to toxic chemicals are scientifically feasible, but in the absence of rigorous research, no one knows if these products decrease the incidence of tobacco-related disease or actually increase it by encouraging smoking.
The report outlines how tried-and-true public health tools -- research, surveillance, communication, and regulation -- should be used to ensure that the availability of these products confers less risk to the individual and to the population as a whole compared with conventional tobacco products. It recommends a regulatory strategy to assure that these products reduce risk of disease. Other potential regulatory approaches to tobacco control are not addressed. . .
In 1999, the U.S. Food and Drug Administration (FDA) called on the IOM to provide a framework for assessing "harm-reduction" products that allow the user to continue to smoke. The array of such products includes modified tobacco and cigarette-like items that deliver smaller amounts of toxicants. Drugs -- such as an antidepressant and nicotine in gum, patches, inhalers, and nasal spray -- are strictly regulated by the FDA for short-term use to help people quit smoking, but they are not approved for long-term use in harm reduction. Modified tobacco and cigarette-like products are not regulated by the FDA or any federal agency for their potential to reduce tobacco-related disease. The recent introduction of these products to the marketplace and growing competition between the industries to develop more of them make it urgent that such products are studied, and that information about them is easily and accurately communicated to consumers, the committee said.
To demonstrate that these products decrease exposure to tobacco toxicants, they must be tested in the exact way that people would use them, the committee said.
A strategy of harm reduction is likely to succeed, the committee said, only if manufacturers have the incentive to develop and market products that reduce harm; consumers are accurately informed of all known and potential consequences of using these products; if advertising and labeling are firmly regulated to prevent false or misleading claims; if basic, clinical, and population studies are conducted to indicate reduced harm; and if health effects of using these products are continually monitored. Most important, the committee stressed the need to make harm reduction a component of a comprehensive national approach that includes the prevention of smoking initiation and relapse, as well as the promotion of smoking cessation.<I>Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction</I>