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The lesser of two evils

发布时间:2019-03-08 04:02:01来源:未知点击:

By Michael Day IT IS one of America’s great ironies. The US Food and Drug Administration, possibly the toughest regulatory agency in the world, has no power to regulate a drug that hooks millions, then kills half its users prematurely. The dangers of the drug, nicotine, and its delivery vehicles, cigarettes, cigars and pipes, are well documented. Yet it remains outside FDA jurisdiction. That may be about to change. Last week, the US Supreme Court agreed to hear an appeal from the FDA on this very point. The decision follows years of legal wrangling. The FDA first argued it should have control over tobacco in August 1996, in a North Carolina district court. That hearing went in the FDA’s favour, but the decision was reversed by a court of appeal, following a challenge from the tobacco industry. In this latest appeal, the Supreme Court’s verdict is expected in 12 months’ time. Ed Sweda, senior attorney with the Tobacco Products Liability Project, an anti-smoking lobby group based at Northeastern University in Boston, says he expects the court to find in favour of the FDA. This would be a huge blow for the tobacco industry, says John Slade, an expert on addiction from the University of Medicine and Dentistry of New Jersey, in Newark. FDA control would mean safer cigarettes on the market, he says. Last month the London-based campaign group Action on Smoking and Health (ASH) listed dozens of devices patented by cigarette makers, including special filters and tobacco treatment processes, that could reduce levels of key toxic substances in cigarette smoke (This Week, 6 March, p 4). The fact that none has found its way into cigarettes on sale to the public is revealing, says ASH. Clive Bates, the group’s director, suggests that companies feared that using them would be tantamount to admitting their products were dangerous—adding to their already considerable litigation woes in the US. Dick Daynard, a colleague of Sweda’s at Northeastern University and the Tobacco Products Liability Project, who has played an influential role in litigation against tobacco firms in the US, calls the manufacturers’ failure to introduce such devices “a criminal level of negligence”. But not everyone is so severe. Slade points out that tough advertising restrictions and mandatory health warnings on cigarette packets mean that the industry would not be allowed to promote altered brands as “safer”. This gives them little incentive to invest in safer cigarettes, he says. Slade and Sweda believe companies will only produce less harmful cigarettes when they are forced to. “If they’re going to incorporate these devices, they’ll have to be made to do it,” says Sweda. But there are signs that safer tobacco may already be on its way, even without the strong arm of the FDA. Star Scientific, a company in Petersburg, Virginia, with a staff of just 100, has spotted a potentially lucrative niche in the anti-smoking market. The company, formerly Star Tobacco, produces profitable discount brands of cigarettes. But it is also committed to helping people stop smoking: it operates a no-smoking policy in its premises and pays staff $500 cash bonuses if they kick the habit. Star’s ultimate aim is to transform itself into a manufacturer of smoking cessation devices. The company has patented a method of removing virtually all the tobacco-specific nitrosamines—the chemicals thought to be the biggest cancer hazard in tobacco smoke—from its tobacco. A microwave process kills the bacteria in tobacco that produce nitrosamines. Star began looking into ways of removing nitrosamines after the FDA blocked its attempt to sell nicotine gum because it contained small amounts of the chemicals. Strangely, though the FDA has no power over cigarettes, it does have authority over chewing gum. The company’s spokesman and legal representative, Paul Perito, says the FDA has been very supportive, and has even advised Star on which scientists to turn to for help in developing its low-nitrosamine cigarette. Independent tests carried out at Virginia Commonwealth University in Richmond show that the new curing process slashes nitrosamine levels in smoke by more than 90 per cent and halves levels of carbon monoxide and tar. According to Star, one of the tobacco giants has ordered a 680-tonne batch of the treated tobacco. The company, which Star can’t name because of a confidentiality clause, “must be taking it pretty seriously if it’s ordering that much”, says Jonnie Williams, Star’s executive vice-president. He claims that all the major cigarette manufacturers have made either direct or indirect inquiries about Star’s product, and predicts that the safer tobacco will begin to be used in cigarettes within 18 months. Star’s approach of reducing the harm caused by cigarettes has the backing of some prominent anti-smoking campaigners, including Slade and Bates. Other advances are in the pipeline, says Jerome Jaffe, the firm’s chief medical consultant and a former US “drugs tsar”. He hints that these may build on the recent finding that addiction may be made worse by the presence in cigarette smoke of chemicals called monoamine oxidase inhibitors (MAOIs), a class of chemicals that have been used as drugs for treating depression. Jaffe suspects that smokers may be addicted not just to nicotine but also to these antidepressant drugs as well. But low-nitrosamine cigarettes are first on the starting blocks. Star plans to make the most of the Canadian government’s proposal to single out nitrosamines as the main cancer-causing chemicals in tobacco smoke. Its federal health ministry, Health Canada, has proposed that information about the levels of nitrosamines, as well as 48 other types of chemical, be printed on cigarette packets. Luc Ladouceur, director of the ministry’s Office of Tobacco Control in Ottawa, cautions that we can’t yet be sure whether nitrosamine-free cigarettes will be safer. “There’s a good chance they would be,” he says. “But we’d need to do the tests.” One of his advisers, Murray Kaiserman, is even more wary. By reducing one class of chemicals, he warns, you could accidentally increase the levels of other dangerous products. Jaffe says that he has measured levels of key substances such as carbon monoxide in smoke from treated tobacco, and so far has found them no higher than normal. Kaiserman says his main concern is about how “safer” cigarettes would be marketed. “The major risk would be if companies were able to promote this change as a significant improvement and oversell it,” he says. He fears that this might lead to a rise in smoking. However, a report commissioned by Ladouceur, due out later this month, will argue largely in favour of making cigarettes tamer. Bates sees no conflict between making cigarettes less dangerous and discouraging people from smoking. Nicotine addiction is a long-term problem that requires long-term solutions, he says, but that is no reason not to produce less dangerous cigarettes in the meantime, just as we produce less dangerous and polluting cars. “We know we can make these products safer and that’s what we should be doing,