THE LESSER OF TWO EVILS

FOCUS:

If people can't stop smoking, the next best thing is to make tobacco less
harmful

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
antismoking 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.

Lucrative niche

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 antismoking 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. Starts 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 remov.ing 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.

Taking the cure

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 tofor 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, Starts 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," he says.