Nicotine patch rules condemned
12/12/01
Health campaigners have attacked "myopic" regulations over the use of nicotine replacement therapies.
They say the restrictions on the use of nicotine replacement therapy (NRT) do not take into account the fact young people, pregnant smokers and smokers with cardiovascular disease already use nicotine in its much more harmful form in cigarettes.
They called for a review of regulation of NRTs, and called for them to be as widely available as cigarettes.
Campaigners including UK-based Action on Smoking and Health (ASH) say regulators, such as the Medicines Control Agency, create "unwarranted obstacles" to the wider use of NRT - and promote increased smoking.
The criticisms come in a review of evidence published in the journal Addiction, and in a declaration to be published under the auspices of the World Health Organization from a conference in Prague this week.
They say there are "off-putting" restrictions and "distracting" warnings on NRT products such as patches and gum.
The paper says NRT should be used for smoking reduction, temporary abstinence and as a long-term alternative to smoking.
Warnings 'create nervousness'
Dr Ann McNeill, honorary senior lecturer at the department of psychology at St George's Hospital Medical School, the lead author of the paper in Addiction said: "It's simple really - the more the regulators place stringent regulations on the use of NRT, the more likely it is that people will continue to smoke, and then die as a result."
She added: "They don't properly consider the risk of not using the product when they place restriction and warnings on the packs.
"The restrictions and stern warnings just make smokers and their doctors nervous, yet smoking is thousands of times more dangerous."
Clive Bates, director of ASH who co-authored the paper said: "This is a serious case of regulatory myopia, in which the obvious reality of smoking as the main way of taking nicotine has somehow been overlooked when it comes to deciding how to handle nicotine in its safest form.
"The regulators have a ludicrous approach to NRT - it's like refusing to throw a life belt to a drowning man because they're worried that it might hit him on the head or the plastic might be toxic if he accidentally swallows it.
"If the regulator or medical professional was liable for the consequences of not treating a smoker with NRT, we'd soon see these restrictions come off."
System failure
He added: "It's easy to explain why the regulators adopt the ostrich posture when it comes to NRT products - if a smoker has a problem when using the drug, the regulator or medical professional might be blamed.
"If the smoker doesn't use the drug, but continues to smoke and suffers the consequences of smoking, then the smoker is to blame. The system works to protect regulators and doctors, but does little to protect the poor old smoker."
Dr Jonathan Foulds, associate professor at the University of Medicine and Dentistry of New Jersey, School of Public Health, who also worked on the paper, said: "In many countries of the world you need a doctor's prescription to get the nicotine inhaler but you can buy cigarettes almost anywhere.
"What kind of crazy system is it that makes it so much easier to get the most dangerous product and so hard to get the treatment?"
A Department of Health spokesman said: "Young people, pregnant women and patients with heart disease are all able to use NRT products on the advice of a doctor.
"This is because the risks and benefits of using NRT in these groups needs medical assessment."
He added patches, gum and lozenges were now on general sale, and all other NRTs were are available without prescription from chemists.